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Lonza, Inc. logo
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 Portsmouth, NH. As a Supervisor, QA Operations, you will lead a team of QA On-the-Floor Specialists who provide real-time quality support for GMP-related activities. This role ensures compliance, drives continuous improvement, and acts as a key liaison between Quality and other departments. The shift schedule for this role is subject to change as manufacturing support needs are realized. You will start on a day shift and transition to a night shift as part of the role requirements. 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: Lead and develop a team of QA On-the-Floor Specialists. Oversee training, mentoring, and performance feedback. Review executed batch records in real time on the production floor. Support manufacturing and other departments with quality needs. Manage escalations and make time-sensitive decisions. Represent QA in cross-functional meetings and audits. Drive continuous improvement and alignment across QA functions. What we are looking for: High school diploma required; bachelor's degree in life sciences preferred. 5-10 years of experience in cGMP environments. Strong knowledge of GMP regulations and quality systems. Excellent communication and leadership skills. Ability to manage priorities and make critical decisions under pressure. Experience mentoring and developing team members. 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

Johnson & Johnson logo
Johnson & JohnsonHorsham, PA

$94,000 - $151,800 / year

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com Job Function: Quality Job Sub Function: Quality Assurance Job Category: Professional All Job Posting Locations: Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America Job Description: Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine We are searching for the best talent for Sr QA Specialist IMSC NC CAPA to be in Raritan, New Jersey and Horsham, Pennsylvania Support efficient and effective investigation training/certification. Support NC/CAPA system and process user training Facilitate the initiation of investigations and CAPAs and monitor progress and approvals. Collaborate with key stakeholders to support the end-to-end NC/CAPA process. Support NC/CAPA system and process user training, including investigation certification. Facilitate initiation of investigations and CAPAs and monitor progress to ensure timely completion. Execute quality reviewer/approver duties, review evidence, and approve closure of NC and CAPA records. Conduct investigation record quality reviews for documentation completeness, robust root-cause analysis, and compliance with procedures. Monitor CAPA effectiveness and confirm root cause is eliminated or reduced to an acceptable level. Use data analytics and trending to identify failure modes, measure CAPA effectiveness, and inform continuous improvement priorities. Compile and provide regular CAPA status updates, metric reports, and trending analyses. Collaborate with stakeholders, site owners, governance bodies, and senior management to resolve issues and align on corrective actions; escalate risks or compliance issues to the Senior Manager, Quality Systems CAPA as needed. Coordinate with IMSC sites and responsible functions to drive completion of assigned actions. Partner with site NC/CAPA business process owners and J&J Quality Systems Platform Governance to sustain processes and support platform enhancement requests. Ensure the IMSC NC/CAPA process remains inspection-ready and support audits/inspections. Provide coaching and actionable feedback to issue owners on CAPA best practices, system usage, and investigation execution. Participate in and/or support internal audits and regulatory inspections, as needed. Attend, participate and/or facilitate SC NC CAPA review meetings, as needed. Perform other duties as necessary. Qualifications and Requirements: Bachelor's Degree in Life Science or related discipline or equivalent is required. Knowledge and experience with regulations and regulatory compliance issues. Minimum of 6 years' experience in a regulated MedTech or Pharmaceutical Quality Systems Compliance field and/or equivalent experience/training in a related NC CAPA Investigation Quality System area. Demonstrated experience as an investigator of Non-Conformance/CAPA process. Excellent communication and writing skills demonstrated by the ability to develop clear and concise professional correspondence. Requires critical analytical and problem-solving skills, strategic thinker, and collaborator. Excellent organization, prioritization, and time management skills. Demonstrated competencies include adaptability, attention to detail, and ability to build and maintain relationships and partnerships across the organization. Ability to build and maintain cross-functional interactions and coordination. Ability to build consensus, influence, and negotiate. Knowledge of Quality Management, Project Management and/or Process Excellence concepts and practices. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers . Internal employees contact AskGS to be directed to your accommodation resource. Required Skills: Preferred Skills: Business Alignment, Business Savvy, Coaching, Communication, Compliance Management, Continuous Improvement, Fact-Based Decision Making, Human-Centered Design, ISO 9001, Issue Escalation, Problem Solving, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Standard Operating Procedure (SOP) The anticipated base pay range for this position is : 94,000.00 - 151,800.00 Additional Description for Pay Transparency: The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis. • Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. • Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). • Employees are eligible for the following time off benefits: o Vacation - up to 120 hours per calendar year o Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year o Holiday pay, including Floating Holidays - up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year • Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits

