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Early Warning Services, LLCChicago, IL
At Early Warning, we've powered and protected the U.S. financial system for over thirty years with cutting-edge solutions like Zelle, Paze℠, and so much more. As a trusted name in payments, we partner with thousands of institutions to increase access to financial services and protect transactions for hundreds of millions of consumers and small businesses. Positions located in Scottsdale, San Francisco, Chicago, or New York follow a hybrid work model to allow for a more collaborative working environment. Candidates responding to this posting must independently possess the eligibility to work in the United States, for any employer, at the date of hire. This position is ineligible for employment Visa sponsorship. Overall Purpose This position will lead the Zelle Engineering organization. Zelle's growth since launch in 2017 has been astronomical, with many enhancements along the way to keep the system stable and performant - as we look forward for the next decade at the growth and capabilities of the network there are opportunities to evolve key parts of the network's tech stack to accomplish everything from orders of magnitude, additional growth in use, in addition to improvements like easier Financial Institution integration opportunities. We are starting a significant multi-year journey of maturing core components of Zelle into a Cloud-based environment and this leader will need to have extensive experience in this space. This position will be leading these efforts in collaboration with internal stakeholders as well as potentially external (FI) partners to drive that next decade of vision for Zelle. Essential Functions Able to understand and juggle multi-faceted roadmap requirements covering Product asks, re-platforming needs, maintenance and security work across the Zelle Engineering organization to deliver on success in many areas. Utilizes knowledge and lessons-learned from building enterprise-scale systems in the cloud to help drive best practices, architectures and technology decisions inside the Zelle organization. Collaborates closely with Engineering leaders, Architecture and potentially external collaboration partners (FIs) that may be engaged with us on key efforts over the years. Maintains a very high bar for execution and excellence in the Engineering team, fostering leadership and executive presence throughout; can 'coach up' team members and leaders for a highly engaged, high-performing team, and hire top talent into the team to support these large-scale efforts. Identifies opportunities to ship value to Production quickly and in incremental chunks to avoid "big bang" delivery; complex environments benefit from incremental delivery. Builds and delivers well-considered Zelle scaling solutions via strong relationships with key stakeholders in the Data, Architecture and Operations organizations. Ensures software development follows effective quality guidelines and best practices in line with the rest of the Engineering organization. Ensures accurate/reliable information is provided within company standards including all service level agreements, and audit regulations. Ensures solutions are built following our Engineering best practices (e.g., Quality, CI/CD, etc.) Keeps executive-level management informed of department progress and problems. Complies with all security policies and procedures, to ensure that the highest level of system and data confidentiality, integrity and availability is maintained. Support the company's commitment to risk management and protecting the integrity and confidentiality of systems and data. The above job description is a summary of job responsibilities and is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow instructions and perform tasks and other duties as assigned by their supervisor. Minimum Qualifications Education or experience typically obtained through completion of a Bachelor's degree in Computer Information Systems, Information Technology, Information Systems, Computer Science or equivalent professional experience. Minimum 15 or more years of software engineering experience Minimum 10 years or more experience in leading efforts or processes in a Technology organization. Minimum 5 or more years of software engineering experience dealing with large scale systems in the cloud. Minimum 5 or more years of experience implementing application solutions/ services in Cloud using Containerization, CI/CD, Automated testing and in compliance security guidelines. Minimum 10 years or more of experience in managing an Engineering organization. Demonstrated ability to provide technical leadership through large-scale system designs, upgrades, and releases. Superior leadership and management skills together with strong business acumen. Demonstrated ability to mentor and energize people showcasing technical and leadership skills. Demonstrated experience with state- of- the- art technology, architecture and design concepts, open-source operating systems, database systems, computer networking, and security. A deep understanding of executing highly scalable, distributed applications in cloud environments. Demonstrated ability to work effectively in cross-functional groups and generate results. Excellent interpersonal, oral, and written communication skills. Must convey responsiveness and competence when dealing with internal customers, staff, peers, senior management, and vendors. Work experience that demonstrates a strong sense of ownership, urgency, and drive. Background and drug screen. Preferred Qualifications Experience with large-scale enterprises scaling out operations in Amazon Web Services is highly favorable. Experience with migrating application & data services from on-prem to Cloud. Strong understanding of SRE, Quality Engineering and Release Engineering best practices. Experience with 24/7 Production Support environment. Physical Requirements Working conditions consist of a normal office environment. Work is primarily sedentary and requires extensive use of a computer and involves sitting for periods of approximately four hours. Work will require standing, walking, kneeling, bending and reaching to identify asset information on fixed hardware. Must be able to lift up to 10 pounds occasionally and/or negligible amount of force frequently. Requires visual acuity and dexterity to view, prepare, and manipulate documents and office equipment including personal computers. Requires the ability to communicate with internal and/or external customers. Employee must be able to perform essential functions and physical requirements of position with or without reasonable accommodation. The base pay scale for this position in: Phoenix, AZ/ Chicago, IL in USD per year is: $289,000 - $372,000. New York, NY/ San Francisco, CA in USD per year is: $318,000 - $409,000. Additionally, candidates are eligible for a discretionary incentive plan and benefits. This pay scale is subject to change and is not necessarily reflective of actual compensation that may be earned, nor a promise of any specific pay for any specific candidate, which is always dependent on legitimate factors considered at the time of job offer. Early Warning Services takes into consideration a variety of factors when determining a competitive salary offer, including, but not limited to, the job scope, market rates and geographic location of a position, candidate's education, experience, training, and specialized skills or certification(s) in relation to the job requirements and compared with internal equity (peers). The business actively supports and reviews wage equity to ensure that pay decisions are not based on gender, race, national origin, or any other protected classes. Some of the Ways We Prioritize Your Health and Happiness Healthcare Coverage- Competitive medical (PPO/HDHP), dental, and vision plans as well as company contributions to your Health Savings Account (HSA) or pre-tax savings through flexible spending accounts (FSA) for commuting, health & dependent care expenses. 401(k) Retirement Plan- Featuring a 100% Company Safe Harbor Match on your first 6% deferral immediately upon eligibility. Paid Time Off- Flexible Time Off for Exempt (salaried) employees, as well as generous PTO for Non-Exempt (hourly) employees, plus 11 paid company holidays and a paid volunteer day. 12 weeks of Paid Parental Leave Maven Family Planning - provides support through your Parenting journey including egg freezing, fertility, adoption, surrogacy, pregnancy, postpartum, early pediatrics, and returning to work. And SO much more! We continue to enhance our program, so be sure to check our Benefits page here for the latest. Our team can share more during the interview process! Early Warning Services, LLC ("Early Warning") considers for employment, hires, retains and promotes qualified candidates on the basis of ability, potential, and valid qualifications without regard to race, religious creed, religion, color, sex, sexual orientation, genetic information, gender, gender identity, gender expression, age, national origin, ancestry, citizenship, protected veteran or disability status or any factor prohibited by law, and as such affirms in policy and practice to support and promote equal employment opportunity and affirmative action, in accordance with all applicable federal, state, and municipal laws. The company also prohibits discrimination on other bases such as medical condition, marital status or any other factor that is irrelevant to the performance of our employees. Early Warning Services LLC is a proud participant in E-Verify, a federal program to help ensure a legal and authorized workforce. As part of our hiring process, we electronically verify the employment eligibility of all new hires through E-Verify. For more information on your rights and responsibilities under E-Verify please visit Home | E-Verify.
