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KBI Biopharma logo
KBI BiopharmaDurham, NC
At KBI Biopharma, we are advancing science and accelerating breakthroughs. As a global leader in biopharmaceutical development and manufacturing, we empower life science companies to bring new medicines and vaccines to the world faster. Explore your potential at KBI, where innovation meets impact. Position Summary: The Quality Systems team is responsible for establishing and continuously improving the Quality Management System (QMS) that supports the site and Global Compliance activities ensuring systems and business processes are robust, effective, and efficient to comply with required regulations, policies, and guidelines governing the manufacture and holding of materials for our company. The Quality Systems departments goal is support of the site teams to achieve a culture of ongoing regulatory readiness and sustained compliance that delivers safe, pure and effect materials to our clinical and commercial clients. The Senior Quality Assurance Specialist- Client Support is a key Individual Contributor and client projects leader on the Quality Systems team, serving as the Quality-to-Quality client liaison. The incumbent collaborates closely with counterparts throughout the Quality team, supporting processes required to ensure compliance with internal quality documents, regulatory requirements, and cGMP for early and late phase clinical and commercial manufacturing. The incumbent will be responsible for providing support for such activities as product release, deviation, complaint and supplier investigation and closure and facilitating associated collaborations. Additionally, the incumbent will support the compilation, analyzing and reporting of associated metrics. The role requires routine interactions with all functions supporting the external network, including interaction with functions across the company's global network. This role is an onsite hybrid role, working a schedule Monday through Friday between the hours of 8:00 am- 5:00 pm. Responsibilities: Serves as QA facilitator for the Quality aspect of client projects: accountable as the Quality lead, actions coordinator and delegate for the site client project team, joint QA and related meetings. Provides interface between KBI Quality and client regarding batch status, Quality metrics, and Quality issues impacting batch disposition and disposition timeline. Communicates client concerns to KBI teams; facilitates discussions as necessary to resolve client issues. Escalates issues to leadership as needed. Interfaces with the PMO team to ensure Quality topics are addressed. Supports Batch disposition, fully executing the disposition process as needed. Supports audit / inspection readiness of the site. Participates in regulatory and other quality/compliance report-outs; reviews client audit outcomes to ensure appropriate corrective actions are implemented as assigned. Works with Global Compliance to support Client Audits Supports Deviation Management activities by participating in investigational meetings, activities, writing and approving investigation as needed. Assists with compiling, reviewing/ approving Quality Systems and Compliance documentation and reports. Demonstrates knowledge of Quality Systems and functions supporting drug or related FDA governed manufacturing obtained from professional Quality roles. Includes a balance of, from such areas as Supplier Quality Assurance, Compliance, Audits/Inspections, Shop Floor Support, Batch / Material release, Quality document control, review and approval, Validation, QC, Deviations, audit support. Demonstrated ability to keep Project Leads, such as PMs and team members, informed of the status of assigned work. Ability to determine where escalation is necessary. Capability of being flexible as required tasks change and maintain productivity. Requirements: BS/BA Degree in Science or Engineering relevant to the pharmaceutical / Life Science or related industries AS/AA acceptable with 5-7 years of relevant experience as described below. Minimum 5 years prior experience in the Pharmaceutical/Biotechnology industry with a thorough knowledge of Quality Systems, Quality Assurance, and Quality Operations including solid knowledge of global GMP Quality and Regulatory requirements. Minimum of 2 years of previous experience in QA and in a Client-Facing QA or Project Management role Ability to communicate in customer-facing forums to progress issues and obtain positive results. Ability to work professionally with others and facilitate positive interdepartmental interactions with a diverse group of people. Includes ability to navigate conflict to achieve deliverables and drive to targeted outcomes, as well as to resolve differing perspectives with effective negotiation. Listens and is attentive to others' ideas and contributions. Demonstrated ability to be a strong, dependable team-player, yet effective at advancing assignments and projects independently. Voluntarily communicates needs and suggestions clearly and effectively. Demonstrated strong attention to detail and effective investigation, problem solving, and organizational skills. Ability to properly prioritize tasks and manage time effectively. Proactive approach to drive tasks to completion. Excellent written and verbal communication skills. Ability to read, write, and proofread technical documents, investigations, regulatory documents, etc. Ability to compile and analyze data and information from multiple sources Ability to perform basic calculations and data assessment, simple statistics, graphing, plotting data Minimum intermediate proficiency with of Microsoft Office Excel, Word, PowerPoint (Microsoft365). Intermediate proficiency with ERP and QMS systems required, such as SAP, TrackWise, and LIMS p Ability to sit for extended periods of time. Ability to work on site in a manufacturing environment periodically. KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply. I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary. I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.

Posted 30+ days ago

Aliaxis logo
AliaxisAsheville, NC

$26 - $28 / hour

Job Summary Known as an industry leader, focusing on innovation, timely delivery, and personalized service, SILVER-LINE PLASTICS is a manufacturer of some of the industry's highest quality plastic pipe products made in the USA! We offer our customers one most comprehensive product lines in the industry, featuring PVC, CPVC, Polyethylene, Geothermal, and PEX plastic pipe and tubing. Would you like to ply your trade in a state-of-the-art production facility? If so, we currently have an exciting opportunity for a QA Tech based out of our Asheville, NC plant location working 12 hour night shift! Join a collaborative and safety-focused team where your attention to detail and commitment to quality will directly impact the reliability and performance of our products. As a Quality Technician Level B, you will play a key role in ensuring our products meet rigorous standards for usability, safety, and performance. This role offers the opportunity to work with advanced tools and processes, contribute to continuous improvement, and grow within a supportive and inclusive manufacturing environment. At Silver-Line Plastics, we foster a culture of respect, safety, and continuous improvement. You'll be part of a team that values your contributions and encourages professional development. We offer competitive pay, training opportunities, and a chance to grow within a company that values innovation and quality. Key Responsibilities Promote and maintain a safe, respectful, and inclusive work environment through training, adherence to policies, and proactive housekeeping. Perform inspection activities using PI tables, micrometers, and ovality gauges. Ensure tools and equipment meet company standards. Identify and resolve product quality issues. Validate impact and skin testing processes. Investigate non-conforming products and support corrective actions. Support and mentor Process Controllers in quality procedures. Collaborate on material trials and new product evaluations. Monitor production output and run conditions to ensure compliance. Complete documentation and quality reporting accurately. Develop a strong understanding of operational processes and safety protocols. Perform other duties as assigned. Skills & Qualifications High school diploma or GED preferred, but not required. 1-4 years of experience in a quality assurance or technician role. Experience with PI tables, micrometers, and ovality gauges. Familiarity with CSA, UL, ICC, IAPMO, NSF, and ISO standards is a plus. Proficient in using hand tools. Able to work independently and collaboratively in a team-oriented environment. Strong verbal and written communication skills. Physical Requirements Ability to lift up to 50 pounds. Ability to stand, lift, and perform tasks for extended periods. Must be able to wear required PPE (e.g., safety glasses, hearing protection). Ability to work 12-hour shifts and perform repetitive motions. Work Environment Work involves physical activity and exposure to a dynamic manufacturing environment. Exposure to moving machinery, noise, and non-controlled temperatures. Moderate sensory and mental demands due to deadlines and accuracy requirements. Benefits 401K plan with company matching up to 5% Comprehensive Health, Dental, and Vision coverage options 8 paid holidays every calendar year Plant bonus program Set schedule with bi-weekly pay Basic safety equipment (i.e., safety glasses, ear plugs) will be provided Pay $25.78/hr + 10% shift differential = $28.36/hr Shift: 9pm-9am Silver-Line Plastics Corporation is an equal opportunity employer committed to creating an inclusive and accessible workplace. We provide accommodations for individuals with disabilities throughout the recruitment process. If you require accommodation, please contact HR at hr@ipexna.com.

Posted 30+ days ago

PwC logo
PwCRichmond, VA
Industry/Sector Not Applicable Specialism Managed Services Management Level Manager Job Description & Summary At PwC, our people in risk and compliance focus on maintaining regulatory compliance and managing risks for clients, providing advice, and solutions. They help organisations navigate complex regulatory landscapes and enhance their internal controls to mitigate risks effectively. As a risk management generalist at PwC, you will provide advisory and practical support to teams across a wide range of specialist risk and compliance areas. Enhancing your leadership style, you motivate, develop and inspire others to deliver quality. You are responsible for coaching, leveraging team member's unique strengths, and managing performance to deliver on client expectations. With your growing knowledge of how business works, you play an important role in identifying opportunities that contribute to the success of our Firm. You are expected to lead with integrity and authenticity, articulating our purpose and values in a meaningful way. You embrace technology and innovation to enhance your delivery and encourage others to do the same. Examples of the skills, knowledge, and experiences you need to lead and deliver value at this level include but are not limited to: Analyse and identify the linkages and interactions between the component parts of an entire system. Take ownership of projects, ensuring their successful planning, budgeting, execution, and completion. Partner with team leadership to ensure collective ownership of quality, timelines, and deliverables. Develop skills outside your comfort zone, and encourage others to do the same. Effectively mentor others. Use the review of work as an opportunity to deepen the expertise of team members. Address conflicts or issues, engaging in difficult conversations with clients, team members and other stakeholders, escalating where appropriate. Uphold and reinforce professional and technical standards (e.g. refer to specific PwC tax and audit guidance), the Firm's code of conduct, and independence requirements. Minimum Degree Required Bachelor's Degree Minimum Year(s) of Experience 5 year(s) Demonstrates extensive knowledge and/or a proven record of success in the following areas: Quickly and agilely learn client HCP and HCO engagement processes and ways of working, analyzing for opportunities to optimize, develop, update, and govern team playbooks, SOPs, and process documentation to ensure operational consistency and compliance; Develop and maintain training plans for both new and existing team members; Designing and delivering training curricula for new hires and ongoing development for existing team members; Keeping training materials current with process changes, client requirements, and industry/regulatory updates; Managing and delivering structured onboarding programs for new hires to ensure smooth integration and readiness; Providing coaching and skills development opportunities to build functional expertise across the team; Partnering with leadership to identify training gaps and address them proactively; Designing and executing quality monitoring frameworks to evaluate managed services team delivery accuracy, compliance, and timeliness of deliverables; Conducting regular quality reviews of outputs (e.g., tiering assessments, contracting, payment processing); Tracking and reporting quality performance metrics; identify root causes of recurring errors and define corrective actions; Partnering with leadership to implement corrective training and process refinements; Leading process improvement and optimization; Serving as a key SME in continuous improvement initiatives, contributing to best practices across global operations; Mentoring junior team members; Supporting the process design and implementation of new client or new markets ensuring a high-level of customer engagement, quality, timeliness, and service-readiness across all regions; Managing deliverables on or ahead of deadlines and reporting any issues/risks beforehand; Experience in life science meetings & events, pharmaceutical device or healthcare setting working with HCPs, HCOs or Patients; Identifying opportunities for efficiency, automation, and standardization within the managed services delivery model; Working closely with the client-dedicated operations team to streamline processes while maintaining quality and compliance; Communicating with senior leadership and senior client stakeholders; Delivering "white glove" customer service; Ability to work in a fast-paced environment, with a strong emphasis on quality and accuracy; Monitoring and managing other responsibilities not necessarily listed but logically inherent to the role; Leading teams of individuals with a positive attitude; Strong English language reading comprehension and writing skills. Travel Requirements Up to 40% Job Posting End Date Learn more about how we work: https://pwc.to/how-we-work PwC does not intend to hire experienced or entry level job seekers who will need, now or in the future, PwC sponsorship through the H-1B lottery, except as set forth within the following policy: https://pwc.to/H-1B-Lottery-Policy . As PwC is an equal opportunity employer, all qualified applicants will receive consideration for employment at PwC without regard to race; color; religion; national origin; sex (including pregnancy, sexual orientation, and gender identity); age; disability; genetic information (including family medical history); veteran, marital, or citizenship status; or, any other status protected by law. For only those qualified applicants that are impacted by the Los Angeles County Fair Chance Ordinance for Employers, the Los Angeles' Fair Chance Initiative for Hiring Ordinance, the San Francisco Fair Chance Ordinance, San Diego County Fair Chance Ordinance, and the California Fair Chance Act, where applicable, arrest or conviction records will be considered for Employment in accordance with these laws. At PwC, we recognize that conviction records may have a direct, adverse, and negative relationship to responsibilities such as accessing sensitive company or customer information, handling proprietary assets, or collaborating closely with team members. We evaluate these factors thoughtfully to establish a secure and trusted workplace for all. Applications will be accepted until the position is filled or the posting is removed, unless otherwise set forth on the following webpage. Please visit this link for information about anticipated application deadlines: https://pwc.to/us-application-deadlines The salary range for this position is: $99,000 - $232,000. Actual compensation within the range will be dependent upon the individual's skills, experience, qualifications and location, and applicable employment laws. All hired individuals are eligible for an annual discretionary bonus. PwC offers a wide range of benefits, including medical, dental, vision, 401k, holiday pay, vacation, personal and family sick leave, and more. To view our benefits at a glance, please visit the following link: https://pwc.to/benefits-at-a-glance