Posted 5 days ago

LabCorp logo
LabCorpMadison, WI
Join our Labcorp Quality department as a Quality Auditor - Trainer in Madison, WI. Do you have 2 years' experience in a regulated environment training others? Are you looking to move your career into the quality within a Research facility? Must have LCMS background, either educational background in LCMS or active experience. This is a full-time benefitted, day position in Madison, Wisconsin! Join an exceptional organization and an exceptional Quality department. Essential Job Duties: Conduct work as defined Support 'business partner' /liaison meetings representing QA function with operations (local) Report on relevant quality metrics (for single topics/departments) and highlight trends Adhere to required timeline on assigned activities Peer Review QA SOP's Ensure Regulatory Compliance and Quality Assurance (RC&QA) responsibilities, as indicated in applicable controlled documents, are followed Minimum Required: 2 years in regulatory environment (experience in GXP roles) BioA and/or LCMS Knowledge of and ability to interpret and apply (applicable) regulations in order to monitor compliance Ability to interpret data and identify quality critical problems Able to convey regulatory expectations Education/Qualifications/Certifications and Licenses A minimum of a Bachelor's Degree in Life Sciences preferred (or equivalent Life Science experience) Experience may be substituted for education. Understanding of chromatography (i.e. HPLC) Experience with mass spectrometry/hybrid tandem mass spectrometry instrumentation Experience with plate reading technologies (e.g. MesoScale, EliSpot, BioPlex) Understanding of cell viability and cell potency testing Understanding of the principles of flow cytometry Why People choose to work at Labcorp? At Labcorp, it's our people that make us great - it's what our clients, our partners and, most importantly, what our employees say. Here, you'll have the opportunity to work with extraordinary people with diverse viewpoints. You'll discover your own outstanding potential as we build an even stronger organization with industry leaders from early development to the clinic and beyond. We help our clients develop medicines that improve health and improve lives of their family and friends. Benefits: Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan. Casual, PRN & Part Time employees regularly scheduled to work less than 20 hours are eligible to participate in the 401(k) Plan only. For more detailed information, please click here. Labcorp is proud to be an Equal Opportunity Employer: Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. Additionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law. We encourage all to apply If you are an individual with a disability who needs assistance using our online tools to search and apply for jobs, or needs an accommodation, please visit our accessibility site or contact us at Labcorp Accessibility. For more information about how we collect and store your personal data, please see our Privacy Statement.

Posted 30+ days ago

Pacific Seafood logo
Pacific SeafoodDoral, FL

$55,000 - $75,000 / year

At Pacific Seafood, we do more than just provide the world with the healthiest proteins on the planet. We are an excellence-driven organization committed to being the brand of choice in the marketplace and the employer of choice in the community. We believe in servant leadership, investing in our team members, and rewarding performance. We live by the core values of our Diamond Philosophy: Quality, Teamwork, Productivity, and Excellence-which means consistently doing your best and always striving to do better. Summary: Will plan, coordinate and direct the food safety and value creation quality program designed to ensure continuous production of products consistent with established standards. Responsible for developing and implementing food safety and quality training programs. Will lead the VCQ programs in meeting regulatory requirements and customer's expectation. Key Responsibilities: Responsible for achievement of quality department goals and objectives; strive for continuous improvement on food safety and quality program Implement hazard analysis and Critical Control Points Program (HACCP) Interpret and implement FDA, ODA regulations ensuring HACCP, SSOP, COOL Act standards are met. Establish and maintain GFSI/BRC/SQF standards in order to meet audit requirements. Interact with Regulatory Agencies and third-party auditors; monitor scheduled audits. Develop and implement applicable training. Remain current on all regulatory requirements and law changes. Maintain knowledge on microbiological testing and be familiar with laboratory environment. Oversee the mock recall and recall process, conduct and coordinate procedures and training. Provide support and direction with customer complaint investigations. Perform internal/external audits and inspections to ensure that all standards and requirements are met. Identify, investigate and report on critical quality defects on production processes and products. Determine source of quality variance and specific steps to be taken in correcting the process and product. Ensure systems are in place to make certain that vendors are capable of meeting food safety, quality, and regulatory expectations. Assist facilities and VCQ Managers and offer on-site support to address critical issues; provide necessary training Prepare and submit reports as required. Participate in management and strategic planning meetings in the pursuit of operational excellence. Perform other duties as assigned. What You Bring to Pacific Seafood: Required: Minimum associates degree from an accredited college or university in food science, marine/fishery science, biology, microbiology, or other related discipline; or equivalent combination of education and experience. Preferred: Minimum three years of quality assurance experience with food or seafood industry. Salary Range: $55,000 - $75,000 DOE Total Compensation: At Pacific Seafood, your base wage is only a portion of your overall compensation package. We invest in our Team Members through a comprehensive and attractive total rewards package, including but not limited to: Health insurance benefits options, including medical, prescription, vision, dental, basic group life and short-term disability Flexible spending accounts for health flex and dependent care expenses 401(k) retirement plan options with generous annual company profit sharing match Paid time-off for all regular FT team members to include sick days, paid holidays, vacation, and personal time Employee assistance program providing confidential professional counseling, financial and legal assistance at no charge to team members and immediate family members Product purchase program