Posted 1 week ago
Wayne Farms, Inc.Laurel Regional Office, MS
EARLY CAREERS- Launch your career. Grow your impact. Lead the future. 2026 Summer Internship Program Dates: May 18 - July 31, 2026 Join our immersive 11-week internship designed to provide hands-on experience, professional development, and exposure to industry leaders. What You Can Expect as an Intern: Industry Exposure with real-world project experience Skill Development & Building Workshops Career Development & Support Insight Into Our Company Culture Leadership Engagement Candidate Requirements: Currently enrolled in an associate, bachelor's or graduate degree program majoring in Poultry Science, Animal Science, Food Science, Chemistry, Biology/Biochemistry, Microbiology, or related major. Must be at least 18 years of age. Resume Required What Makes a Successful Intern: Strong verbal and written communication skills, with the ability to present findings clearly to peers, managers, and senior leaders. Analytical mindset with the ability to collect and interpret data, form hypotheses, and recommend long-term solutions. Flexibility to work non-standard hours as needed to collect data; occasional overnight travel may be required. Self-motivated and organized, with the ability to manage multiple tasks and maintain attention to detail. Willingness to build relationships with mentors, peers, and professionals to expand industry knowledge and interpersonal skills. Perform additional duties as assigned. Safety Requirements: Safety is a top priority. Interns are expected to follow all departmental and company safety protocols and wear appropriate PPE when 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 2 weeks ago
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
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
PwCSan Francisco, 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
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 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
Eli Lilly and CompanyConcord, CA
$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. Job Summary The Continuous Improvement Leader- QA Batch Disposition Team assures patients worldwide of safe and efficacious drug and device products, through effective quality oversight of site activities. The Continuous Improvement Leader- QA Batch Disposition is responsible for driving operational excellence through Lean, Six Sigma, and other continuous improvement methodologies. This role partners with cross-functional teams to identify inefficiencies, implement solutions, and foster a culture of continuous improvement that delivers measurable results in quality and productivity, while also performing the role of an Authorized Quality Representative as required. Key Responsibilities Develop and execute a site-wide continuous improvement strategy for batch disposition aligned with business objectives. Facilitate Kaizen events, Value Stream Mapping sessions, and other workshops to identify and eliminate waste in the batch disposition process. Lead structured problem-solving initiatives using DMAIC, PDCA, and root-cause analysis tools and implement sustainable solutions developed locally and globally. Analyze operational data (OEE, cycle time, throughput) to identify improvement opportunities in the batch disposition process. Support training and coaching of batch disposition team members as needed. Track and report progress of improvement projects, including KPI performance. Promote a culture of operational excellence through visual management and standard work for the batch disposition team. Mentor internal team and develop future leaders in continuous improvement. Develop and manage weekly, monthly, quarterly targets for batch disposition. Perform final release of device assembly and packaging products as required. Ability to work overtime as required, including nights and weekends as required. Other duties as assigned/required. Required Qualifications Bachelor's degree in STEM. Experience in batch disposition and leading continuous improvement initiatives in manufacturing, supply chain, or similar environments. Strong analytical skills with proficiency in data analysis and process metrics. Excellent communication, leadership, and change management skills. Experience with ERP/MES systems and data visualization tools. Ability to influence and engage stakeholders at all organizational levels. 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 2 weeks ago
Riot GamesLos Angeles, CA
As the Director of Quality Assurance for Teamfight Tactics, you will shape and drive the quality vision for one of Riot's fastest-growing global products. You'll be accountable for defining and executing QA strategies that ensure every TFT player experiences a consistently high-quality, globally resonant game. This role is both operational and strategic-you'll lead a team of QA managers and embedded quality professionals across multiple initiatives and regions while also influencing the broader quality culture within TFT and across Riot. You will partner closely with Product, Engineering, Design, Art, and Operations leaders to integrate quality as a core pillar of TFT's ongoing development and delivery. This is a rare opportunity to impact one of the most innovative strategy games in the industry while mentoring and scaling a high-performing QA organization. This role reports to the Senior Director of Operations, TFT. Responsibilities: Strategic & Organizational Leadership Define and execute a scalable, long-term QA vision and roadmap that aligns with TFT's operational and product strategies. Act as the QA leader for TFT, directly managing QA Managers and overseeing QA professionals globally. Own QA org structure, hiring, and resourcing plans, aligned with budget and team growth needs. Influence TFT product leaders and cross-functional stakeholders to embed quality considerations throughout the product lifecycle. Develop a culture of ownership, accountability, and innovation within the QA discipline. Craft & Technical Excellence Drive the adoption of modern test strategies, automation frameworks, and tooling that support multi-platform development (PC, Mobile). Partner with Riot-wide QA leadership to evolve global quality standards and practices. Establish and track KPIs and quality metrics that assess product health and guide continuous improvement. Contribute to the global QA craft strategy and represent TFT in broader Riot quality forums. People & Talent Development Be a coach and mentor to QA leaders, investing in their growth and career progression. Foster an inclusive and engaging team culture where Rioters do their best work. Identify and address capability gaps across the QA team, proactively building future-ready talent pipelines. Required Qualifications: 10+ years of QA experience, including 4+ years managing QA Managers or multi-team organizations. Proven experience owning QA strategy and delivery for complex, multi-platform live service games. Deep knowledge of test strategy development, quality measurement, and automation practices. Experience managing distributed and remote QA teams across regions. Demonstrated success in managing budgets, headcount, and resource prioritization across large teams. Effective executive communication and collaboration skills, with a track record of influencing senior leadership. Desired Qualifications: Experience with hybrid internal/external QA vendor models. Familiarity