Posted 2 weeks ago

PwC logo
PwCNew York, NY
Industry/Sector Not Applicable Specialism Managed Services Management Level Manager Job Description & Summary At PwC, our people in risk and compliance focus on maintaining regulatory compliance and managing risks for clients, providing advice, and solutions. They help organisations navigate complex regulatory landscapes and enhance their internal controls to mitigate risks effectively. As a risk management generalist at PwC, you will provide advisory and practical support to teams across a wide range of specialist risk and compliance areas. Enhancing your leadership style, you motivate, develop and inspire others to deliver quality. You are responsible for coaching, leveraging team member's unique strengths, and managing performance to deliver on client expectations. With your growing knowledge of how business works, you play an important role in identifying opportunities that contribute to the success of our Firm. You are expected to lead with integrity and authenticity, articulating our purpose and values in a meaningful way. You embrace technology and innovation to enhance your delivery and encourage others to do the same. Examples of the skills, knowledge, and experiences you need to lead and deliver value at this level include but are not limited to: Analyse and identify the linkages and interactions between the component parts of an entire system. Take ownership of projects, ensuring their successful planning, budgeting, execution, and completion. Partner with team leadership to ensure collective ownership of quality, timelines, and deliverables. Develop skills outside your comfort zone, and encourage others to do the same. Effectively mentor others. Use the review of work as an opportunity to deepen the expertise of team members. Address conflicts or issues, engaging in difficult conversations with clients, team members and other stakeholders, escalating where appropriate. Uphold and reinforce professional and technical standards (e.g. refer to specific PwC tax and audit guidance), the Firm's code of conduct, and independence requirements. Minimum Degree Required Bachelor's Degree Minimum Year(s) of Experience 5 year(s) Demonstrates extensive knowledge and/or a proven record of success in the following areas: Quickly and agilely learn client HCP and HCO engagement processes and ways of working, analyzing for opportunities to optimize, develop, update, and govern team playbooks, SOPs, and process documentation to ensure operational consistency and compliance; Develop and maintain training plans for both new and existing team members; Designing and delivering training curricula for new hires and ongoing development for existing team members; Keeping training materials current with process changes, client requirements, and industry/regulatory updates; Managing and delivering structured onboarding programs for new hires to ensure smooth integration and readiness; Providing coaching and skills development opportunities to build functional expertise across the team; Partnering with leadership to identify training gaps and address them proactively; Designing and executing quality monitoring frameworks to evaluate managed services team delivery accuracy, compliance, and timeliness of deliverables; Conducting regular quality reviews of outputs (e.g., tiering assessments, contracting, payment processing); Tracking and reporting quality performance metrics; identify root causes of recurring errors and define corrective actions; Partnering with leadership to implement corrective training and process refinements; Leading process improvement and optimization; Serving as a key SME in continuous improvement initiatives, contributing to best practices across global operations; Mentoring junior team members; Supporting the process design and implementation of new client or new markets ensuring a high-level of customer engagement, quality, timeliness, and service-readiness across all regions; Managing deliverables on or ahead of deadlines and reporting any issues/risks beforehand; Experience in life science meetings & events, pharmaceutical device or healthcare setting working with HCPs, HCOs or Patients; Identifying opportunities for efficiency, automation, and standardization within the managed services delivery model; Working closely with the client-dedicated operations team to streamline processes while maintaining quality and compliance; Communicating with senior leadership and senior client stakeholders; Delivering "white glove" customer service; Ability to work in a fast-paced environment, with a strong emphasis on quality and accuracy; Monitoring and managing other responsibilities not necessarily listed but logically inherent to the role; Leading teams of individuals with a positive attitude; Strong English language reading comprehension and writing skills. Travel Requirements Up to 40% Job Posting End Date Learn more about how we work: https://pwc.to/how-we-work PwC does not intend to hire experienced or entry level job seekers who will need, now or in the future, PwC sponsorship through the H-1B lottery, except as set forth within the following policy: https://pwc.to/H-1B-Lottery-Policy . As PwC is an equal opportunity employer, all qualified applicants will receive consideration for employment at PwC without regard to race; color; religion; national origin; sex (including pregnancy, sexual orientation, and gender identity); age; disability; genetic information (including family medical history); veteran, marital, or citizenship status; or, any other status protected by law. For only those qualified applicants that are impacted by the Los Angeles County Fair Chance Ordinance for Employers, the Los Angeles' Fair Chance Initiative for Hiring Ordinance, the San Francisco Fair Chance Ordinance, San Diego County Fair Chance Ordinance, and the California Fair Chance Act, where applicable, arrest or conviction records will be considered for Employment in accordance with these laws. At PwC, we recognize that conviction records may have a direct, adverse, and negative relationship to responsibilities such as accessing sensitive company or customer information, handling proprietary assets, or collaborating closely with team members. We evaluate these factors thoughtfully to establish a secure and trusted workplace for all. Applications will be accepted until the position is filled or the posting is removed, unless otherwise set forth on the following webpage. Please visit this link for information about anticipated application deadlines: https://pwc.to/us-application-deadlines The salary range for this position is: $99,000 - $232,000. Actual compensation within the range will be dependent upon the individual's skills, experience, qualifications and location, and applicable employment laws. All hired individuals are eligible for an annual discretionary bonus. PwC offers a wide range of benefits, including medical, dental, vision, 401k, holiday pay, vacation, personal and family sick leave, and more. To view our benefits at a glance, please visit the following link: https://pwc.to/benefits-at-a-glance

Posted 2 weeks ago

PwC logo
PwCBaltimore, MD

$99,000 - $232,000 / year

Industry/Sector Not Applicable Specialism Managed Services Management Level Manager Job Description & Summary At PwC, our people in risk and compliance focus on maintaining regulatory compliance and managing risks for clients, providing advice, and solutions. They help organisations navigate complex regulatory landscapes and enhance their internal controls to mitigate risks effectively. As a risk management generalist at PwC, you will provide advisory and practical support to teams across a wide range of specialist risk and compliance areas. Enhancing your leadership style, you motivate, develop and inspire others to deliver quality. You are responsible for coaching, leveraging team member's unique strengths, and managing performance to deliver on client expectations. With your growing knowledge of how business works, you play an important role in identifying opportunities that contribute to the success of our Firm. You are expected to lead with integrity and authenticity, articulating our purpose and values in a meaningful way. You embrace technology and innovation to enhance your delivery and encourage others to do the same. Examples of the skills, knowledge, and experiences you need to lead and deliver value at this level include but are not limited to: Analyse and identify the linkages and interactions between the component parts of an entire system. Take ownership of projects, ensuring their successful planning, budgeting, execution, and completion. Partner with team leadership to ensure collective ownership of quality, timelines, and deliverables. Develop skills outside your comfort zone, and encourage others to do the same. Effectively mentor others. Use the review of work as an opportunity to deepen the expertise of team members. Address conflicts or issues, engaging in difficult conversations with clients, team members and other stakeholders, escalating where appropriate. Uphold and reinforce professional and technical standards (e.g. refer to specific PwC tax and audit guidance), the Firm's code of conduct, and independence requirements. Minimum Degree Required Bachelor's Degree Minimum Year(s) of Experience 5 year(s) Demonstrates extensive knowledge and/or a proven record of success in the following areas: Quickly and agilely learn client HCP and HCO engagement processes and ways of working, analyzing for opportunities to optimize, develop, update, and govern team playbooks, SOPs, and process documentation to ensure operational consistency and compliance; Develop and maintain training plans for both new and existing team members; Designing and delivering training curricula for new hires and ongoing development for existing team members; Keeping training materials current with process changes, client requirements, and industry/regulatory updates; Managing and delivering structured onboarding programs for new hires to ensure smooth integration and readiness; Providing coaching and skills development opportunities to build functional expertise across the team; Partnering with leadership to identify training gaps and address them proactively; Designing and executing quality monitoring frameworks to evaluate managed services team delivery accuracy, compliance, and timeliness of deliverables; Conducting regular quality reviews of outputs (e.g., tiering assessments, contracting, payment processing); Tracking and reporting quality performance metrics; identify root causes of recurring errors and define corrective actions; Partnering with leadership to implement corrective training and process refinements; Leading process improvement and optimization; Serving as a key SME in continuous improvement initiatives, contributing to best practices across global operations; Mentoring junior team members; Supporting the process design and implementation of new client or new markets ensuring a high-level of customer engagement, quality, timeliness, and service-readiness across all regions; Managing deliverables on or ahead of deadlines and reporting any issues/risks beforehand; Experience in life science meetings & events, pharmaceutical device or healthcare setting working with HCPs, HCOs or Patients; Identifying opportunities for efficiency, automation, and standardization within the managed services delivery model; Working closely with the client-dedicated operations team to streamline processes while maintaining quality and compliance; Communicating with senior leadership and senior client stakeholders; Delivering "white glove" customer service; Ability to work in a fast-paced environment, with a strong emphasis on quality and accuracy; Monitoring and managing other responsibilities not necessarily listed but logically inherent to the role; Leading teams of individuals with a positive attitude; Strong English language reading comprehension and writing skills. Travel Requirements Up to 40% Job Posting End Date Learn more about how we work: https://pwc.to/how-we-work PwC does not intend to hire experienced or entry level job seekers who will need, now or in the future, PwC sponsorship through the H-1B lottery, except as set forth within the following policy: https://pwc.to/H-1B-Lottery-Policy . As PwC is an equal opportunity employer, all qualified applicants will receive consideration for employment at PwC without regard to race; color; religion; national origin; sex (including pregnancy, sexual orientation, and gender identity); age; disability; genetic information (including family medical history); veteran, marital, or citizenship status; or, any other status protected by law. For only those qualified applicants that are impacted by the Los Angeles County Fair Chance Ordinance for Employers, the Los Angeles' Fair Chance Initiative for Hiring Ordinance, the San Francisco Fair Chance Ordinance, San Diego County Fair Chance Ordinance, and the California Fair Chance Act, where applicable, arrest or conviction records will be considered for Employment in accordance with these laws. At PwC, we recognize that conviction records may have a direct, adverse, and negative relationship to responsibilities such as accessing sensitive company or customer information, handling proprietary assets, or collaborating closely with team members. We evaluate these factors thoughtfully to establish a secure and trusted workplace for all. Applications will be accepted until the position is filled or the posting is removed, unless otherwise set forth on the following webpage. Please visit this link for information about anticipated application deadlines: https://pwc.to/us-application-deadlines The salary range for this position is: $99,000 - $232,000. Actual compensation within the range will be dependent upon the individual's skills, experience, qualifications and location, and applicable employment laws. All hired individuals are eligible for an annual discretionary bonus. PwC offers a wide range of benefits, including medical, dental, vision, 401k, holiday pay, vacation, personal and family sick leave, and more. To view our benefits at a glance, please visit the following link: https://pwc.to/benefits-at-a-glance