Posted 30+ days ago

N logo
National Indemnity CompanyOmaha, NE
Company: NICO National Indemnity Company Want to work for a company with unparalleled financial strength and stability that offers "large company" benefits with an exciting, friendly, and "small company" atmosphere? Our companies, as members of the Berkshire Hathaway group of Insurance Companies, provides opportunities for professionals interested in just that. Software Quality Assurance Specialist Directs and participates in designing, creating, testing, and implementing automated testing to reduce risk and time to value for software products. Acts as a team lead for technical questions related to testing coverage and practices involving product interactions, complex work orders, and functionality of new features within software products. Champions testing and quality mindset within the team. This position will be with National Indemnity Company in Omaha, NE with a hybrid 50% in the office work environment. This position is not eligible for employer visa sponsorship. #LI-Hybrid / #LI-Onsite What will you do? Plan testing (e.g., regression, functional, data validation, system integration, load, or performance tests) for new and existing functionality. Works closely with teams to design testing strategies and integrate testing into the software development lifecycle to execute on test plans. Identifies opportunities to reduce testing time and effort by automating repeatable tests. Executes and implements test cases, working with engineers, product partners, and business stakeholders. Documents and analyzes test results and recommends corrective action. What are we looking for? Bachelor's degree in computer science, information-technology or related field, or equivalent experience. Minimum 3+ years related work experience. Knowledge of Agile methodologies (Scrum, Kanban, etc.) Knowledge of software development practices and procedures Experience working with Selenium, C#, Postman, and related technologies Who would excel in this role? Someone with familiarity with continuous delivery and continuous integration Someone with strong interpersonal skills including conflict resolution skills Someone with insurance industry and product knowledge Experience with application performance monitoring and observability tools. Strong knowledge of agile practices and experience with agile planning tools (e.g. Azure DevOps). We want you to be involved! We offer Employee Resource Groups for volunteering, connecting with others, social gatherings, and professional development. We also regularly seek employees input through companywide surveys. We care about your health and wellbeing! Our Wellness program is integrated into the Company culture with an online wellness portal that offers a year-round, one-stop-shop to manage and track all areas of health, our Omaha office boasts a complimentary state-of-the-art onsite fitness center, and a robust wellness program. Benefits, Perks and more! We offer retirement and savings plan with immediate enrollment with 100% employer match up to 5%, Medical, Dental and Vision for regular, full-time employees and eligible dependents, a dedicated Learning & Development program for employees to grow personally and professionally, 100% upfront Educational Reimbursement program, subsidized downtown parking, competitive time off policies including parental leave, an Employee Assistance program and much more!

Posted 30+ days ago

Activision logo
ActivisionBloomington, MN

$19 - $36 / hour

Job Title: Associate QA Project Lead Requisition ID: R026229 Job Description: The Associate QA Project Lead is responsible for overseeing the day-to-day operations on the test floor, acting as an extension to the assigned QA Project Lead by assisting with the responsibilities of guiding a team of QA Testers through the functionality testing and/or 1st party compliance testing of an Activision product. The Associate QA Project Lead may also be called upon to perform in an acting QA Project Lead role, including organizing and leading the testing effort on assigned pre-release video games as well as being the main point of contact between Production staff, Development teams, and other Activision QA groups. Duties and Responsibilities: Project Management Assists and makes recommendations to the QA Project Lead in overall project management including fielding and assigning out tasks, and tracking test team effectiveness and issues across the project. Assists and makes recommendations to the QA Project Lead with the creation and maintenance, and auditing within DevTest. Assists and makes recommendations to the QA Project Lead with the completion of milestone assessment reports at Alpha & Beta in accordance with QA policies. Collaborates with and makes recommendations to the QA Project Lead in creating informative and accurate daily reports and may be called up to ensure consistent distribution to designated Production and Management staff. Contributes towards the development of effective test plans and performing standard testing on console games to verify proper function, data content, performance, usability/playability, and hardware/software compatibility. Assists in special projects, such as demonstrations, training, surveys, focus groups, etc. Assists in forming and improving QA systems and procedures by making recommendations to Leads, Sr. Leads, and Managers Manages the test team on a day-to-day basis, and occasionally serves as Lead in the QA Project Lead's absence. Database Administration Assists the QA Project Lead with a review of all issues entered by the test teams to ensure bug reports include required information and conform to Activision QA standards. Tracks high severity issues across the project to ensure that they are resolved for submission. Independently reviews and assigns out NMI issues to testers to ensure swift updates to developer and Production questions regarding issues. Assists the QA Project Lead with initial research and evaluation of all disputed ('Not a Bug,' 'Will Not Fix,' & 'Duplicate') issues. Updates the database after each bug sweep. Managing and Mentoring Monitors the defect report database and other platform associated databases. Provides direct supervision of the test team on a day-to-day basis to ensure rapid and accurate completion of assigned tasks. Evaluates tester performance and recommends promotions or remediation plans to the Project Lead. Coaches testers to alleviate any issues that arise. Prepares testers for additional responsibilities, such as Senior QA Testers. Requirements: Technical Proficient with Devtrack & Jira or similar bug tracking database. Able to identify defects in software titles and report defects in a clear and concise manner. Capacity to create and implement innovative testing procedures and materials. Strong working knowledge of most popular console platforms and related peripherals, PC Software/hardware, and Microsoft Office (Outlook, Word, Excel). Has been in a leadership role (Senior QA Tester and/or Acting Associate QA Project Lead). Non-Technical 1+ year of experience working in the Activision QA Department or in a comparable Quality Assurance department. Possesses excellent spoken and written communication skills and be able to work with varied staff members and personalities. Proficient in exercising independent judgment in supervising others and/or making meaningful recommendations to senior managers with respect to decisions concerning personnel and team management. Strong leadership skills and the ability to mentor new employees. Ability to handle high pressure situations and have strong prioritization skills. Must be punctual, proactive, and have a strong work ethic. Able to work in a team environment. Actively communicates a positive, outgoing approach to Quality Assurance. Able to give and accept positive feedback as well as constructive criticism. Must be an avid gamer, with interests in many different genres of games and a passion for developing high quality games. A strong desire to learn and understand the technologies involved in game creation. Our World At Activision, we strive to create the most iconic brands in gaming and entertainment. We're driven by our mission to deliver unrivaled gaming experiences for the world to enjoy, together. We are home to some of the most beloved entertainment franchises including Call of Duty, Crash Bandicoot, Tony Hawk's Pro Skater, and Guitar Hero. As a leading worldwide developer, publisher and distributor of interactive entertainment and products, our "press start" is simple: delight hundreds of millions of players around the world with innovative, fun, thrilling, and engaging entertainment experiences. We're not just looking back at our decades-long legacy; we're forging ahead to keep advancing gameplay with some of the most popular titles and sophisticated technology in the world. We have bold ambitions to create the most inclusive company as we know our success comes from the passionate, creative, and diverse teams within our organization. We're in the business of delivering fun and unforgettable entertainment for our player community to enjoy. And our future opportunities have never been greater - this could be your opportunity to level up. Ready to Activate Your Future? The videogame industry and therefore our business is fast-paced and will continue to evolve. As such, the duties and responsibilities of this role may be changed as directed by the Company at any time to promote and support our business and relationships with industry partners. We love hearing from anyone who is enthusiastic about changing the games industry. Not sure you meet all qualifications? Let us decide! Research shows that women and members of other under-represented groups tend to not apply to jobs when they think they may not meet every qualification, when, in fact, they often do! We are committed to creating a diverse and inclusive environment and strongly encourage you to apply. We are committed to working with and providing reasonable assistance to individuals with physical and mental disabilities. If you are a disabled individual requiring an accommodation to apply for an open position, please email your request to accommodationrequests@activisionblizzard.com. General employment questions cannot be accepted or processed here. Thank you for your interest. We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, gender identity, age, marital status, veteran status, or disability status, among other characteristics. Rewards We provide a suite of benefits that promote physical, emotional and financial well-being for 'Every World' - we've got our employees covered! Subject to eligibility requirements, the Company offers comprehensive benefits including: Medical, dental, vision, health savings account or health reimbursement account, healthcare spending accounts, dependent care spending accounts, life and AD&D insurance, disability insurance; 401(k) with Company match, tuition reimbursement, charitable donation matching; Paid holidays and vacation, paid sick time, floating holidays, compassion and bereavement leaves, parental leave; Mental health & wellbeing programs, fitness programs, free and discounted games, and a variety of other voluntary benefit programs like supplemental life & disability, legal service, ID protection, rental insurance, and others; If the Company requires that you move geographic locations for the job, then you may also be eligible for relocation assistance. Eligibility to participate in these benefits may vary for part time and temporary full-time employees and interns with the Company. You can learn more by visiting https://www.benefitsforeveryworld.com/ . In the U.S., the standard base pay range for this role is $19.23 - $35.58 Hourly. These values reflect the expected base pay range of new hires across all U.S. locations. Ultimately, your specific range and offer will be based on several factors, including relevant experience, performance, and work location. Your Talent Professional can share this role's range details for your local geography during the hiring process. In addition to a competitive base pay, employees in this role may be eligible for incentive compensation. Incentive compensation is not guaranteed. While we strive to provide competitive offers to successful candidates, new hire compensation is negotiable.