with TFT, strategy games, or systems-heavy live-service games. Development and QA experience across platforms: PC, Mobile, Console. ISTQB Foundation For this role, you'll find success through craft expertise, a collaborative spirit, and decision-making that prioritizes the delight of players. We will be looking at your past studies, experience, and your personal relationship with games. If you embody player empathy and care about players' experiences, this could be your role! Our Perks: Riot focuses on work/life balance, shown by our open paid time off policy and other perks such as flexible work schedules. We offer medical, dental, and life insurance, parental leave for you, your spouse/domestic partner, and children, and a 401k with company match. Check out our benefits pages for more information. At Riot Games, we put players first. That mission drives every decision in our quest to create games and experiences that make it better to be a player. Whether you're working directly on a new player-facing experience or you're supporting the company as a whole, everyone at Riot is part of our mission. And just like in our games, we're better when we work together. Our goal is to create collaborative teams where you are empowered to bring your unique perspective everyday. If that sounds like the kind of place you want to work, we're looking forward to your application. It's our policy to provide equal employment opportunity for all applicants and members of Riot Games, Inc. Riot Games makes reasonable accommodations for handicapped and disabled Rioters and does not unlawfully discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, handicap, veteran status, marital status, criminal history, or any other category protected by applicable federal and state law. We consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with applicable federal, state and local law, including the California Fair Chance Act, the City of Los Angeles Fair Chance Initiative for Hiring Ordinance, the Los Angeles County Fair Chance Ordinance for Employers, the San Francisco Fair Chance Ordinance, and the Washington Fair Chance Act. Per the Los Angeles County Fair Chance Ordinance, the following core duties may create a basis for disqualifying candidates with relevant criminal histories: Safeguarding confidential and sensitive Company data Communication with others, including Rioters and third parties such as vendors, and/or players, including minors Accessing Company assets, secure digital systems, and networks Ensuring a safe interactive environment for players and other Rioters These duties are directly related to essential operations, safety, trust, and compliance obligations within our organization. Please note that job duties may evolve based on business needs and additional responsibilities may be assigned as necessary to maintain operational efficiency and security.
Posted 4 weeks ago
Sony Playstation NetworkLos Angeles, CA
$34 - $51 / hour
Why PlayStation? PlayStation isn't just the Best Place to Play - it's also the Best Place to Work. Today, we're recognized as a global leader in entertainment producing The PlayStation family of products and services including PlayStation5, PlayStation4, PlayStationVR, PlayStationPlus, acclaimed PlayStation software titles from PlayStation Studios, and more. PlayStation also strives to create an inclusive environment that empowers employees and embraces diversity. We welcome and encourage everyone who has a passion and curiosity for innovation, technology, and play to explore our open positions and join our growing global team. The PlayStation brand falls under Sony Interactive Entertainment, a wholly-owned subsidiary of Sony Group Corporation. Join the award-winning team that created God of War Sony Santa Monica Studio is looking for QA Leads to support our internal projects on the PS5 platform. The QA Lead is responsible for the facilitation of direct development team support, operational title gameplay test planning, execution, advancement, organization, coverage, execution and communication for their assigned projects. The general purpose of this job is to provide a technically proficient, dedicated resource that is completely focused on the direct operational oversight of all internal and external title QA operational testing services for their assigned project(s), to provide effective test support, efficient test execution and accurate test results to development and production teams. This role also includes the facilitation of internal production for QA, as well as leadership of our external partnerships with our SIE and 3rd party vendor support services related to testing. An in-depth comprehension of the Santa Monica Studio development pipeline, tools, development team structure, workflows and production mindset are foundational to this role. Attention to detail is a critical requirement of the role, as is a highly communicative, amicable, adaptable, growth-minded and mature demeanor in supporting the development team. We value those that have a mindset of OWNERSHIP, diligence in their CRAFTSMANSHIP, a commitment to PARTNERSHIP and humility in their LEADERSHIP. In turn, we will work alongside you to craft an environment that empowers and equips you with the freedom to create better, the autonomy to think better, the opportunity to grow better and the feedback to choose to "Be Better". Responsibilities The effective planning, administration, execution and communication of QA Master Test Plans and the effective incorporation of them into the software development process The administration and communication of all QA related project data and associated risks for all assigned projects The operational training, development, and delegation to assigned Assistant Leads, Sr Test Analysts and Testers The managing of developer support requests and efficiently balancing them with our day-to-day test services The balancing of tactical day to day responsibilities with the need to advance, refine and implement new QA processes and systems to further drive test service effectiveness, efficiency, accuracy and overall value The consistent modeling of all core SMS values in support of the SMS Mission and Vision The consistent modeling of all core SMS QA expectations and job profile competencies The learning and in depth understanding of the development team structure, discipline workflows and discipline roles The learning and in depth understanding of the SMS software development cycle and core development tools The facilitation of communication and QA support directly with the production and development teams Ownership of the development, tasking and execution of all operational testing for assigned projects Ownership over managing of project databases for assigned titles Partnering with assigned Assistant Leads regarding establishing an efficient relationship with clear areas of responsibility between them that is aligned with the SMS QA Team Expectations Partnering with the production and development team in supporting and collaborating work across disciplines to help effectively drive the project to completion Partnering with QA Sr Managing Producer, in the operational performance management of assigned Assistant Leads, Sr Test Analysts and Testers Requirements Responsible, strong work ethic, self-motivated and pro-active Minimum of 3 years in Senior Test Analyst or equivalent position in development integrated