Posted 2 weeks ago

PwC logo
PwCNew Orleans, LA

$99,000 - $232,000 / year

Industry/Sector Not Applicable Specialism Managed Services Management Level Manager Job Description & Summary At PwC, our people in risk and compliance focus on maintaining regulatory compliance and managing risks for clients, providing advice, and solutions. They help organisations navigate complex regulatory landscapes and enhance their internal controls to mitigate risks effectively. As a risk management generalist at PwC, you will provide advisory and practical support to teams across a wide range of specialist risk and compliance areas. Enhancing your leadership style, you motivate, develop and inspire others to deliver quality. You are responsible for coaching, leveraging team member's unique strengths, and managing performance to deliver on client expectations. With your growing knowledge of how business works, you play an important role in identifying opportunities that contribute to the success of our Firm. You are expected to lead with integrity and authenticity, articulating our purpose and values in a meaningful way. You embrace technology and innovation to enhance your delivery and encourage others to do the same. Examples of the skills, knowledge, and experiences you need to lead and deliver value at this level include but are not limited to: Analyse and identify the linkages and interactions between the component parts of an entire system. Take ownership of projects, ensuring their successful planning, budgeting, execution, and completion. Partner with team leadership to ensure collective ownership of quality, timelines, and deliverables. Develop skills outside your comfort zone, and encourage others to do the same. Effectively mentor others. Use the review of work as an opportunity to deepen the expertise of team members. Address conflicts or issues, engaging in difficult conversations with clients, team members and other stakeholders, escalating where appropriate. Uphold and reinforce professional and technical standards (e.g. refer to specific PwC tax and audit guidance), the Firm's code of conduct, and independence requirements. Minimum Degree Required Bachelor's Degree Minimum Year(s) of Experience 5 year(s) Demonstrates extensive knowledge and/or a proven record of success in the following areas: Quickly and agilely learn client HCP and HCO engagement processes and ways of working, analyzing for opportunities to optimize, develop, update, and govern team playbooks, SOPs, and process documentation to ensure operational consistency and compliance; Develop and maintain training plans for both new and existing team members; Designing and delivering training curricula for new hires and ongoing development for existing team members; Keeping training materials current with process changes, client requirements, and industry/regulatory updates; Managing and delivering structured onboarding programs for new hires to ensure smooth integration and readiness; Providing coaching and skills development opportunities to build functional expertise across the team; Partnering with leadership to identify training gaps and address them proactively; Designing and executing quality monitoring frameworks to evaluate managed services team delivery accuracy, compliance, and timeliness of deliverables; Conducting regular quality reviews of outputs (e.g., tiering assessments, contracting, payment processing); Tracking and reporting quality performance metrics; identify root causes of recurring errors and define corrective actions; Partnering with leadership to implement corrective training and process refinements; Leading process improvement and optimization; Serving as a key SME in continuous improvement initiatives, contributing to best practices across global operations; Mentoring junior team members; Supporting the process design and implementation of new client or new markets ensuring a high-level of customer engagement, quality, timeliness, and service-readiness across all regions; Managing deliverables on or ahead of deadlines and reporting any issues/risks beforehand; Experience in life science meetings & events, pharmaceutical device or healthcare setting working with HCPs, HCOs or Patients; Identifying opportunities for efficiency, automation, and standardization within the managed services delivery model; Working closely with the client-dedicated operations team to streamline processes while maintaining quality and compliance; Communicating with senior leadership and senior client stakeholders; Delivering "white glove" customer service; Ability to work in a fast-paced environment, with a strong emphasis on quality and accuracy; Monitoring and managing other responsibilities not necessarily listed but logically inherent to the role; Leading teams of individuals with a positive attitude; Strong English language reading comprehension and writing skills. Travel Requirements Up to 40% Job Posting End Date Learn more about how we work: https://pwc.to/how-we-work PwC does not intend to hire experienced or entry level job seekers who will need, now or in the future, PwC sponsorship through the H-1B lottery, except as set forth within the following policy: https://pwc.to/H-1B-Lottery-Policy . As PwC is an equal opportunity employer, all qualified applicants will receive consideration for employment at PwC without regard to race; color; religion; national origin; sex (including pregnancy, sexual orientation, and gender identity); age; disability; genetic information (including family medical history); veteran, marital, or citizenship status; or, any other status protected by law. For only those qualified applicants that are impacted by the Los Angeles County Fair Chance Ordinance for Employers, the Los Angeles' Fair Chance Initiative for Hiring Ordinance, the San Francisco Fair Chance Ordinance, San Diego County Fair Chance Ordinance, and the California Fair Chance Act, where applicable, arrest or conviction records will be considered for Employment in accordance with these laws. At PwC, we recognize that conviction records may have a direct, adverse, and negative relationship to responsibilities such as accessing sensitive company or customer information, handling proprietary assets, or collaborating closely with team members. We evaluate these factors thoughtfully to establish a secure and trusted workplace for all. Applications will be accepted until the position is filled or the posting is removed, unless otherwise set forth on the following webpage. Please visit this link for information about anticipated application deadlines: https://pwc.to/us-application-deadlines The salary range for this position is: $99,000 - $232,000. Actual compensation within the range will be dependent upon the individual's skills, experience, qualifications and location, and applicable employment laws. All hired individuals are eligible for an annual discretionary bonus. PwC offers a wide range of benefits, including medical, dental, vision, 401k, holiday pay, vacation, personal and family sick leave, and more. To view our benefits at a glance, please visit the following link: https://pwc.to/benefits-at-a-glance

Posted 2 weeks ago

Bristol Myers Squibb logo
Bristol Myers SquibbIndianapolis, IN

$82,236 - $99,650 / year

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us. RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals. Summary The Senior Specialist, QA Operations will help support operations through quality oversight in a Radiopharmaceutical facility in Indianapolis, IN. The Senior QA Operations specialist will be providing oversight over shop floor activities in accordance with regulatory standards and RayzeBio procedures. The Senior QA Operations specialist will also be responsible for material and batch disposition activities. This position will utilize quality assurance knowledge in ensuring compliance in operations to support clinical development and GMP commercial operations in accordance with RayzeBio policies, standards, procedures and global current Good Manufacturing Practice (cGMP). The Senior Specialist provides Quality support and oversight for operations and disposition activities at the Indianapolis facility, including review and approval of Deviations, CAPAs, Change Controls, documents, Batch Records, and Material and Lot Disposition. This person may also interact with the Qualified Person (QP) as needed to facilitate release of EU doses. Job Responsibilities Essential duties and responsibilities include the following. Other duties may be assigned. Build and maintain cross functional relationships to improve processes and resolve issues. Provide quality oversight on manufacturing and validation activities. Perform real time review of manufacturing records. Perform periodic walkthroughs of manufacturing and Quality Control areas to ensure continued compliance with procedures. Provide guidance on the handling of quality and shop floor activities. Support Quality disposition process by ensuring that all required documents are accurately and properly completed and compiled against approved procedures and specifications, including all related deviations. Assist with and provide QA approval of investigations, CAPAs, change controls, validation documentation, and other related GMP documentation. Identify and report discrepancies from required work practices or procedures to management. Make sound decisions by exercising judgment within generally defined practices and policies and applies appropriate notification to management as appropriate. Participate as requested in the response team for audits and inspections by health authorities. Education and Experience BS/MS degree in science related field (including biology, biochemistry, chemistry, engineering, or related areas) is preferred Minimum of 5 years' experience in quality assurance and/or compliance roles in the pharmaceutical industry or a related industry Experience working in a GMP aseptic manufacturing environment preferred. Experience working with FDA or other regulatory authorities is preferred. Skills and Qualifications Expertise in GMP, Quality, material and product disposition Strong capability in authoring and critically reviewing investigations, interpreting results, and generating technical conclusions consistent with Quality risk management principles Detail-oriented with demonstrated applications in problem solving and decision-making abilities with moderate oversight from management Team player who can work independently to achieve objectives in a fast-paced environment Excellent verbal and written communication skills. Strong background and demonstrated effectiveness in quality assurance operation and compliance of clinical/commercial manufacturing is desired. Knowledge of US, EU and rest-of-world cGMP regulations and guidance. Knowledge and proven experience in FDA, EMA, or other regulatory authority. Well-practiced in exercising sound judgment in decision-making. Demonstrated prioritization and organization skills. Physical Demands While performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 30 pounds. Specific vision abilities required by this job include close vision and distance vision. This is a position that requires working in an environment with radioactive materials where protective clothing, gloves, and safety glasses are required. Work Environment The noise level in the work environment is usually moderate. This position may require work outside of normal working hours or on weekends. #LI-ONSITE If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Compensation Overview: Indianapolis- RayzeBio- IN: $82,236 - $99,650 The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/ . Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include: Health Coverage: Medical, pharmacy, dental, and vision care. Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP). Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support. Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown. Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as "Transforming patients' lives through science ", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. Supporting People with Disabilities BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. Candidate Rights BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/ Data Protection We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection . Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley. R1597483 : Senior Specialist QA Operations