Posted 30+ days ago

C logo
ChargePoint Holdings Inc.Campbell, CA

$70,000 - $175,000 / year

Reports To Director, Software QA What You Will Be Doing As a Sr. Software QA Engineer, you will play a critical role on the ChargePoint QA team, ensuring that our product suite meets the highest quality standards. You will collaborate closely with the Cloud and Platform Engineering teams as well as Product Management to develop test plans, identify automation opportunities, and write and execute test cases for ChargePoint's web and mobile applications. This role calls for a team-oriented professional who is an excellent communicator, creative, data-driven, and results-focused. You will also be responsible for validating the integration of various charging platforms with the ChargePoint Cloud. Requirements Bachelor's or Master's in Computer Engineering or Electrical Engineering 5 years of experience in software development/testing field Strong knowledge and experience in software QA methodologies, tools and processes Well versed with both manual and automation testing for web / mobile applications Experience with Python / Java Experience in building and maintaining automation frameworks and test cases for Frontend and API Strong understanding of API fundamentals Possess excellent analytical and troubleshooting skills, must be self-motivated, willing to learn new concepts, technologies and products quickly Working knowledge of SQL and Linux Professional experience with Jenkins, Jira, and Git Outstanding written and verbal communication skills Ability to work independently Knowledge of OCPP (Open Charge Point Protocol) standard, integration and debugging, and Load/Performance testing is a plus Experience using AI in testing and automation is plus Location Campbell, CA ChargePoint is committed to fair and equitable compensation practices. The targeted US salary range for roles at this operating level is $70,000 to $175,000. This range represents base salary and does not reflect equity, benefits or variable pay where applicable. Actual base salaries are based on several factors unique to each candidate, including but not limited to skill set, experience, certifications and specific work location.