role Successfully shipped at least 2 AAA titles on current generation console platforms and/or PC Successfully completed certification and application of ISQTB Foundation and Intermediate Level CTAL Demonstrated knowledge of Software Development Lifecycle Demonstrated knowledge of build authoring pipeline, processes, and systems Demonstrated ability to thrive in a high pressure, high workload environment balancing multiple responsibilities Demonstrated knowledge of test case design well as advanced QA/QC methods Demonstrated knowledge of QA and game development systems, tools, and database utilization Demonstrated knowledge and experience with advanced testing and automation methods Demonstrated knowledge and experience with Maya, Jenkins, Perforce and other common software development tools Demonstrated knowledge and experience authoring wiki in confluence content for technical and non-technical audience Demonstrated knowledge and experience with 3rd party test and support services remote management Demonstrated knowledge of all current PlayStation development and retail hardware Demonstrated knowledge of all current PlayStation platform SDK's and debug tools Demonstrated knowledge of TestFlo, TestRail, or equivalent test management software Demonstrated knowledge of Jenkins or equivalent automation testing tools and languages Demonstrated experience leading, coaching and mentoring staff, both technically and behaviorally Demonstrated knowledge of and maturity in emotional intelligence Exceptional organizational skills Exceptional written and verbal communication skills Excellent critical analysis and problem-solving skills Excellent gameplay skills and multi-genre experience Passion for video games Preferred Experience BS Cognitive Science, Computer Science, Communications, BA in Project Management, Business Intelligence, or QA related field Successfully completed, certification and application of SQE Mastering Test Design Foundation Level Demonstrated knowledge of PlayStation Studios QA Operations processes, systems and workflows Successful completion, certification and application of ISQTB Advanced Level CTAL Successful completion, certification and application of PMI CAPM Demonstrated knowledge of SMS game development applicable programming and scripting languages, such as Dart, Java, JavaScript, C, C#, C++, and Python Expertise in and familiarity with Agile techniques, including Kanban and SCRUM Expertise in QA/QC analytics Expertise in remote team management #LI-SMS #LI-MC1 Avoid Recruitment Scams/Phishing Attempts: Please be aware that any official outreach in response to your application will always be done from a @sony.com email address. Always make sure to double check the spelling on Sony is correct and the characters have not been replaced with any numbers/symbols before replying. Anyone using an email that is not @sony.com is not affiliated with us and should be reported either via the platform they are contacting you on or directly to your email service as a phishing attempt/scam. Please refer to our Candidate Privacy Notice for more information about how we process your personal information, and your data protection rights. At SIE, working with our partners, we consider several factors when setting each role's base pay range, including the competitive benchmarking data for the market and geographic location. Please note that the individual base pay range may vary based on job-related factors which may include knowledge, skills, experience, and location. In addition, this role is eligible for benefit offerings that include medical, dental, and vision. Click here to learn more. The estimated base pay range for this role is listed below, this is an hourly rate. $34.24-$50.99 USD Equal Opportunity Statement: Sony is an Equal Opportunity Employer. All persons will receive consideration for employment without regard to gender (including gender identity, gender expression and gender reassignment), race (including colour, nationality, ethnic or national origin), religion or belief, marital or civil partnership status, disability, age, sexual orientation, pregnancy, maternity or parental status, trade union membership or membership in any other legally protected category. We strive to create an inclusive environment, empower employees and embrace diversity. We encourage everyone to respond. PlayStation is a Fair Chance employer and qualified applicants with arrest and conviction records will be considered for employment.
Posted 30+ days ago
PwCLouisville, KY
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
PwCStamford, CT
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
Lonza, Inc.Tampa, FL
The QA Deviation Specialist is responsible for identifying, documenting, investigating, and resolving deviations, unplanned events, complaint investigations in accordance with company SOPs, policies, cGMPs, protocols, or regulatory requirements. This is a cross-functional position that interacts with all departments at Lonza Tampa. The role is responsible for authoring, reviewing, and/or providing the final Quality approval for investigations into manufacturing, packaging and/or laboratory events/deviations. Key Accountabilities: Facilitate and lead assigned investigations involving multiple investigation areas. Work with various departments, including manufacturing, packaging, quality control, maintenance, engineering, and supply chain, to conduct investigations, determine root cause and implement improvements. Perform investigations using structured root cause analysis tools (fishbone, 5 Why's, etc.) and partner with team members to determine "true" root cause. Analyze deviation trends and provide insights for continuous improvement initiatives. Ensure that investigations and reports are completed and closed within specified timelines. Assess deviation potential impact to product quality for root cause, corrective or preventive actions and impact to product safety, identity, strength, quality or purity. Determine the appropriate actions needed to prevent the recurrence of the event and define the criteria for evaluating the CAPA's effectiveness. Review, update and approve Standard Operating Procedures (SOPs) and other company documents. Facilitate and participate in initiatives to address compliance gaps identified during investigations with minimal assistance. The role interacts with all levels of the organization and is expected to use professional judgment in appropriate issue escalation to management. Prepare and present deviation reports to management and regulatory authorities as the need arises. Ensure that documentation is completed following Good Documentation Practices (GDP). Support regulatory inspections, internal audits, and customer audits as required. Perform additional job-related assignments as requested by management. Key Requirements: Bachelor's degree in science, preferably chemistry. 3 years of experience in quality assurance, deviation management, or a related role in [industry, e.g., pharmaceuticals, manufacturing, etc.]. Knowledge of regulatory requirements (e.g., FDA, EMA, ISO) and industry standards. Strong analytical and problem-solving skills. Excellent communication and interpersonal skills. Every day, Lonza's products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically. People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference. Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.