Posted 4 days ago

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Wayne Farms, Inc.Decatur Prepared Foods Plant, AL
PRIMARY FUNCTION: Primarily responsible for partnering with internal departments/personnel on assigned process improvement or other short term project which has significant business impact within the sponsoring functional area. Work independently or within a team on assigned project to develop and implement solutions for issues which impact the business bottom line, to improve process efficiency or safety, and/or support regulatory or legal compliance Gather and analyze data, compile into reports, create presentation and present to management and/or Senior Leadership Communicate project progress, including roadblocks or bottleneck, to appropriate personnel; provide solutions for issues which inhibit project progress/completion Perform additional relevant duties as assigned SUPERVISOR RESPONSIBILITIES: None. This is an individual contributor position. Competencies required: Functional/Technical Skills, Action Oriented, Problem Solving, Learning on the Fly and Interpersonal Savvy. EDUCATION and CERTIFICATIONS: Bachelors' degree in an accredited degree program; poultry or animal science preferred EXPERIENCE AND SKILLS: Ability to create and verbally present project outcome/ findings in a concise manner to peers, management and senior leaders Ability to collect and analyze data, formulating logical assumption or hypothesis, and develop long term solution/improvement based on the analysis Ability to be flexible, working non-standard hours as needed to collect data; may travel overnight occasionally Must have exceptional communication skills, both verbal and written, and the ability to resolve issues efficiently and effectively Self-starter with strong organizational skills and the ability to prioritize and manage tasks while maintaining attention to detail SAFETY REQUIREMENTS: Follow departmental and company safety policies and programs Must wear Personal Protective Equipment (PPE) at all times in areas where required We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Posted 1 week ago

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INCOG BioPharmaFishers, IN
Quality Assurance Manager- Batch Review and Disposition Summary Working closely with the Senior Director of Quality, the Manager will be instrumental in championing and developing our new organization's batch review excellence and a culture of precision, scientific rigor, and timely product release decisions. The Manager will need to successfully lead comprehensive batch reviews, make critical disposition decisions, and ensure compliance with all regulatory requirements. The Quality Assurance Manager- Batch Review and Disposition will exemplify excellent analytical skills and develop productive, quality-focused working relationships with Manufacturing, Quality Control, , and cross-functional teams. The Manager will demonstrate excellent written and oral communication skills with the ability to clearly and concisely articulate complex quality decisions and batch disposition rationales to a range of target audiences. The Manager will thrive in a team environment but will also work autonomously utilizing strong scientific judgment and decision-making skills. Essential Job Functions: Lead comprehensive batch record review processes for sterile injectable drug products, ensuring completeness, accuracy, and compliance with approved manufacturing procedures and specifications. Make critical batch disposition decisions (release, reject, or investigate further) based on thorough evaluation of manufacturing data, in-process testing results, and finished product testing. Establish and maintain batch review procedures that ensure timely and accurate evaluation of all manufacturing batches while maintaining the highest quality standards. Lead investigation of manufacturing deviations and out-of-specification results, determining impact on product quality and appropriate corrective and preventive actions. Collaborate with Quality Control to review analytical testing data, certificate of analysis information, and trending of quality attributes across multiple batches. Partner with Manufacturing Operations to review batch execution data, process parameters, environmental monitoring results, and equipment performance records. Ensure compliance with cGMP requirements and regulatory expectations for batch review and release, maintaining detailed documentation of all disposition decisions. Develop and maintain batch review checklists and standard operating procedures to ensure consistent and thorough evaluation processes. Lead cross-functional batch review meetings to discuss complex cases, unusual events, and trending of quality data across product lines. Maintain batch disposition databases and generate reports on batch release metrics, cycle times, and quality trends for senior management. Ensure readiness for regulatory inspections by maintaining comprehensive batch files and being prepared to justify all disposition decisions to regulatory authorities. Train and develop team members on batch review processes, quality systems, and regulatory requirements specific to sterile injectable products. Utilize electronic batch record systems and quality management systems (Veeva, LIMS, etc.) to ensure data integrity and efficient review processes. Apply statistical analysis to identify trends in manufacturing performance and product quality, implementing continuous improvement initiatives. Stay current with regulatory guidance on batch review and release requirements from FDA, EMA, and other global regulatory authorities. Special Job Requirements: Bachelor's Degree required; degree preferred to be in Science (Chemistry, Biology, Biochemistry, Microbiology etc.) Minimum of 6 years of Quality Assurance experience in pharmaceutical manufacturing with at least 4 years focused on batch review and disposition. Expert knowledge of cGMP requirements for batch review, release, and disposition decisions in sterile injectable manufacturing. Experience with regulatory inspections and ability to defend batch disposition decisions to regulatory authorities. Proficiency with electronic quality systems including LIMS and document management systems. Excellent analytical and problem-solving skills with demonstrated ability to make risk-based quality decisions under time pressure. Strong project management skills with ability to prioritize multiple batch reviews while meeting customer delivery commitments. Exceptional attention to detail and ability to identify potential quality issues that may not be immediately obvious. Additional Preferences: Hands-on experience with aseptic manufacturing Quality. Isolator-based aseptic processing experience. 3+ years of experience as a people leader or supervisor. Experience with building processes and procedures. Experience with Continuous improvement, Six Sigma, and/or Lean principles. Additional info about INCOG BioPharma Services: At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business. If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus. INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics. By submitting your resume and details, you are declaring that the information is correct and accurate.

Posted 30+ days ago

Dreyer's Grand Ice Cream logo
Dreyer's Grand Ice CreamLaurel, MD

$75,000 - $90,000 / year

Are you looking to catapult your career by driving high-impact transformation with household brands? Do you crave an entrepreneurial, fast paced and engaging growth assignment working with incredible people from across the globe? At Dreyer's Grand Ice Cream, we are excited to start a new chapter of accelerated growth as part of Froneri - a global pure-play ice cream leader. Come help us transform DGIC into the #1 ice cream brand! With nearly 100 years of winning experience in the U.S, a robust portfolio of powerhouse brands that consumers know and love such as Häagen-Dazs, Drumstick, Dreyer's & Edy's, and the backing and coaching of European-based ice cream experts, we know we have the winning recipe. Headquartered in Walnut Creek, the Bay Area's hub for up-and-coming food trends, our teams across our offices and factories are raising the bar on all things ice cream. We are investing in significant capital expansions to grow our Operations and Supply chain and are transforming how we work at every level to become agile, accelerate growth and elevate our quality. With a renewed focus on frozen treats, our tight-knit team of ambitious innovators are fully immersed in the business and encouraged to flex and make decisions quickly. We are committed to pursuing every great idea and delivering the best ice cream experience for our consumers, when and where they want it. Unleash your potential at Dreyer's Grand Ice Cream and discover what a sweet career we have in store for you! Developing high quality standards and ownership across value chain Job Description: The Quality Supervisor ensures compliance with food safety regulations, monitors production processes, and implements quality control measures to maintain the highest standards in ice cream production. They work closely with production, R&D, and regulatory teams to ensure consistency and excellence in the final product. Lead by example to carry out all duties and specific responsibilities operational Quality and Food Safety Policies and Procedures. Promote the culture change towards behavioral quality improvements Provide expertise to operations for promoting and executing quality to provide customers with exceptional ice cream experience Direct and supervise the quality specialists and quality techs to ensure daily activities promote production of quality ice cream products on the lines Partner with operations management on key quality checks to be completed by line operators. Checks need to be evaluated periodically to ensure they are in line with hold and complaint data. Manage quality hold program and partner with operations to complete lesson learnt (root cause) and implement corrective action identified. Provide trend data to demonstrate effectiveness of corrective action implementation. Provide leadership on customer complaint reduction by partnering with operations on strategies to reduce complaints by using complaint trend data to prioritize actions. Oversee and provide leadership on the net content to establish facility specific rules to ensure compliance to both volume and weight targets Provide support to TAG on new product launches or formulation when requested. Identify, communicate to plant operations and apply "Best Practices" within the facility or from the broader network. Drive improvements and monitor Quality Metrics/KPI's at the facility Challenge all departments on quality and food safety related Provide support to GMP and HACCP, FSMA FSP compliance through out the facility, by coaching operators when on the floor and promoting minimal water use during production. Ensure compliance to internal and external audits i.e. FSSC 22000/Market audits Provide support to local, State and Federal agencies when requested by local quality management Drive Monthly reviews of KPI's and contribute towards meeting the yearly business goals for the facility. Monitor and assess performance of the quality systems, report their effectiveness to management and implement actions for improvement Represent The Froneri Way of working through the behaviors and characteristics in our Operating Model and Core Values Measurable Outcomes CPMU reduction Respect of GMP and distribution of the "lesson learnt " Reduction of pallets on holds Reduction of food safety incidents Being on the shop floor making ice-cream Drive improvements from benchmarking improvements Levels of responsibility Deploy QA standards Achieve QA targets defined at market level (CPMU, RFT, CRQS…) Hold program Net Content execution Qualifications & Requirements: Bachelor's degree in Food Science, Microbiology, or a related field. 2+ years of experience in quality assurance, preferably in the dairy or frozen food industry. Knowledge of HACCP, GMP, and food safety regulations. Strong attention to detail and problem-solving skills. Ability to lead a team and work collaboratively across departments. Proficiency in quality control software and reporting tools. BEHAVIORS AND CORE VALUES: Must consistently showcase the desired behaviors that represent our Core Values. We Take Ownership Stay committed to responsibilities from start to finish Make sound decisions and get into the right level of detail Apply resources to initiatives that add growth, improve efficiencies, or reduce waste We Do What Is Right Choose transparency over convenience, even if it means difficult conversations Set clear roles and responsibilities, enabling everyone to exercise appropriate initiative and judgment Speak up when you see something that does not align to our values and policies We Seek to Improve Strive to continuously improve and innovate to exceed expectations Value feedback from others and encourage open dialogue to understand how we can improve Learn from both successes and failures We Are Better Together Ensure decisions are based on what's best for the whole business Practice inclusion by seeking diverse perspectives Treat everyone with fairness and respect Work Environment In this position, the employee will regularly work with and around others; in a wet and/or humid environment; in areas of high noise level; and around mechanical, electrical, and pressurized equipment. The work is fast paced. Cold Temperatures: Parts of the facility, such as storage and production areas, may be kept at low temperatures. Requires use of cold-protective PPE. May involve standing, lifting, and walking in refrigerated zones for extended periods. Fast-Paced: Workers often operate under strict timelines to meet production quotas. High-speed manufacturing floor with frequent movement, line assignment changes, and tight production timelines. Standing for Long Hours: Many roles require prolonged standing and repetitive tasks. Repetitive hand and arm movements required. Must be able to stand for hours with frequent bending, reaching, and lifting. Food Safety Regulations: Employees must follow hygiene and safety guidelines, including wearing protective gear (gloves, hairnets, etc.). Team-Oriented: Workers collaborate to ensure smooth production and packaging. The position involves frequent exposure to nuts and other potential allergens. The pay scale for this role takes into account the wide range of factors that are considered in making compensation decisions including but not limited to skill sets; experience and training; licensure and certifications; and other business and organizational needs. At Dreyer's Grand Ice Cream, it is not typical for an individual to be hired at or near the top of the range for their role, and compensation decisions are dependent on the facts and circumstances of each case. The pay range for prospective employees in this role is between $75,000.00 and $90,000.00 per year, with opportunities for overtime, shift differential, cold premium pay and annual bonuses (variable depending on company performance). We offer a comprehensive group benefits package including medical, dental, vision, life, paid time off, paid holidays, paid parental leave, 401K plan with employer match and annual contribution available. Dreyer's Grand Ice Cream Inc. provides equal employment opportunities for all applicants, regardless of race, religion, gender, national origin, age, disability, marital status, veteran status, or any other protected characteristic.