Posted 30+ days ago

C logo
Cambia HealthBoise, ID

$86,000 - $141,000 / year

MANAGER QA & REPORTING (HEALTHCARE) Hybrid (In office 3 days/week) within Oregon, Washington, Idaho or Utah Build a career with purpose. Join our Cause to create a person-focused and economically sustainable health care system. Who We Are Looking For: Every day, Cambia's Operations and Compliance Team is living our mission to make health care easier and lives better. The Manager of Quality Assurance And Reporting directs, develops and leads the staff accountable for providing Health Plan Operation Quality Assurance Auditing and Reporting. Accountable for the timely and accurate external corporate reporting for the Blue Cross Blue Shield Association (BCBSA) Local Operations Scorecard (LOS) and Licensee Desk Level Audit (LDLA), as well as Performance Guarantee performance measures. Responsible for the interpretation of LOS, LDLA, and PG policies and regulations and for the implementation of the necessary statistically valid audit procedures to assess these performance measures. May also be responsible for internal high dollar prepay, staff performance auditing activities, external audit support, or compliance audits. Responsible for writing audit programs, evaluating audit results, and reporting to internal Senior Management any quality issues and areas where quality improvement is needed. Primary business contacts include BlueCross BlueShield Association, affiliate Plan LOS or LDLA peers, Member and Provider Experience, Claims, Group and Member Administration, DTS, and Provider Services Division management - all in service of making our members' health journeys easier. If you're a motivated and experienced QA & Reporting Leader looking to make a difference in the healthcare industry, apply for this exciting opportunity today! What You Bring to Cambia: Preferred Key Experience: Experience with AI tools and technologies to enhance productivity and decision-making in professional settings highly desired Qualifications and Certifications: Bachelor's degree in Business, Accounting, Health Care, Management or related field Five years of experience in claims, membership, or customer service activities is desired minimum three years experience in a leadership or supervisory position Equivalent combination of education and experience Skills and Attributes (Not limited to): Ability to communicate effectively, verbally and in writing with all levels of Cambia personnel. Ability to lead and participate in a team environment to achieve department goals and objectives consistent with corporate vision and strategies. Ability to interpret regulations and external reporting requirements, plan for and successfully implement changes in LOS, LDLA, performance guarantee, and staff performance audit requirements, including appropriate sampling methodology, audit oversight, and concise and accurate reporting. Knowledge of audit techniques and statistical sampling methods and procedures including sample sizes, variances, confidence levels, random and stratified sampling, and precision levels. Knowledge of generally accepted auditing procedures and practices, obtained through an auditing course or prior work experience. Knowledge of quality tools and quality improvement methodologies. Demonstrated effective and diplomatic interpersonal skills with all levels of staff and management Demonstrated analytical ability in identifying problems, developing solutions and implementing effective courses of action. Ability to think clearly under pressure and project a professional image at all times. Strong proficiency with personal computer applications including Microsoft Excel, Word, and PowerPoint. What You Will Do at Cambia (Not limited to): Responsible for developing and implementing quality audits throughout Health Plan Operations to ensure that quality service levels are met or exceeded. Prepares and maintains reference manuals and audit programs/procedure guidelines for all Quality Assurance audits and reports. Maintains knowledge of the BlueCross and Blue Shield Association LOS Program, LDLA, and Performance Guarantee Audit measures, standards and reporting procedures. Analyze and report audit results using graphs/trending in order to highlight and prioritize quality improvement opportunities. Identify error trends and work with business areas to reduce repeat errors. Lead cross-functional quality improvement initiatives by collaborating with Claims, GMA, and Member and Provider Experience, and other divisions to implement corrective action plans. Contribute to and/or manage Quality Assurance Audit & Reporting corporate initiatives. Prepare requests for new or changes to existing audit sampling methods and procedures. Tests sampling program changes and directs implementation. Assists with the preparation of the annual budget for the department and monitors monthly operating expenses to ensure they are within budget. Facilitate regular quality review meetings with cross-functional teams to discuss findings, share best practices, and coordinate improvement initiatives. Demonstrate analytical ability in identifying problems, developing solutions and implementing an effective course of action. Help drive the resolution and completion of outstanding Corrective Action Forms (CAF) that involve repeat audit findings. Ensure hiring, performance evaluations, training and employee development promotes improved production and efficiency along with employee satisfaction. Give presentations to staff or management of various departments in such a way as to promote understanding and motivation to improve or maintain corporate performance levels. Direct and evaluate the activities of subordinates to assure work is completed in an effective accurate and timely manner. Responsible for hiring, performance evaluations, training and employee development. Optimize audit processes by leveraging technology where possible. Integrate audit findings into the training and documentation programs to drive continuous improvement. The expected target hiring range for the Mgr QA and Reporting is $92k - $124k is depending on skills, experience, education, and training; relevant licensure / certifications; performance history; and work location. The bonus target for this position is 15% . The current full salary range for this position is $86k / $141k. About Cambia Working at Cambia means being part of a purpose-driven, award-winning culture built on trust and innovation anchored in our 100+ year history. Our caring and supportive colleagues are some of the best and brightest in the industry, innovating together toward sustainable, person-focused health care. Whether we're helping members, lending a hand to a colleague or volunteering in our communities, our compassion, empathy and team spirit always shine through. Why Join the Cambia Team? At Cambia, you can: Work alongside diverse teams building cutting-edge solutions to transform health care. Earn a competitive salary and enjoy generous benefits while doing work that changes lives. Grow your career with a company committed to helping you succeed. Give back to your community by participating in Cambia-supported outreach programs. Connect with colleagues who share similar interests and backgrounds through our employee resource groups. We believe a career at Cambia is more than just a paycheck - and your compensation should be too. Our compensation package includes competitive base pay as well as a market-leading 401(k) with a significant company match, bonus opportunities and more. In exchange for helping members live healthy lives, we offer benefits that empower you to do the same. Just a few highlights include: Medical, dental and vision coverage for employees and their eligible family members, including mental health benefits. Annual employer contribution to a health savings account. Generous paid time off varying by role and tenure in addition to 10 company-paid holidays. Market-leading retirement plan including a company match on employee 401(k) contributions, with a potential discretionary contribution based on company performance (no vesting period). Up to 12 weeks of paid parental time off (eligibility requires 12 months of continuous service with Cambia immediately preceding leave). Award-winning wellness programs that reward you for participation. Employee Assistance Fund for those in need. Commute and parking benefits. Learn more about our benefits. We are happy to offer work from home options for most of our roles. To take advantage of this flexible option, we require employees to have a wired internet connection that is not satellite or cellular and internet service with a minimum upload speed of 5Mb and a minimum download speed of 10 Mb. We are an Equal Opportunity employer dedicated to a drug and tobacco-free workplace. All qualified applicants will receive consideration for employment without regard to race, color, national origin, religion, age, sex, sexual orientation, gender identity, disability, protected veteran status or any other status protected by law. A background check is required. If you need accommodation for any part of the application process because of a medical condition or disability, please email CambiaCareers@cambiahealth.com. Information about how Cambia Health Solutions collects, uses, and discloses information is available in our Privacy Policy.