Posted 30+ days ago
RBC BearingsPlymouth, IN
Inspect product to ensure conformance with work orders and specifications. Conduct dimensional checks on sample audits from inspection. Sets up gauges to determine diameter and length. Change master pin in gauge in accordance with parts dimensions. Conduct roundness testing utilizing electronic gauge. Measures end squareness using manual gauge. Obtain hardness measures using Rockwell hardness tester. Measures surface finish of roller using parameter electronic gauge. Completes non-conformance material forms indicating dimension deviations. May use electronic gauge as well as trend setter gauge to provide digital readout of dimensional measurement and or any hand gauging equipment and/or use of comparators. Use Rondcom 41C for roundness inspection. Places inspected parts in barrel or jugs; places jugs in boxes. Uses stapler to make boxes. Uses scales to weigh product. Maintains supplies such as jugs, skids, lids, etc. Uses forklift, pallet jack and/or barrel carts. Maintains all paperwork involved with job requirements. Keep work area clean and organized.
Posted 30+ days ago
Mistral AIParis, TX
About Mistral At Mistral AI, we believe in the power of AI to simplify tasks, save time, and enhance learning and creativity. Our technology is designed to integrate seamlessly into daily working life. We democratize AI through high-performance, optimized, open-source and cutting-edge models, products and solutions. Our comprehensive AI platform is designed to meet enterprise needs, whether on-premises or in cloud environments. Our offerings include le Chat, the AI assistant for life and work. We are a dynamic, collaborative team passionate about AI and its potential to transform society. Our diverse workforce thrives in competitive environments and is committed to driving innovation. Our teams are distributed between France, USA, UK, Germany and Singapore. We are creative, low-ego and team-spirited. Join us to be part of a pioneering company shaping the future of AI. Together, we can make a meaningful impact. See more about our culture on https://mistral.ai/careers . Role summary We are seeking a skilled and proactive QA Engineer to join our team and ensure the reliability, accuracy, and robustness of our AI-powered products. In this role, you will design and execute test strategies for our applications, APIs and machine learning models. Your work will involve automated testing, edge-case analysis, and collaboration with cross-functional teams to deliver seamless, high-quality user experiences. If you thrive in a dynamic environment and are passionate about quality in AI systems, this is a perfect opportunity to make a tangible impact. What you will do Test Automation: Develop automated test suites to validate app features, APIs, and model integrations, ensuring end-to-end reliability and user experience. Edge Case Analysis: Collaborate with PMs and other stakeholders to identify and rigorously test edge cases, improving the robustness of both platform features and models. Quality Platform Development: Contribute to building tools and frameworks that enable more efficient and scalable quality testing processes across the organization. Release Readiness Validation: Implement pre-release quality gates to validate models, APIs, and platform updates, providing a green light for production releases. Systematic QA Campaigns: Design and lead comprehensive quality assurance campaigns, including functional, stress, and performance testing, to proactively identify potential issues. About you You have proven ability to create and execute comprehensive test strategies, covering functional, regression, and exploratory testing for AI products. You are proficient in QA tools like Playwright, Postman, or similar platforms for API and functional testing. You're skilled in identifying, documenting, and collaborating with developers to resolve issues efficiently. You are autonomous and a self-starter. You are a proactive problem-solver with a continuous improvement mindset. You are proficient in Python or Typescript. Now it would be ideal if you have : Experience testing Machine Learning models. Understanding of the Machine Learning lifecycle. Experience in various types of testing : performance, load, accessibility or others Strong debugging skills. Hiring Process Recruiter Screening (45min) Hiring Manager Interview (30min) Take-home test Live-Coding (Scripting) (60min) Culture-fit discussion (30min) Location & Remote The position is based in our Paris HQ offices and we encourage going to the office as much as we can (at least 3 days per week) to create bonds and smooth communication. Our remote policy aims to provide flexibility, improve work-life balance and increase productivity. Each manager can decide the amount of days worked remotely based on autonomy and a specific context (e.g. more flexibility can occur during summer). In any case, employees are expected to maintain regular communication with their teams and be available during core working hours. What we offer Competitive salary and equity package ️ Health insurance Transportation allowance Sport allowance Meal vouchers Private pension plan Generous parental leave policy We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
Posted 1 week ago
American Regent LaboratoriesNew Albany, OH
Nature and Scope This position is a member of the Quality Assurance team. This position is responsible for ensuring the overall Quality in their assigned areas through the execution of site policies and procedures, programs and work instructions. Ensures all processes and products meet specifications and that products are produced in accordance with GMP requirements. This position is responsible for participating in material receipt, then coordinating sampling and inspection for components, in a sterile manufacturing facility. This position is responsible for ensuring the overall Quality of materials as assigned by Quality Management in coordination with other stakeholders such as Materials Management and Operations, etc. 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. Responsible for execution of procedural documentation as they pertain to various aspects of the receiving and sampling processes. Performs sampling of components. Conduct verifications and checks through accurate material inspections. Identify out of specification materials ensuring segregation and escalation, and perform any activities required within the Trackwise Events system Management of BPCS for verification and disposition of materials Maintain retain samples for all primary and secondary components and labeling Performance of DAF (Destruction Approval) process for rejected materials Use of Trackwise and Veeva for change controls, as needed Ensure errors and omissions are resolved according to Standard Operating Procedure (SOP) requirements Ensure all work is performed and documented in accordance with existing Company policies and procedures, as well as cGMP, health and safety requirements. Ensure all components and raw materials are appropriately prepared for the applicable status disposition, including all relevant documentation. Support generation of logbooks and sheets/labels as required. Basic knowledge of cGMPs and supporting regulatory documents Perform room, area and equipment clearances that may be necessary for this job function. Able to perform tasks with minimal error rate. Assist other Quality Assurance Operations Associates, as needed. 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 Diploma or GED equivalent required. Associates or Bachelor's Degree preferred. At least two (2) years of related experience (QA, Compliance, Auditing, Laboratory or Inspection, within a GMP environment) preferred. Must be able to do work independently. Experience in QA working in a cGMP manufacturing environment (preferred) Working knowledge and understanding of quality assurance principles and familiarity with QA programs Strong analytical skills, attention to detail and adherence to procedures. Intermediate skills in Microsoft Word and Excel are required. Excellent organizational, interpersonal and communication skills (written and oral) required. Ability to take feedback constructively and function in a team-oriented work environment. 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, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees. Specific vision requirements include 20/20 near vision (can be corrected with eyeglasses or contacts) and color vision. Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly. Employee must be able to occasionally lift and/or move up to 25 pounds. 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