Posted 3 weeks ago

PwC logo
PwCSacramento, CA

$99,000 - $232,000 / year

Industry/Sector Not Applicable Specialism Managed Services Management Level Manager Job Description & Summary At PwC, our people in risk and compliance focus on maintaining regulatory compliance and managing risks for clients, providing advice, and solutions. They help organisations navigate complex regulatory landscapes and enhance their internal controls to mitigate risks effectively. As a risk management generalist at PwC, you will provide advisory and practical support to teams across a wide range of specialist risk and compliance areas. Enhancing your leadership style, you motivate, develop and inspire others to deliver quality. You are responsible for coaching, leveraging team member's unique strengths, and managing performance to deliver on client expectations. With your growing knowledge of how business works, you play an important role in identifying opportunities that contribute to the success of our Firm. You are expected to lead with integrity and authenticity, articulating our purpose and values in a meaningful way. You embrace technology and innovation to enhance your delivery and encourage others to do the same. Examples of the skills, knowledge, and experiences you need to lead and deliver value at this level include but are not limited to: Analyse and identify the linkages and interactions between the component parts of an entire system. Take ownership of projects, ensuring their successful planning, budgeting, execution, and completion. Partner with team leadership to ensure collective ownership of quality, timelines, and deliverables. Develop skills outside your comfort zone, and encourage others to do the same. Effectively mentor others. Use the review of work as an opportunity to deepen the expertise of team members. Address conflicts or issues, engaging in difficult conversations with clients, team members and other stakeholders, escalating where appropriate. Uphold and reinforce professional and technical standards (e.g. refer to specific PwC tax and audit guidance), the Firm's code of conduct, and independence requirements. Minimum Degree Required Bachelor's Degree Minimum Year(s) of Experience 5 year(s) Demonstrates extensive knowledge and/or a proven record of success in the following areas: Quickly and agilely learn client HCP and HCO engagement processes and ways of working, analyzing for opportunities to optimize, develop, update, and govern team playbooks, SOPs, and process documentation to ensure operational consistency and compliance; Develop and maintain training plans for both new and existing team members; Designing and delivering training curricula for new hires and ongoing development for existing team members; Keeping training materials current with process changes, client requirements, and industry/regulatory updates; Managing and delivering structured onboarding programs for new hires to ensure smooth integration and readiness; Providing coaching and skills development opportunities to build functional expertise across the team; Partnering with leadership to identify training gaps and address them proactively; Designing and executing quality monitoring frameworks to evaluate managed services team delivery accuracy, compliance, and timeliness of deliverables; Conducting regular quality reviews of outputs (e.g., tiering assessments, contracting, payment processing); Tracking and reporting quality performance metrics; identify root causes of recurring errors and define corrective actions; Partnering with leadership to implement corrective training and process refinements; Leading process improvement and optimization; Serving as a key SME in continuous improvement initiatives, contributing to best practices across global operations; Mentoring junior team members; Supporting the process design and implementation of new client or new markets ensuring a high-level of customer engagement, quality, timeliness, and service-readiness across all regions; Managing deliverables on or ahead of deadlines and reporting any issues/risks beforehand; Experience in life science meetings & events, pharmaceutical device or healthcare setting working with HCPs, HCOs or Patients; Identifying opportunities for efficiency, automation, and standardization within the managed services delivery model; Working closely with the client-dedicated operations team to streamline processes while maintaining quality and compliance; Communicating with senior leadership and senior client stakeholders; Delivering "white glove" customer service; Ability to work in a fast-paced environment, with a strong emphasis on quality and accuracy; Monitoring and managing other responsibilities not necessarily listed but logically inherent to the role; Leading teams of individuals with a positive attitude; Strong English language reading comprehension and writing skills. Travel Requirements Up to 40% Job Posting End Date Learn more about how we work: https://pwc.to/how-we-work PwC does not intend to hire experienced or entry level job seekers who will need, now or in the future, PwC sponsorship through the H-1B lottery, except as set forth within the following policy: https://pwc.to/H-1B-Lottery-Policy . As PwC is an equal opportunity employer, all qualified applicants will receive consideration for employment at PwC without regard to race; color; religion; national origin; sex (including pregnancy, sexual orientation, and gender identity); age; disability; genetic information (including family medical history); veteran, marital, or citizenship status; or, any other status protected by law. For only those qualified applicants that are impacted by the Los Angeles County Fair Chance Ordinance for Employers, the Los Angeles' Fair Chance Initiative for Hiring Ordinance, the San Francisco Fair Chance Ordinance, San Diego County Fair Chance Ordinance, and the California Fair Chance Act, where applicable, arrest or conviction records will be considered for Employment in accordance with these laws. At PwC, we recognize that conviction records may have a direct, adverse, and negative relationship to responsibilities such as accessing sensitive company or customer information, handling proprietary assets, or collaborating closely with team members. We evaluate these factors thoughtfully to establish a secure and trusted workplace for all. Applications will be accepted until the position is filled or the posting is removed, unless otherwise set forth on the following webpage. Please visit this link for information about anticipated application deadlines: https://pwc.to/us-application-deadlines The salary range for this position is: $99,000 - $232,000. Actual compensation within the range will be dependent upon the individual's skills, experience, qualifications and location, and applicable employment laws. All hired individuals are eligible for an annual discretionary bonus. PwC offers a wide range of benefits, including medical, dental, vision, 401k, holiday pay, vacation, personal and family sick leave, and more. To view our benefits at a glance, please visit the following link: https://pwc.to/benefits-at-a-glance

Posted 2 weeks ago

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American Regent LaboratoriesShirley, NY

$70,100 - $85,000 / year

Nature and Scope Ensures quality system compliance with GMPs, procedures and documentation within the company and in keeping with the internal audit program. Interacts with all levels of the organization and maintains on-going dialogue with management. Essential Duties and Responsibilities Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Under supervision, assist with documentation for the closure of investigations. Assist in gathering data for reports, metrics, Annual Product reviews, Quarterly reports and external requests. Scheduling departmental meetings, maintaining meeting minutes and attendance. Maintain departmental records and files (both electronic and manual). Participate in cross-functional project teams as required. Support, coordinate, and assist with regulatory agency audit tasks as required in support of regulatory agency inspections. Support and maintain quality programs, policies, processes, procedures and controls ensuring compliance with current Good Manufacturing Practices (cGMP). Keep training curriculum current. Ensure all work is performed and documented in accordance with existing company policies and procedures. Perform any other tasks/duties as assigned by management. Education Requirements and Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. High School or GED diploma required. Associate's degree or equivalent years of experience preferred. Experience working in a Quality role within a cGMP manufacturing environment required. Knowledge and understanding of quality assurance principles, controls and interactions between Quality Systems; FDA guidance, ICH, PIC/S, etc. Strong attention to detail, adherence to SOPs. Ability to work effectively in a collaborative environment. Ability to effectively work under dynamic constraints, with success in managing multiple activities concurrently and producing outstanding results. Strong organizational, interpersonal and communication skills (oral and written). Written skills must be audit-level appropriate for non-routine or complex issues. PC Skills Required (MS Word, Excel). Ability to work overtime as needed. Physical Environment and Requirements Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves. PPE is essential for the health and safety of employees. Expected Salary Range: $70,100 - $85,000 The salary range, displayed is the minimum and maximum annual salary range of compensation for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate's qualifications, education, knowledge, skills and experience. American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide range of other benefits. American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. Applicants have rights under Federal Employment Laws. FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov) Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf Alert: We're aware of individuals impersonating our staff to target job seekers. Please note: All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address. Our recruiting process includes multiple in person and/or video interviews and assessments. If you are unsure about the legitimacy of a message, contact John Rossini at jrossini@americanregent.com before responding. We never request payment, bank information, or personal financial details during our offer process. Your security is important to us, and we encourage you to stay vigilant when job searching. American Regent Inc. endeavors to make https://careers.americanregent.com/ accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email hrtalentacquisition@americanregent.com.

Posted 30+ days ago

Eli Lilly and Company logo
Eli Lilly and CompanyLebanon, TN

$65,250 - $169,400 / year

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Lilly is currently constructing a cutting-edge facility for the manufacture of new modalities including Gene Therapy. At Lebanon, Indiana, this facility will be Lilly's most technically advanced manufacturing site focused on the delivery of the next wave of innovative products at Lilly. It will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety and quality, and process performance. This is a unique opportunity to be a part of the team for the startup of a greenfield manufacturing site, and the successful candidate will help to design, commission, start up, and maintain the facility for both clinical and commercial supply. This is an exciting opportunity to help build a state-of-the-art facility and Quality System from the ground up. The Lebanon Advanced Therapies (LP2) Quality Assurance External Manufacturing Representative is responsible for demonstrating leadership, teamwork, and quality/regulatory knowledge to provide effective quality oversight of contract manufacturers and alliance partners. This oversight covers the process steps of selection, pre-validation/validation, ongoing operations and termination. LP2 External Manufacturing Quality Assurance maintains communication and working relationships with alliance partners, contract manufacturers, and internal customers. The External Manufacturing QA Representative manages daily contract manufacturing activities and ensures adherence to Lilly GQS and cGMPs through deviation investigations, change control, documentation management, validations, and other relevant responsibilities. This position also supports inspection readiness, product launches, and is accountable for batch disposition, confirming all batches comply with specifications and regulatory requirements. Responsibilities: Serve as a liaison between CMs and Lilly, providing quality oversight and serving as the initial point of contact for all quality-related issues Escalate quality issues at CMs to Lilly QA management. Assist in the establishment and revisions of Quality Agreements with affiliates and customers Ensure compliance to Quality Agreements and Manufacturing Responsibilities Documents (MRDs) Evaluate and disposition drug substance, drug product, and packaging batches ensuring that documented checks have been completed for the Certificates of Testing, Certificates of Environmental Monitoring (where applicable), deviations, changes and batch documentation Provide quality support of manufacturing operations with holistic review of key activities associated with or impacting the manufacturing processes. Maintain awareness of external regulatory agency findings which individually or collectively reference the quality of the product Review and approve documents including, but not limited to, procedures, master production records, change control proposals, deviations, equipment qualifications, analytical methods and computerized system validations Provide onsite support of manufacturing operations as required Participate in regulatory inspection preparations with CMs. Provide on-site support during inspections Participate in APR activities Participate in Post Launch Optimization Teams (PLOT) Basic Requirements: Bachelor's degree in relevant field (preference for scientific or engineering field) 3+ years working in the pharmaceutical manufacturing industry in Quality Assurance roles Previous experience providing Quality Assurance oversight of contract manufacturers Additional Preferences: Demonstrated knowledge and use of US, EU, Japan and other regulations in the area of pharmaceutical manufacturing ASQ Certified Previous facility or area start up experience Previous experience with gene therapy drug substance processes such as equipment prep, virus prep/banking, inoculation, purification, and/or drug product manufacturing processes such as formulation, filling/visual inspection, and packaging Previous experience with Manufacturing Execution Systems. Demonstrated ability to communicate with and influence cross-functional teams including good oral and written communication skills Demonstrated strong problem solving and decision-making skills Previous technical writing experience Technical aptitude and ability to train and mentor others Additional Information: Ability to work 8-12 hour shifts on Monday-Friday in the Lebanon, IN office Position may require travel (10-25%) Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $65,250 - $169,400 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