Posted 30+ days ago

Niagara Bottling logo
Niagara BottlingHoward, PA
At Niagara, we're looking for Team Members who want to be part of achieving our mission to provide our customers the highest quality most affordable bottled water. Consider applying here, if you want to: Work in an entrepreneurial and dynamic environment with a chance to make an impact. Develop lasting relationships with great people. Have the opportunity to build a satisfying career. We offer competitive compensation and benefits packages for our Team Members. Plant QA Manager Administers policies and programs ensuring that organizational products and processes meet established quality standards. Implement quality standards, ensures and executes compliance on every stage of the process. Essential Functions Lead the facility in all Food Safety, Packaging Quality and Product Quality related activities. Serve as the primary plant liaison within the facility for all Company Quality Assurance Initiatives, Niagara Corporate Quality and Third Party Audits Trend analytical data and develop initiatives to improve plant performance against Niagara quality measures and ensure plant compliance with company and regulatory standards Track, analyze, and lead root cause analysis for all quality and customer complaint issues within the plant Ensure compliance and record keeping for all mandated quality checks, testing, sampling and sanitation activities within the plant Monitor the microbiological program; collect and conduct microbiological analysis of product and process samples when necessary Perform water testing equipment evaluations and calibrations Conduct regular reviews of the facility's Pre-requisite Programs, GMP Compliance and Sanitation Compliance Serve as the facility Food Safety Program Coordinator, HACCP Coordinator and SQF Practitioner Manage budgeting, purchasing and inventory of QA operating supplies such as filters, chemicals and lab supplies Monitor the performance and competencies of plant QA staff and provide leadership, coaching, discipline and development as needed Assist the Research & Development team with formulation adjustments, product evaluations, and product launch activities Maintain a safe work environment and support all plant safety programs Assist with weekend and holiday coverage as needed Please note this job description is not designed to contain a comprehensive list of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without prior notice. Qualifications Minimum Qualifications: 6 Years- Experience in Field or similar manufacturing environment 6 Years- Experience in Position 4 Years- Experience managing people/projects experience may include a combination of work experience and education Computer literate with proficiency in, but not limited to: Microsoft Office Applications, Visio, Oracle Business Systems, Infinity QS, etc Detail-Oriented with Excellent Oral and Written Communication Skills Knowledge of water chemistry, microbiological analysis methods, chemical analysis methods, laboratory systems and beverage sanitation practices Demonstrated ability to use data for creative problem solving, experience using statistical software packages Preferred Qualifications: 10+ Years- Experience in Field or similar manufacturing environment 10+ Years- Experience working in Position 6 Years- Experience managing people/projects experience may include a combination of work experience and education Competencies This position embodies the values of Niagara's LIFE competency model, focusing on the following key drivers of success: Lead Like an Owner Manages a safe working environment, accurately documents safety related training, and effectively communicates safety incidents Provides strategic input and oversight to departmental projects Makes data driven decisions and develops sustainable solutions Skilled in reducing costs and managing timelines while prioritizing long run impact over short term wins Makes decisions by putting overall company success first before department/individual success Leads/facilitates discussions to get positive outcomes for the customer Makes strategic decisions which prioritize the needs of the customer over departmental/individual goals InnovACT Continuously evaluates existing programs and processes, and develops new initiatives to increase efficiency and reduce waste Creates, monitors, and responds to departmental performance metrics to drive continuous improvement Communicates a clear vision, organizes resources effectively, and adjusts the strategy as needed when managing change Find a Way Demonstrates ability to think analytically and synthesize complex information Effectively delegates technical tasks to subordinates Works effectively with departments, vendors, and customers to achieve organizational success Identifies opportunities for collaboration in strategic ways Empowered to be Great Makes hiring decisions primarily based on culture fit and attitude, and secondarily based on technical expertise Engages in long term talent planning Provides opportunities for the development of all direct reports Understands, identifies, and addresses conflict within own team and between teams Education Minimum Required: Bachelor's Degree in Food Science/Technology, Chemistry, Microbiology, Engineering or other related field Preferred: Master's Degree in Food Science/Technology, Chemistry, Microbiology, Engineering or other related field Certification/License: Required: N/A Preferred: HACCP Certification Foreign Language Required: None Required Preferred: None Required Benefits https://careers.niagarawater.com/us/en/benefits *Los Angeles County applicants only Qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers, the California Fair Chance Act, and any other applicable local and state laws. Any employment agency, person or entity that submits a résumé into this career site or to a hiring manager does so with the understanding that the applicant's résumé will become the property of Niagara Bottling, LLC. Niagara Bottling, LLC will have the right to hire that applicant at its discretion without any fee owed to the submitting employment agency, person or entity. Employment agencies that have fee agreements with Niagara Bottling, LLC and have been engaged on a search shall submit résumé to the designated Niagara Bottling, LLC recruiter or, upon authorization, submit résumé into this career site to be eligible for placement fees. Niagara Plant Name MILESBURG