Everly HealthAustin, TX
Everlywell is a digital health company pioneering the next generation of biomarker intelligence-combining AI-powered technology with human insight to deliver personalized, actionable health answers. We transform complex biomarker data into life-changing insights-seamlessly integrating advanced diagnostics, virtual care, and patient engagement to reshape how and where health happens. Over the past decade, Everlywell has delivered close to 1 billion personalized health insights, transforming care for 60 million people and powering hundreds of enterprise partners. In 2024 alone, an estimated 1 in 86 U.S. households received an Everlywell test, solidifying our spot as the #1 at-home testing brand in the country. And we're just getting started. Fueled by AI and built for scale, we're breaking down barriers, closing care gaps, and unlocking a more connected healthcare experience that is smarter, faster, and more personalized. We're looking for a Senior QA Engineer who thrives in an AI-first engineering culture - one where artificial intelligence is not just a tool, but a force multiplier that enhances speed, creativity, and coverage in quality assurance. In this role, you'll own the development and automation of test cases and test infrastructure, and you'll leverage AI to accelerate and augment every aspect of QA: from generating tests based on product specs to writing and maintaining automated test suites, and surfacing insights from bugs and data anomalies. You'll collaborate closely with engineering, product, and design to ensure a culture of quality is embedded from day one, and your AI-enhanced workflows will set the bar for what a modern QA practice can achieve. What You'll Do: Use AI tools like Cursor to rapidly generate test cases from requirements, user stories, and code diffs. Build and maintain automated end-to-end test suites using frameworks like Cypress, Playwright, or Selenium, with AI assistance to speed up development and catch edge cases. Integrate AI-driven static analysis, code coverage tools, and anomaly detection into CI/CD pipelines. Define and manage test strategies for new product features with a focus on AI-augmented speed and accuracy. Use LLMs and agents to simulate user behavior for broader scenario coverage. Continuously evaluate and implement AI-powered QA platforms to improve regression, smoke, and exploratory testing. Collaborate with engineers on shift-left testing practices, pairing during development to catch issues early. Monitor application performance, errors, and logs using tools like Sentry, DataDog, or equivalent - augmented by AI-powered alerting and triage. Contribute to defining AI-first QA best practices, playbooks, and tooling standards across the team. Who You Are: 4-6+ years of experience in QA engineering, software testing, or quality automation. Strong experience with automated testing frameworks (e.g., Cypress, Playwright, Selenium). Demonstrated usage of AI tools to accelerate or enhance QA processes - such as Cursor, Copilot, Testim, CodiumAI, Diffblue, or custom LLM-based tools. Familiarity with writing, maintaining, and optimizing automated tests for modern web applications (React/Next.js preferred). Deep understanding of CI/CD, test environments, and software deployment practices. Strong analytical and debugging skills - able to quickly identify root causes and work cross-functionally to resolve issues. Proactive communicator who thrives in a collaborative, high-velocity environment. Nice to Have: Experience with AI agents for QA (e.g., auto-test authors, regression explorers, or defect triagers). Familiarity with backend testing, including API-level test automation (Postman, REST Assured, etc). Exposure to healthcare or regulated industries. Knowledge of performance testing tools (e.g., k6, JMeter) or visual regression testing suites. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
Posted 30+ days ago
Lonza, Inc.Portsmouth, NH
Today, Lonza is a global leader in life sciences operating across five continents. While we work to deliver new therapies, we also support our employees in building rewarding careers. Join us and help shape the future of life sciences. The actual location of this job is on site in Portsmouth, NH. As a QA Specialist II - Raw Materials Compliance, you will support the operational compliance of the raw material lifecycle, including receipt, storage, handling, testing, dispensing, and disposition. You will also assist with final product storage and shipping logistics. This role is a developing Subject Matter Expert (SME) in cGMP documentation review and approval for raw materials, working closely with Supply Chain, Quality Control, and Manufacturing teams. What you will get: An agile career and dynamic working culture. An inclusive and ethical workplace. Compensation programs that recognize high performance. Medical, dental, and vision insurance. Our full list of global benefits can be found here: https://www.lonza.com/careers/benefits . What you will do: Perform SAP transactions and other quality functions to support raw material lifecycle. Provide on-the-floor support for raw material requests, including inspection and labeling. Review material documents for disposition to ensure timely release. Review and approve SOPs, work instructions, and validation documents in DMS. Review and approve records in QMS (e.g., investigations, change controls, CAPAs). Collaborate with Supply Chain, Quality Control, and Manufacturing for raw material support. Participate in projects and routine meetings with minimal guidance. What we are looking for: Associate's degree in life sciences required; equivalent experience considered. 0-4 years of experience in Quality Assurance or GMP environments. Knowledge of GMP regulations and raw material compliance preferred. Familiarity with SAP, TrackWise, and Microsoft Office Suite preferred. Strong communication skills and ability to manage changing priorities. Attention to detail and ability to work independently and in teams. Business-fluent English required. About Lonza At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone's ideas, big or small, have the potential to improve millions of lives, and that's the kind of work we want you to be part of. Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. If you're ready to help turn our customers' breakthrough ideas into viable therapies, we look forward to welcoming you on board. Ready to shape the future of life sciences? Apply now.