Posted 3 weeks ago

Claire's Accessories logo
Claire's AccessoriesChicago, IL

$67,704 - $90,272 / year

About the Role The Chemical Quality Assurance (QA) Specialist, Beauty supports product quality, safety, and compliance across our business and partnerships. This role will support the merchant teams and suppliers to assist in documentation review and supplier quality management to ensure all beauty and personal care products meet regulatory and brand standards. Reporting to the Manager, Quality Assurance, this position plays a key role in maintaining product integrity and supporting Claire's business growth through consistent quality excellence. Key Responsibilities: Supplier Quality Management: Partner with sourcing and merchant teams to evaluate suppliers and maintain quality standards. Oversee supplier documentation, audits, and continuous improvement actions. Documentation & Regulatory Support: Maintain technical files, labeling accuracy, and compliance documentation. Support regulatory submissions and prepare quality summaries for new launches. Quality Issue Investigation: Analyze customer feedback and product trends to identify and resolve quality issues. Lead root cause analysis and manage corrective and preventive actions (CAPA). Cross-Functional Collaboration: Work with internal teams and third-party labs to align on quality, testing, and sustainability goals. Support clean beauty and product safety initiatives across categories. Other duties as assigned Education: Bachelor of Science or Engineering or a related field 5-10 years of experience in cosmetics or personal care QA/QC Experience in a multi-brand or retailer-led QA organization. Familiarity with QA testing workflows. Experience in responding to regulatory agencies such as FDA, Customs and CPSC. Knowledge of packaging materials compatibility and sustainability testing. Certification or coursework in Cosmetic Product Safety Assessment or GMP (ISO 22716) Strong understanding of cosmetic formulation, labeling, and regulatory standards. Familiar with FDA MoCRA, Health Canada and Prop 65. Experience reviewing RSLs, MSDS, CPSR, COA, and microbiological testing reports. Excellent organizational skills and ability to manage multiple workstreams across partners. Strong written and verbal communication, comfortable interacting with partners. Proficient in Microsoft Excel, SharePoint, and compliance databases.2-3 years of experience in retail operations, wholesale/franchise coordination, planning, finance, merchandising support, or similar. Compensation Range: $67,704.00 - $90,272.00 Claire's is committed to adhering to all applicable company policies and federal, state, and local laws and regulations. All positions will be compensated at or above the legally mandated minimum wage for the location in which work is performed. The final compensation will be determined by various factors such as relevant work experience, education, certifications, skills, and geographic location. Benefits for full-time employees included medical, dental, and vision insurance, voluntary welfare plans, bonus plan eligibility, 401(k) match, vacation time, sick time* and paid leave. Benefits for part-time employees included voluntary welfare plans, 401(k) match, vacation time, sick time* and paid leave in required states. Sick Time: For the State of Washington, all employees will accrue paid sick time at the rate of 1 hour for every 30 hours worked. Claire's is an equal opportunity employer committed to diversity, equity, and inclusion and we encourage applications from members of all underrepresented groups, including those with disabilities. We will accommodate applicants' needs, upon request, throughout all stages of the recruitment process. Please inform us of the accommodation(s) that you may require. Information received relating to accommodation will be addressed confidentially. To request accommodation, please email Benefits@claires.com. Only messages sent for this purpose will be considered.

Posted 3 weeks ago

PJM Search logo
PJM SearchAudubon, NJ
Flexible Work Arrangement: Hybrid The Sr. QA Analyst role reports to the Manager of the Quality Management ("QM") department. This position will be responsible for creating and implementing test approaches and test plans to test application enhancements and changes against documented business requirements and user stories, in a manner which results in a high quality solution meeting the functional and non-functional requirements of the user base. The Sr. QA Analyst provides testing services and test leadership to project teams and departments at PJM and guides other testers and business users through the testing process. A key aspect of this role is the actual performance of testing in the PJM application and system environments. Additionally, this role is responsible for guiding and implementing the overall methodology practices PJM uses within the organization. Essential Functions: Understand and effectively communicate and customize PJM SDLC processes, methods and practices for project teams ranging from small enhancement projects to large, multi-million dollar implementations. Create, develop and implement innovative approaches for quality assurance and testing within a technology environment commensurate with PJM SDLC practices, policies and procedures, and good business judgment. Direct the development of quality assurance benchmarks and metrics to assure the ongoing effectiveness of relevant processes and systems within the division. Passionately maintain exceptional customer focus. Maintain an inspired culture that is time-based and centered on integrity and customer focus. Actively participate in the development of the department and division strategy as it relates to the quality assurance and testing aspects of any initiative at PJM. Participate as required in the annual expense and capital budget process for the department and division. Provide training and mentoring through multiple avenues including Guild meetings, one-on-one sessions, and project team training sessions. Develop training materials and related documentation to support process implementation. Perform Testing duties as assigned including: Understand project priorities and ensure the areas of functionality are being tested appropriately. Develop or lead the development of testing objectives and related control objectives. Develop or lead the development of appropriate test strategies and approaches. Direct the work of infrastructure and database teams to identify requirements and availability of all necessary test environments. Ensure support for all necessary testing for a given application, including product (functional) test, regression test, integration test, and user acceptance test. Assure that test data, scripts, documentation and expected results for all tests are maintained as appropriate. Assume a lead role in projects, including contributing to the development of project plans related to quality assurance and the testing function. Take a lead role with the department manager and other key stakeholders in the evaluation, selection and implementation of appropriate testing tools for specific testing applications (such as performance or automation testing) when required. Demonstrate ability to work independently and to train, guide, or assist others in the completion of assignments. Build and develop strong relationships with divisional business area clients by providing superior customer support as demonstrated by clearly owning, resolving and communicating issues and problems; being responsive to needs, requirements, and deadlines; and generally promoting goodwill in a professional and trust-building manner. Characteristics & Qualifications: Required: Bachelor's Degree in Computer Science or equivalent work experience Ability to produce high-quality work products with attention to detail Ability to communicate effectively in a team environment Experience in quantitative and qualitative analysis Experience using verbal and written communications skills Ability to use Microsoft Office Suite (MS-Word, MS-Excel and MS-PowerPoint) Preferred: MBA, Business Administration Experience with PJM operations, markets, and planning functions Experience supporting any of PJM Committees International Software Testing Qualifications Board Certification (ISTQB)

Posted 3 weeks ago

SS&C Technologies logo
SS&C TechnologiesWindsor, CT

$150,000 - $175,000 / year

As a leading financial services and healthcare technology company based on revenue, SS&C is headquartered in Windsor, Connecticut, and has 27,000+ employees in 35 countries. Some 20,000 financial services and healthcare organizations, from the world's largest companies to small and mid-market firms, rely on SS&C for expertise, scale, and technology. Job Description Job Title: Director of QA Locations: Boston, MA or Windsor, CT | Hybrid Get To Know Us: We are a fast-paced, dynamic team, who are leaders in technology and responsible for developing, maintaining, implementing, and expanding our next-generation platform for insurance companies. Singularity is a cloud-based, AI-powered platform for insurers and investment managers that provides integrated accounting, operational processing, and advanced analytics for all asset types. Why You Will Love It Here! Flexibility: Hybrid Work Model and Business Casual Dress Code, including jeans Your Future: 401 (k) Matching Program, Professional Development Reimbursement Work/Life Balance: Flexible Personal/Vacation Time Off, Sick Leave, Paid Holidays Your Wellbeing: Medical, Dental, Vision, Employee Assistance Program, Parental Leave Wide Ranging Perspectives: Committed to Celebrating the Variety of Backgrounds, Talents, and Experiences of Our Employees Training: Hands-On, Team-Customized, including SS&C University Extra Perks: Discounts on fitness clubs, travel, and more! What You Will Get To Do: The Director of QA is responsible for defining and executing a consistent and repeatable process for full product testing, deployment, and release for Insurance software solutions. The Director must have strong leadership and planning skills and be able to manage both large and small projects through an iterative lifecycle model. Ensures that products meet end-user functional and design requirements as well as performance and scale expectations through the execution of software quality tests. Defines and executes integration, performance, regression, and/or acceptance testing. Develops and supports the test automation environment for executing software quality tests. Leader with broad operational or functional responsibilities who participates with other senior leaders or executives to establish and ensure the achievement of strategic plans and objectives. Demonstrates in-depth company knowledge, specialized skills, and influence to solve critical and complex issues. Participates in the development and administration of broad-scope programs and projects that have a significant impact on operational or functional success. The Director will manage a team across multiple locations and will be responsible for defining and executing the test strategy, maintaining a build environment throughout the iterative development cycle, and building the final release of the product to deliver to market. The incumbent for this role will: Define and maintain project plans to manage delivery schedule, resource management, task tracking, and status reporting through testing and release phases of projects Define and execute a consistent, repeatable process for QA Maintain an efficient, high-quality library of scripts for automated testing Deliver a clear release-to-market certificate for all product releases Maintain reliable infrastructure to support source control, build, and release environment Deliver a reliable and repeatable deployment model for all products Manage day-to-day task assignment and team member workload Manage progress and status for a cross-functional team across multiple projects Establish SMART goals and career development for team members and review/reset as necessary What You Will Bring: Candidates must have led product QA organizations with oversight over the parts of the software development process that involve QA testing and release readiness, and have experience with SaaS software applications in the financial services sector. 10-15 years of experience in the financial industry 10 years in a QA leadership position A candidate should have extensive experience implementing the testing and QA approach as applied to a business or a product Candidate must have planning and presentation skills The Candidate must have strong leadership abilities and the ability to provide direction Education: B.A. or B.S. required Thank you for your interest in SS&C! If applicable, to further explore this opportunity, please apply directly with us through our Careers page on our corporate website @ www.ssctech.com/careers. Salary range for the Position is expected between $150,000.00 and $175,000.00. The successful candidate may be eligible for an annual discretionary incentive compensation award. #LI-DS3 #LI-HYBRID Unless explicitly requested or approached by SS&C Technologies, Inc. or any of its affiliated companies, the company will not accept unsolicited resumes from headhunters, recruitment agencies, or fee-based recruitment services. SS&C offers excellent benefits including health, dental, 401k plan, tuition and professional development reimbursement plan. SS&C Technologies is an Equal Employment Opportunity employer and does not discriminate against any applicant for employment or employee on the basis of race, color, religious creed, gender, age, marital status, sexual orientation, national origin, disability, veteran status or any other classification protected by applicable discrimination laws.