Posted 30+ days ago

E logo
Evergreen HealthcareKirkland, WA

$34 - $55 / hour

Description Wage Range: $34.36 - $54.97 per hour NOT a remote position - Kirkland, WA campus Posted wage ranges represent the entire range from minimum to maximum. For jobs with more than one level, the posted range reflects the minimum of the lowest level and the maximum of the highest level. Some positions also offer additional premiums based on shift, certifications or degrees. Job offers are determined based on a candidate's years of relevant experience, level of education and internal equity. Job Summary: Responsible for the quality management system for clinical trials. Utilizes a strong understanding of federal, state, and local regulations, such as ICH-GCP and FDA guidelines. Collaborates with clinical teams, sponsors, and ethics committees to identify and correct deviations and ensure compliance from study startup to closeout. Ensures that clinical trial requirements are met and consistent with the needs and vision of EvergreenHealth. Primary Duties: Plans, conducts, and reports internal and external audits of clinical trial processes, sites, and vendors to assess compliance. Assists with regulatory agency audits (e.g., FDA inspections) and sponsor monitoring visits. Develops and implements corrective and preventive action (CAPA) plans for all audit findings and non-compliance issues. Prepares, reviews, and submits regulatory documents to Institutional Review Boards (IRBs), Ethics Committees, and regulatory agencies like the FDA. Maintains and tracks all regulatory documentation, including the eRegulatory system. Ensures all records are accurate and complete. Reviews and approves study-related documents such as protocols, informed consent forms, and other essential documents for regulatory compliance. Develops, implements, and maintains the organization's quality management system (QMS) and Standard Operating Procedures (SOPs) for clinical research. Provides guidance and training to clinical staff on regulatory requirements and quality standards. Contributes to the identification of risks and quality improvement initiatives. Serves as the primary contact for regulatory-related communications with sponsors and monitors. Prepares and presents QA metrics and reports to management, identifying trends and potential process failures. Performs other duties as assigned. License, Certification, Education or Experience: REQUIRED for the position: Bachelor's Degree in a scientific or health-related field. 3 years of experience in clinical research, quality assurance, or a related regulatory role. Experience in developing metrics and key performance indicators to track study progress and Sponsor/ CRO performance. Ability to effectively establish priorities and develop objectives, goals and action plans to meet or exceed expectations within a fast-paced matrixed environment. Proven ability to manage multiple projects, meet tight deadlines, and perform effectively under pressure. Strong understanding of regulations and GCP requirements for drug development, advanced knowledge of clinical operations and industry standards, and advanced skills partnering with CROs and other third-party vendors. Proficiency with electronic regulatory systems, electronic data capture (EDC) systems, and Clinical Trial Management Systems (CTMS). Proven client-facing relevant experience in healthcare, clinical research, project management, or contract research organizations DESIRED for the position: Certified Clinical Research Professional (CCRP) or Certified Clinical Research Associate (CCRA). Regulatory Affairs Certification (RAC). Benefit Information: Choices that care for you and your family At EvergreenHealth, we appreciate our employees' commitment and contribution to our success. We are proud to offer a suite of quality benefits and resources that are comprehensive, flexible, and competitive to help our staff and their loved ones maintain and improve health and financial well-being. Medical, vision and dental insurance On-demand virtual health care Health Savings Account Flexible Spending Account Life and disability insurance Retirement plans 457(b) and 401(a) with employer contribution) Tuition assistance for undergraduate and graduate degrees Federal Public Service Loan Forgiveness program Paid Time Off/Vacation Extended Illness Bank/Sick Leave Paid holidays Voluntary hospital indemnity insurance Voluntary identity theft protection Voluntary legal insurance Pay in lieu of benefits premium program Free parking Commuter benefits Cafeteria & Gift Shop Discount View a summary of our total rewards available to you as an EvergreenHealth team member by clicking on the link below. EvergreenHealth Benefits Guide

Posted 1 week ago

TransCore logo
TransCoreDover, DE
TransCore (TRN), a subsidiary of ST Engineering, is seeking a full-time Associate QA Specialist to join our Customer Service team in Dover, Delaware.Job Summary: Supports adherence to performance standards and quality measures by providing QA support to the Customer Service Center. Responsible for monitoring calls and auditing accounts/reports and contributing to the development, implementation, and modification of training programs to ensure maximum effectiveness of call center/customer service personnel.Essential Duties and Responsibilities include but are not limited to the following: Quality Assurance Assist in monitoring calls for quality and provide QA results to supervisors.Audit a variety of accounts and reports to ensure compliance and accuracy.Develop audit procedures; track and report results to management staff.Make recommendations to management the areas requiring additional training based upon audit findings.Assist in preparing monthly reports for local contracts.May assist in providing quality-related training to customer service staff. Training and Development: Design and develop new training courses for existing applications, including the preparation of training materials such as manuals, quick reference guides, audio-visual aids, and computer help-screens.Revise and maintain all training documentation to ensure accuracy and relevance.Maintain statistics and records of the training materials and content covered with each group and/or individual trained.Assist in the ongoing improvements and coordinate the delivery of the New Hire Orientation sessions.Track and report training statistics.Assist in managing the ongoing training requirements for the customer service staff.Supervise nesting staff to ensure training continuity and stability of the training program.Identify and retrain staff for improved performance.Coordinate and conduct refresher training sessions with internal and customer staff. Other Duties: Regular and predictable attendance is an essential function of this job.Perform additional duties assigned to support the overall objectives of the department. Required Skills: At least 2 years prior customer service and call center experience.Advanced knowledge in Microsoft word and Excel to create formulas, pivot tables, graphs, and charts.Effective problem solving, written communication, and verbal communication skills.High skilled in analytics and reporting.Document and technical writing. Education: High school diploma or GED required; Associate degree (A.A.) or equivalent from two-year college or technical school preferred Desired Skills: Training experience preferred.1 - 2 years experience in quality control.