Posted 30+ days ago
Lebermuth, Inc.South Bend, IN
Apply Job Type Full-time Description Lebermuth Company is currently looking for a Quality Assurance Compliance Specialist to join our team. Lebermuth Company, a family-owned leader in the fragrance and flavor industry, has been blending tradition with innovation for over a century. Specializing in essential oils, fragrances, and flavors, Lebermuth is dedicated to quality and integrity. Our commitment to excellence is evident in our personal touch, sustainable practices, and customer-centric approach. Summary: The QA Compliance Specialist is responsible for administering and coordinating quality programs to ensure compliance with FDA, FSMA, SQF, HACCP, and other applicable state and federal regulations. This role partners with procurement and cross-functional teams to maintain a robust supplier quality program and supports continuous improvement initiatives across the organization. Essential Duties & Responsibilities: Serves as the primary SQF Practitioner and PCQI; oversees Verification & Validation, Document Control, Foreign Material Management, and Environmental Monitoring programs. Manages Pest Control Programs and 3rd party contractors supporting Quality and Food Safety initiatives. Facilitates 3rd-party laboratory testing for raw materials and finished products to meet EPA/FDA and certification requirements (e.g., Organic). Responsible for managing the Supplier Approval Program by overseeing supplier level approvals, partnering with regulatory team to maintain accurate and current supplier data, and administering the Supplier Approval Database to ensure compliance and program integrity Administers the Alchemy training program; collaborates with QEHS and other departments on annual training needs. Leads internal auditing program; communicates schedules and results to leadership. Facilitates corrective and preventive action (CAPA) processes to drive continuous improvement. Supports Regulatory department during governmental, third-party, and customer audits. Promote food safety culture by maintaining a clean and organized workspace and adhering to all quality and safety standards within the department to ensure the safe production and shipment of quality food products Performs other duties as assigned to support compliance and quality objectives. Requirements Qualifications: Education: Bachelor's degree in food science, Quality Assurance, Business, or related fields of study, or an equivalent combination of education and experience. Experience: 2+ years of related experience and/or training; Knowledge base representative of the position includes experience with SQF, cGMP and HACCP programs. Certifications: SQF Practitioner, PCQI, and HACCP. Functional Skills: Strong planning, organizational, and executing skills are required; technical aptitude, with lean thinking/process improvement skillsets, are needed to problem-solve and enhance the operations; excellent forward-thinking, prioritization, analytical, and detail-oriented skills are required to manage multiple data points. Analytical problem solving, effective communication and partnership development Technology Aptitude/Skills: Basic knowledge of computer and keyboard functions. Strong working knowledge and experience with MRP/ERP systems and familiarity with regulatory-related programs. Proficiency with Microsoft Office products, particularly Excel. Language Skills: Strong verbal and written communication skills. Demonstrates advanced group presentation skills, presents information effectively and responds to questions from owners and management teams Ability to read, analyze and interpret professional journals, technical procedures, governmental regulations, and chemical hazard information and safety procedures. Ability to write correspondence that is professional in both content and tone. Ability to effectively present information and respond to questions. Leadership/Behavior Skills: Self-motivated to stay focused on quality and output goals; strong work ethic and values, sound judgement, dependable, focused on the customer and processes; high level of accuracy and attention to detail with the flexibility to move to priorities throughout the operation areas, following all Safety requirements Culture Match Behaviors: Enjoys and thrives in a fast-paced, high-growth environment, with a huge drive to create an impact while also being an effective listener, respectful problem-solver and a collaborative continuous learning team member. Physical and Sensory Demands / Environmental Conditions / Equipment Used This role routinely uses standard office equipment such as computers, phones, electronic devices, photocopiers, filing systems/cabinets and fax machines. Ability to operate keyboard and view computer screen occasionally. Ability to write ideas/information in a logical flow occasionally. Cognitive and reasoning ability to read, review and interpret work orders or processes on a frequent basis. Ability to read and respond due to nature of the work on a frequent basis. Ability to talk and communicate with others via phone, in-person, and/or computer frequently. Ability to listen to others, solve problems, and respond frequently. Ability to stand, sit, walk, climb, bend, stoop, kneel, crouch, reach, squat, twist, push, pull, and carry items frequently. Ability to lift/move up to 15lbs sporadically. Ability to work in a manufacturing environment with fluctuating temperatures and noise levels. The employee is required to wear suitable Personal Protective Equipment such as safety glasses, hair/beard nets and steel toed shoes, as required. Work schedule is generally 1st shift, generally Monday through Friday, but at times requires on-call and non-traditional work hours, to meet business needs Salary Description Hourly Non Exempt
Posted 30+ days ago
PwCWashington, DC
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
VP, Engineering - SRE / QA
Early Warning Services, LLCChicago, IL
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Job Description
At Early Warning, we've powered and protected the U.S. financial system for over thirty years with cutting-edge solutions like Zelle, Paze℠, and so much more. As a trusted name in payments, we partner with thousands of institutions to increase access to financial services and protect transactions for hundreds of millions of consumers and small businesses.
Positions located in Scottsdale, San Francisco, Chicago, or New York follow a hybrid work model to allow for a more collaborative working environment.
Candidates responding to this posting must independently possess the eligibility to work in the United States, for any employer, at the date of hire. This position is ineligible for employment Visa sponsorship.
Overall Purpose
This position will lead the Zelle Engineering organization. Zelle's growth since launch in 2017 has been astronomical, with many enhancements along the way to keep the system stable and performant - as we look forward for the next decade at the growth and capabilities of the network there are opportunities to evolve key parts of the network's tech stack to accomplish everything from orders of magnitude, additional growth in use, in addition to improvements like easier Financial Institution integration opportunities.
We are starting a significant multi-year journey of maturing core components of Zelle into a Cloud-based environment and this leader will need to have extensive experience in this space.
This position will be leading these efforts in collaboration with internal stakeholders as well as potentially external (FI) partners to drive that next decade of vision for Zelle.
Essential Functions
- Able to understand and juggle multi-faceted roadmap requirements covering Product asks, re-platforming needs, maintenance and security work across the Zelle Engineering organization to deliver on success in many areas.
- Utilizes knowledge and lessons-learned from building enterprise-scale systems in the cloud to help drive best practices, architectures and technology decisions inside the Zelle organization.