Posted 1 week ago

Bristol Myers Squibb logo
Bristol Myers SquibbDevens, MA
Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us. At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here at BMS with our Cell Therapy team. The Quality Assurance Shop Floor team is responsible for 24x7 Quality collaboration and oversight of site operations, including but not limited to Manufacturing, Quality Control laboratories, and Warehouse Operations. The Senior Specialist, Quality Assurance Shop Floor, Cell Therapy position will oversee and partner with operational areas to ensure GxP compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP. In the capacity of QA Shop Floor, the Senior Specialist shall serve as one of the Quality Representatives interacting with Manufacturing, Supply Chain, Quality Control and other supporting functions. The Senior Specialist, QA Shop Floor, is accountable to own quality decision making as it relates to unexpected events on the production floor, deviation triage and determination. Participation in cross-functional triage meetings. They own; review or quality approve GxP records including but not limited to procedures, batch records, or deviations. Additionally, the incumbent shall support deviation approval, alarm approval, and other Quality System Records as requested by management. Effective communication, critical thinking, and a thirst for knowledge are foundational skills for members of the Shop Floor Quality Assurance team to succeed. Shifts Available: A1 & B1- 6am- 6pm, rotational schedule including holidays and weekends Responsibilities: Provide Quality oversight to Manufacturing/QC/Warehouse/ Packout operations. Identify departures from approved procedures & respond to complex issues independently & escalate critical issues to management. May perform and document operational verification per approved procedures. Develops, reviews and/ or approves temporary and non routine procedure for event response. Observe manufacturing operations and identify departures from clean room behaviors and aseptic techniques. Coordinate and lead area walkthroughs to identify quality issues. Negotiate remediations and drive alignment of implementation plans. Own actions for departmental programs and propose improvements to programs. Communicate and resolve discrepancies independently and escalate as required. Author, review, and approve procedural documents. Maintain compliance with assigned learning plan. Provide guidance and training for QA personnel. May own training curriculum and content. Independently assess discrepancies for entry into quality system and approve records as applicable. Lead meetings and represent function at cross functional meetings. Share data/knowledge within and across team. Build & maintain strong relationships with partner functions. May prioritize and assign tasks for the team. Observe operations occurring on the floor and proactively identify risks and drive improvements. Establish and maintain key performance indicators and standard work databases in alignment with departmental and product supply goals. Able to influence others based on time and task commitments, organize/run meetings. Obtain access to, and develop as an SME for, various electronic systems utilized by Quality Assurance Shop Floor (BMSDocs, CELabs, MES, SAP, ValG, DeltaV, Maximo, Infinity, etc.). Should be familiar with GMP-related systems including Quality Risk Management, Document and Data Governance, Monitoring and Reporting. Knowledge and Skills: Ability to research, understand, interpret and apply internal SOP's, policies and regulatory guidelines. Proficient computer skills with knowledge of digital tools such as MS Office, etc. and ability to learn and work with new software applications. Ability to interpret data & results, understand complex problems with multiple variables, and articulate practical solutions. Excellent written and verbal skills and ability to present technical data effectively based on target audience. Ability to work in a fast-paced team environment and lead peers through changing priorities. Detail oriented and task focused with ability to meet deadlines and support work prioritization. Ability to negotiate and influence to craft mutually beneficial solutions. Ability to motivate and foster a positive team environment. Exhibit strong decision-making ability and think creatively while maintaining compliance and quality. Demonstrated experience with quality management systems for handling of records such as change control, product complaints, deviations, investigations, and CAPA management. Demonstrated ability to learn and work with analytical computer/digital tools like Microsoft Power Automate, Smartsheet, Tableau, etc. Demonstrated experience with quality management systems Demonstrated experience in GxP electronic systems such as Quality Management Systems (QMS); Manufacturing Execution Systems (MES) for electronic batch records; Enterprise Resource Planning (ERP) such as SAP; laboratory information management systems; or electronic logbooks/forms. Basic Requirements: Bachelor's degree in STEM field preferred. High school diploma/ Associates degree with equivalent combination of education and work experience may be considered. 4+ years of relevant cGMP experience, preferably with 1+ year of manufacturing site experience. Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred. BMSCART #LI-ONSITE GPS_2025 If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Compensation Overview: Devens- MA - US: $89,780 - $108,789 The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/ . Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include: Health Coverage: Medical, pharmacy, dental, and vision care. Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP). Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support. Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown. Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as "Transforming patients' lives through science ", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. Supporting People with Disabilities BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. Candidate Rights BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/ Data Protection We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection . Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley. R1596913 :

Posted 30+ days ago

Hewlett Packard Enterprise logo
Hewlett Packard EnterpriseSunnyvale, CA

$106,000 - $243,000 / year

QA/Automation Engineer This role has been designed as 'Hybrid' with an expectation that you will work on average 2 days per week from an HPE office. Who We Are: Hewlett Packard Enterprise is the global edge-to-cloud company advancing the way people live and work. We help companies connect, protect, analyze, and act on their data and applications wherever they live, from edge to cloud, so they can turn insights into outcomes at the speed required to thrive in today's complex world. Our culture thrives on finding new and better ways to accelerate what's next. We know varied backgrounds are valued and succeed here. We have the flexibility to manage our work and personal needs. We make bold moves, together, and are a force for good. If you are looking to stretch and grow your career our culture will embrace you. Open up opportunities with HPE. Job Description: We are looking for a detail-oriented and proactive QA/Automation Engineer to validate and automate testing for Mist Systems' Network Access Control (NAC) product. You will design and execute both manual and automated test cases, ensure seamless integration with Juniper products and third-party identity services, and help maintain high product quality through robust automation. Key Responsibilities: Design, develop, and execute manual and automated test cases for NAC components (policy enforcement, device onboarding, posture checks, MDM integration, etc.) Collaborate with Product Managers and Developers to create comprehensive test plans Validate integrations with Mist Dashboard, Juniper switches, access points, and external identity services (Azure AD, Okta, RADIUS) Automate end-to-end workflows using Python, REST APIs, and relevant frameworks Simulate network conditions using virtual labs or physical testbeds Maintain CI/CD pipelines for automated test execution Perform regression, performance, scalability, and security testing Analyze logs, debug issues, and document detailed bug reports Support debugging of live production customer issues Required Qualifications: Bachelor's degree in Computer Science or related field, Master's degree preferred 5+ years in QA or Automation engineering (networking or security products preferred) Strong networking fundamentals (TCP/IP, VLANs, DHCP, RADIUS, 802.1X, NAC) Automation experience with REST APIs, Python, and related frameworks Cloud-native platform and microservices testing experience Proficiency with Wireshark, Postman, Jenkins, Docker, and Git Excellent troubleshooting, communication, and documentation skills Preferred Qualifications: Experience with Mist Systems, Juniper, or other NAC solutions (Cisco ISE, Aruba ClearPass, FortiNAC) Knowledge of SAML/OAuth2, Azure AD, Okta, Zero Trust, and endpoint posture checks Familiarity with test management/reporting tools (e.g., TestRail) Additional Skills: Cloud Architectures, Cross Domain Knowledge, Design Thinking, Development Fundamentals, DevOps, Distributed Computing, Microservices Fluency, Full Stack Development, Security-First Mindset, Solutions Design, Testing & Automation, User Experience (UX) What We Can Offer You: Health & Wellbeing We strive to provide our team members and their loved ones with a comprehensive suite of benefits that supports their physical, financial and emotional wellbeing. Personal & Professional Development We also invest in your career because the better you are, the better we all are. We have specific programs catered to helping you reach any career goals you have - whether you want to become a knowledge expert in your field or apply your skills to another division. Unconditional Inclusion We are unconditionally inclusive in the way we work and celebrate individual uniqueness. We know varied backgrounds are valued and succeed here. We have the flexibility to manage our work and personal needs. We make bold moves, together, and are a force for good. Let's Stay Connected: Follow @HPECareers on Instagram to see the latest on people, culture and tech at HPE. #unitedstates #networking Job: Engineering Job Level: TCP_03 States with Pay Range Requirement The expected salary/wage range for a U.S.-based hire filling this position is provided below. Actual offer may vary from this range based upon geographic location, work experience, education/training, and/or skill level. If this is a sales role, then the listed salary range reflects combined base salary and target-level sales compensation pay. If this is a non-sales role, then the listed salary range reflects base salary only. Variable incentives may also be offered. Information about employee benefits offered can be found at https://myhperewards.com/main/new-hire-enrollment.html . USD Annual Salary: $106,000.00 - $243,000.00 HPE is an Equal Employment Opportunity/ Veterans/Disabled/LGBT employer. We do not discriminate on the basis of race, gender, or any other protected category, and all decisions we make are made on the basis of qualifications, merit, and business need. Our goal is to be one global team that is representative of our customers, in an inclusive environment where we can continue to innovate and grow together. Please click here: Equal Employment Opportunity. Hewlett Packard Enterprise is EEO Protected Veteran/ Individual with Disabilities. HPE will comply with all applicable laws related to employer use of arrest and conviction records, including laws requiring employers to consider for employment qualified applicants with criminal histories. No Fees Notice & Recruitment Fraud Disclaimer It has come to HPE's attention that there has been an increase in recruitment fraud whereby scammer impersonate HPE or HPE-authorized recruiting agencies and offer fake employment opportunities to candidates. These scammers often seek to obtain personal information or money from candidates. Please note that Hewlett Packard Enterprise (HPE), its direct and indirect subsidiaries and affiliated companies, and its authorized recruitment agencies/vendors will never charge any candidate a registration fee, hiring fee, or any other fee in connection with its recruitment and hiring process. The credentials of any hiring agency that claims to be working with HPE for recruitment of talent should be verified by candidates and candidates shall be solely responsible to conduct such verification. Any candidate/individual who relies on the erroneous representations made by fraudulent employment agencies does so at their own risk, and HPE disclaims liability for any damages or claims that may result from any such communication.

Posted 30+ days ago

I logo
IlitchDetroit, MI
Build a Bigger, Better, Bolder Future Imagine working for a company that measures its success based off the growth of its colleagues, a company that invests in its future by investing in you. Little Caesars is a company where our colleagues make an impact. Your Mission: Lead and manage the development of ingredients, focusing on the cheese category, to enable company's strategy and growth plans for international markets. This includes supplier development around the globe as well as managing quality assurance policies and initiatives. Development responsibilities include formulations, scale up production runs, testing and launching of ingredients. The position is based within the corporate quality assurance team located in Detroit, MI and reports to the Director of Global Food Safety and Quality Assurance. How You'll Make an Impact: Make an immediate impact by being the subject matter expert in Dairy Science and processing technology with an emphasis in cheese. Use your knowledge of technical application of food science and processing technology to enhance pizza ingredients. Collaborates with R&D, QA, Supply Chain and Suppliers to develop cheese and pizza ingredients to achieve defined end product attributes. Responsible for supplier product development; testing, validating product performance in restaurants and through shelf life, scaling/commercializing, and finalizing specifications. Manages product development projects, collaborating with cross-functional partners such as Supply Chain, Marketing, Operations, and Training to meet timelines. Seeks methods to educate and improve knowledge of new technologies, manufacturing processes, supplier capabilities, and ingredient technologies. Proactively reviews food law and regulations to identify business impact and opportunities to adapt ingredients. Creates, implements and communicates updated policies, procedures and programs that ensure product safety and quality. Creates, updates and communicates product specifications and issues changes. Executes quality assurance programs and policies for product, suppliers and distributors. Identifies and resolves supplier food safety and quality issues. Provides technical support and acts as a liaison with the quality control function at suppliers to develop and ensure controls are developed, executed and maintained. Investigates and resolves customer complaints Assists suppliers with LC ingredient manufacturing and problem resolution. Responsible for corporate product recalls and retrievals and maintaining appropriate documentation. Administers mock recalls to distribution centers. Coordinates sanitation audits, lab testing and samples from distribution centers. Assists leadership in policy creation for vendors, vendor evaluations and audits Maintains approved manufacturer list for regional vendors. Performs other duties as requested by Supervisor. May be responsible for management of others, including hiring and performance management. Who You Are: Bachelor's degree in Food Science, Biology, Chemistry or related discipline. Seven (7) to Ten Years (10) in Quality Assurance and R&D in the food industry. Minimum two (2) years of experience in food manufacturing required. Excellent interpersonal and teamwork skills and ability to work cross-functionally with individuals and teams, internally and externally. Demonstrated ability to build and maintain relationships with internal and external colleagues, vendors and suppliers Demonstrated ability to prioritize and manage multiple, complex projects and initiatives simultaneously with a results-oriented approach. Strong verbal, written and presentation communication skills with ability to communicate technical information to a wide variety of audiences and with all levels of the organization. Ability to communicate effectively with franchisees, vendors and other departments, often communicating complex technical data to a variety of audiences. Evidence of the ability to establish, document, update and track quality metrics, preferable through standardized and accepted process control procedures. Experience in a previous position requiring accuracy, attention to detail and documentation of issues, resolutions and policy changes. Excellent problem-solving and decision-making skills. Good interpersonal skills and ability to resolve conflicting points of view. Sensory abilities for product evaluation. HACCP certification and foodservice sanitation certification. Ability to travel within the US and Internationally 30% - 50% Computer proficiency (Microsoft Office, database, internet and documentation software required. Knowledge/experience in dairy/cheese products and manufacturing processes of the dairy and cheese products is preferred. Knowledge/experience in pizza/QSR/food service, pizza ingredients, and restaurant equipment is preferred. Where You'll Work: Position requires working in both an office and test kitchen environment. Position requires work in manufacturing plants, evaluating supplier capabilities and ensuring adherence to production run requirements. Position requires field work in LC restaurants, supplier kitchens, research facilities, and non-traditional venues. Position will require moderate (30% - 50%) international travel via a variety of transportation modes Ability to lift, push, or pull up to forty (40) pounds of weight in order to transport food materials (bulk ingredients) and/or equipment. All items listed above are illustrative and not comprehensive. They are not contractual in nature and are subject to change at the discretion of Little Caesars Enterprises Inc. Little Caesar Enterprises, Inc. is an Equal Employment Opportunity employer. All qualified applicants will receive consideration for employment without regards to that individual's race, color, religion or creed, national origin or ancestry, sex (including pregnancy), sexual orientation, gender identity, age, physical or mental disability, veteran status, genetic information, ethnicity, citizenship, or any other characteristic protected by law. The Company will strive to provide reasonable accommodations to permit qualified applicants who have a need for an accommodation to participate in the hiring process (e.g., accommodations for a job interview) if so requested. This company participates in E-Verify. Click on any of the links below to view or print the full poster. E-Verify and Right to Work. PRIVACY POLICY

Posted 30+ days ago

CSSI, Inc. logo
CSSI, Inc.College Park, GA
Responsibilities: Review and validation of Mandatory Occurrence Reports (MORs). Investigates surface incidents including runway incursions, vehicle/pedestrian deviations, pilot deviations, ATC loss of separation. As appropriate conducts interviews of pilots. Completes required preliminary reporting forms, i.e., FAA Form 8020-17, for various incidents. Creates replays and retrieves voice recordings to assist in investigation, research, and review of incidents. As requested by the QA Manager prepares reports to support and communicate program status. Communicates with FAA Facilities and other program offices. Purpose of communication is to provide assistance to field facilities concerning QA/QC and Runway Safety issues and share information with other program offices. Contacts field facilities to request information that cannot be obtained through other methods. Minimum Qualifications: Bachelor's degree in math, engineering, or science plus a minimum of 15 years ATC experience in a LVL 8 or higher FAA/military equivalent ATC facility. Educational Requirement: In lieu of an applicable bachelor's degree eight (8) years of relevant experience may be substituted Candidate must able to work out of the Eastern Service Area (College Park, GA office) on a full time basis. Desired Qualifications: Experience as a QA/QC specialist or manager in a field ATC facility, District, Service Center/Service Area office, or at FAA Headquarters About CSSI: CSSI, LLC., has 30 years of experience working in complex, dynamic, safety critical systems supporting both government and commercial clients to address their toughest challenges, with efficient and low-risk solutions. Our collaborative work has improved the safety of transportation related human and systems infrastructure, increased the efficiency of the National Airspace System (NAS), and facilitated the modernization of both NAS and DoD systems and capabilities. Founded in 1990 and headquartered in Washington, D.C., CSSI employs nearly 200 employees throughout the country, helping customers across the United States and globally understand and implement the solutions to their biggest obstacles. For more information on CSSI, please visit www.cssiinc.com.

Posted 30+ days ago

KBI Biopharma logo

Senior QA Specialist, Client Support

KBI BiopharmaDurham, NC

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Job Description

At KBI Biopharma, we are advancing science and accelerating breakthroughs. As a global leader in biopharmaceutical development and manufacturing, we empower life science companies to bring new medicines and vaccines to the world faster. Explore your potential at KBI, where innovation meets impact.

Position Summary:

The Quality Systems team is responsible for establishing and continuously improving the Quality Management System (QMS) that supports the site and Global Compliance activities ensuring systems and business processes are robust, effective, and efficient to comply with required regulations, policies, and guidelines governing the manufacture and holding of materials for our company. The Quality Systems departments goal is support of the site teams to achieve a culture of ongoing regulatory readiness and sustained compliance that delivers safe, pure and effect materials to our clinical and commercial clients.

The Senior Quality Assurance Specialist- Client Support is a key Individual Contributor and client projects leader on the Quality Systems team, serving as the Quality-to-Quality client liaison. The incumbent collaborates closely with counterparts throughout the Quality team, supporting processes required to ensure compliance with internal quality documents, regulatory requirements, and cGMP for early and late phase clinical and commercial manufacturing. The incumbent will be responsible for providing support for such activities as product release, deviation, complaint and supplier investigation and closure and facilitating associated collaborations. Additionally, the incumbent will support the compilation, analyzing and reporting of associated metrics. The role requires routine interactions with all functions supporting the external network, including interaction with functions across the company's global network.

This role is an onsite hybrid role, working a schedule Monday through Friday between the hours of 8:00 am- 5:00 pm.

Responsibilities:

  • Serves as QA facilitator for the Quality aspect of client projects: accountable as the Quality lead, actions coordinator and delegate for the site client project team, joint QA and related meetings.
  • Provides interface between KBI Quality and client regarding batch status, Quality metrics, and Quality issues impacting batch disposition and disposition timeline.
  • Communicates client concerns to KBI teams; facilitates discussions as necessary to resolve client issues. Escalates issues to leadership as needed. Interfaces with the PMO team to ensure Quality topics are addressed.
  • Supports Batch disposition, fully executing the disposition process as needed.
  • Supports audit / inspection readiness of the site. Participates in regulatory and other quality/compliance report-outs; reviews client audit outcomes to ensure appropriate corrective actions are implemented as assigned.
  • Works with Global Compliance to support Client Audits
  • Supports Deviation Management activities by participating in investigational meetings, activities, writing and approving investigation as needed.
  • Assists with compiling, reviewing/ approving Quality Systems and Compliance documentation and reports.
  • Demonstrates knowledge of Quality Systems and functions supporting drug or related FDA governed manufacturing obtained from professional Quality roles. Includes a balance of, from such areas as Supplier Quality Assurance, Compliance, Audits/Inspections, Shop Floor Support, Batch / Material release, Quality document control, review and approval, Validation, QC, Deviations, audit support.
  • Demonstrated ability to keep Project Leads, such as PMs and team members, informed of the status of assigned work. Ability to determine where escalation is necessary. Capability of being flexible as required tasks change and maintain productivity.

Requirements:

  • BS/BA Degree in Science or Engineering relevant to the pharmaceutical / Life Science or related industries AS/AA acceptable with 5-7 years of relevant experience as described below.
  • Minimum 5 years prior experience in the Pharmaceutical/Biotechnology industry with a thorough knowledge of Quality Systems, Quality Assurance, and Quality Operations including solid knowledge of global GMP Quality and Regulatory requirements.
  • Minimum of 2 years of previous experience in QA and in a Client-Facing QA or Project Management role
  • Ability to communicate in customer-facing forums to progress issues and obtain positive results.
  • Ability to work professionally with others and facilitate positive interdepartmental interactions with a diverse group of people. Includes ability to navigate conflict to achieve deliverables and drive to targeted outcomes, as well as to resolve differing perspectives with effective negotiation.
  • Listens and is attentive to others' ideas and contributions.
  • Demonstrated ability to be a strong, dependable team-player, yet effective at advancing assignments and projects independently. Voluntarily communicates needs and suggestions clearly and effectively.
  • Demonstrated strong attention to detail and effective investigation, problem solving, and organizational skills. Ability to properly prioritize tasks and manage time effectively. Proactive approach to drive tasks to completion.
  • Excellent written and verbal communication skills.
  • Ability to read, write, and proofread technical documents, investigations, regulatory documents, etc.
  • Ability to compile and analyze data and information from multiple sources
  • Ability to perform basic calculations and data assessment, simple statistics, graphing, plotting data
  • Minimum intermediate proficiency with of Microsoft Office Excel, Word, PowerPoint (Microsoft365).
  • Intermediate proficiency with ERP and QMS systems required, such as SAP, TrackWise, and LIMS p
  • Ability to sit for extended periods of time.
  • Ability to work on site in a manufacturing environment periodically.

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.

I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.

I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.

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