- Collaborates closely with Engineering leaders, Architecture and potentially external collaboration partners (FIs) that may be engaged with us on key efforts over the years.
- Maintains a very high bar for execution and excellence in the Engineering team, fostering leadership and executive presence throughout; can 'coach up' team members and leaders for a highly engaged, high-performing team, and hire top talent into the team to support these large-scale efforts.
- Identifies opportunities to ship value to Production quickly and in incremental chunks to avoid "big bang" delivery; complex environments benefit from incremental delivery.
- Builds and delivers well-considered Zelle scaling solutions via strong relationships with key stakeholders in the Data, Architecture and Operations organizations.
- Ensures software development follows effective quality guidelines and best practices in line with the rest of the Engineering organization.
- Ensures accurate/reliable information is provided within company standards including all service level agreements, and audit regulations.
- Ensures solutions are built following our Engineering best practices (e.g., Quality, CI/CD, etc.)
- Keeps executive-level management informed of department progress and problems.
- Complies with all security policies and procedures, to ensure that the highest level of system and data confidentiality, integrity and availability is maintained.
- Support the company's commitment to risk management and protecting the integrity and confidentiality of systems and data. The above job description is a summary of job responsibilities and is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow instructions and perform tasks and other duties as assigned by their supervisor.
Minimum Qualifications
- Education or experience typically obtained through completion of a Bachelor's degree in Computer Information Systems, Information Technology, Information Systems, Computer Science or equivalent professional experience.
- Minimum 15 or more years of software engineering experience
- Minimum 10 years or more experience in leading efforts or processes in a Technology organization.
- Minimum 5 or more years of software engineering experience dealing with large scale systems in the cloud.
- Minimum 5 or more years of experience implementing application solutions/ services in Cloud using Containerization, CI/CD, Automated testing and in compliance security guidelines.
- Minimum 10 years or more of experience in managing an Engineering organization.
- Demonstrated ability to provide technical leadership through large-scale system designs, upgrades, and releases.
- Superior leadership and management skills together with strong business acumen.
- Demonstrated ability to mentor and energize people showcasing technical and leadership skills.
- Demonstrated experience with state- of- the- art technology, architecture and design concepts, open-source operating systems, database systems, computer networking, and security.
- A deep understanding of executing highly scalable, distributed applications in cloud environments.
- Demonstrated ability to work effectively in cross-functional groups and generate results.
- Excellent interpersonal, oral, and written communication skills. Must convey responsiveness and competence when dealing with internal customers, staff, peers, senior management, and vendors.
- Work experience that demonstrates a strong sense of ownership, urgency, and drive.
- Background and drug screen.
Preferred Qualifications
- Experience with large-scale enterprises scaling out operations in Amazon Web Services is highly favorable.
- Experience with migrating application & data services from on-prem to Cloud.
- Strong understanding of SRE, Quality Engineering and Release Engineering best practices.
- Experience with 24/7 Production Support environment.
Physical Requirements
Working conditions consist of a normal office environment. Work is primarily sedentary and requires extensive use of a computer and involves sitting for periods of approximately four hours. Work will require standing, walking, kneeling, bending and reaching to identify asset information on fixed hardware. Must be able to lift up to 10 pounds occasionally and/or negligible amount of force frequently. Requires visual acuity and dexterity to view, prepare, and manipulate documents and office equipment including personal computers. Requires the ability to communicate with internal and/or external customers.
Employee must be able to perform essential functions and physical requirements of position with or without reasonable accommodation.
The base pay scale for this position in:
Phoenix, AZ/ Chicago, IL in USD per year is: $289,000 - $372,000.
New York, NY/ San Francisco, CA in USD per year is: $318,000 - $409,000.
Additionally, candidates are eligible for a discretionary incentive plan and benefits.
This pay scale is subject to change and is not necessarily reflective of actual compensation that may be earned, nor a promise of any specific pay for any specific candidate, which is always dependent on legitimate factors considered at the time of job offer. Early Warning Services takes into consideration a variety of factors when determining a competitive salary offer, including, but not limited to, the job scope, market rates and geographic location of a position, candidate's education, experience, training, and specialized skills or certification(s) in relation to the job requirements and compared with internal equity (peers). The business actively supports and reviews wage equity to ensure that pay decisions are not based on gender, race, national origin, or any other protected classes.
Some of the Ways We Prioritize Your Health and Happiness
Healthcare Coverage- Competitive medical (PPO/HDHP), dental, and vision plans as well as company contributions to your Health Savings Account (HSA) or pre-tax savings through flexible spending accounts (FSA) for commuting, health & dependent care expenses.
401(k) Retirement Plan- Featuring a 100% Company Safe Harbor Match on your first 6% deferral immediately upon eligibility.
Paid Time Off- Flexible Time Off for Exempt (salaried) employees, as well as generous PTO for Non-Exempt (hourly) employees, plus 11 paid company holidays and a paid volunteer day.
12 weeks of Paid Parental Leave
Maven Family Planning - provides support through your Parenting journey including egg freezing, fertility, adoption, surrogacy, pregnancy, postpartum, early pediatrics, and returning to work.
And SO much more! We continue to enhance our program, so be sure to check our Benefits page here for the latest. Our team can share more during the interview process!
Early Warning Services, LLC ("Early Warning") considers for employment, hires, retains and promotes qualified candidates on the basis of ability, potential, and valid qualifications without regard to race, religious creed, religion, color, sex, sexual orientation, genetic information, gender, gender identity, gender expression, age, national origin, ancestry, citizenship, protected veteran or disability status or any factor prohibited by law, and as such affirms in policy and practice to support and promote equal employment opportunity and affirmative action, in accordance with all applicable federal, state, and municipal laws. The company also prohibits discrimination on other bases such as medical condition, marital status or any other factor that is irrelevant to the performance of our employees.
Early Warning Services LLC is a proud participant in E-Verify, a federal program to help ensure a legal and authorized workforce. As part of our hiring process, we electronically verify the employment eligibility of all new hires through E-Verify. For more information on your rights and responsibilities under E-Verify please visit Home | E-Verify.
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