Posted 30+ days ago

KBI Biopharma logo
KBI BiopharmaDurham, NC

$54,000 - $92,077 / year

Position Summary: We are seeking a highly motivated QA Manufacturing Specialist I/II at our state-of-the-art commercial manufacturing facility in Patriot Park, Durham, NC. You will have the unique opportunity to help build our site processes and culture as we ramp up to full manufacturing capacity. We embrace KBI's values of learning and growth, high standards, collaboration, and trust and respect to solve problems and continuously improve. As a center of excellence, our site enables real-time quality and process monitoring through paperless records with integrated automation. We are looking for a critical thinker who is comfortable tackling new challenges / unknowns and utilizing a risk-based approach. We hope you join us! Position Responsibilities: Be an on-the-floor quality partner working with the manufacturing team during operations Work with manufacturing and other groups to escalate and resolve deviations and other compliance issues Conduct QA walkthroughs Participate in safety walkthroughs Participate in process improvements Attend relevant meetings in support of manufacturing operations Review electronic batch records and logbooks Provide feedback on facility response for unplanned events Other tasks and projects as assigned Work 12-hour shifts (2-2-3 schedule, day shift) Position Qualifications: MQA Specialist I High School diploma or equivalent. Degree progression preferred. GMP / regulated industry / laboratory experience is required (approximate 1-3 years). Demonstrated ability to work in a team environment. Demonstrated ability to understand the manufacturing process. Ability to perform routine core MQA responsibilities. MQA Specialist II Associate degree / bachelor's degree strongly preferred or appropriate years of experience (approximate 3-5 years). Demonstrated ability to work in a team environment and strong communication skills within all levels of an organization. Demonstrated ability to represent Quality on interdepartmental meetings. Demonstrated knowledge of technical documents. Ability to support internal and external audits. Demonstrated ability to train employees on Quality subjects. Ability to track and trend department metrics Salary Ranges: MQA Specialist I: $54,000 - $74,300 MQA Specialist II: 66,966 - 92,077 Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate's qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, Sabbatical program, 401K matching with 100% vesting in 60 days and employee recognition programs. KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization. KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply. I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary. I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.

Posted 30+ days ago

S logo
SRC Inc.Syracuse, NY

$85,000 - $90,000 / year

SRC, Inc. is currently seeking a detail-oriented Quality Assurance Specialist who thrives in dynamic environments and brings a sharp, pragmatic mindset to our Corrective Action (CA) program. This role demands agility in approach, a collaborative mindset, accountability in execution, and persistent follow-through to transform risks and opportunities into compliant, effective and sustainable improvements. You'll be at the heart of our quality system, working closely with core functional teams to apply critical thinking and basic problem-solving tools that drive meaningful corrective action activities in a timely manner. What You'll Do Lead the CA program with laser-like focus on velocity, execution, clarity and impact Prioritize business risks and opportunities as a core member of the corrective action board Conduct root cause analyses using tools like 5 Whys, Fishbone Diagram, and FMEA Develop and implement CA plans that are effective and feasible within operational constraints Collaborate cross-functionally with Engineering, Manufacturing Operations and Quality teams Lead "lessons learned" reviews to identify and embed knowledge into future processes and training Monitor CA timeliness and effectiveness, holding stakeholders accountable for outcomes Maintain clear, audit-ready CA documentation in compliance with QMS requirements Create, revise, and format work instructions, SOPs, and quality procedures using MS Word Build clear, visual process maps that promote cross-functional understanding using MS Visio Transform CA data into information, metrics, visualizations and reports using MS Excel Communicate quality performance and trends for diverse audiences using MS PowerPoint Foster organizational learning and growth by providing guidance on CA methods, best practices Support internal and external QMS audit activities, and action item tracking What You'll Bring Bachelor's degree in technical or business field 3+ years' experience working in a quality-related role within a technical or manufacturing environment Strong working knowledge of ISO 9001 / AS9100 Standards Effective written and verbal communication skills Practical judgment to balance ideal solutions with real-world constraints Ability to assess and prioritize multiple actions in a fast-moving environment Prior experience with electronic CA systems and quality workflow tools (e.g. ETQ) Enthusiasm, urgency, and collaborative mindset to garner support for CA Confidence, integrity and consistent follow-through to implement change and drive accountability for CA Ways to Stand Out - Preferred Requirements Strong working knowledge of ISO 14001, EU and NATO QMS Standards Strong working knowledge of Deltek Costpoint or Solumina ERP systems Demonstrated structured problem solving (LSS Green Belt, Black Belt certification) Proficiency with business analytics tools, including Power BI What Sets Us Apart? SRC, Inc., a not-for-profit research and development company, combines information, science, technology and ingenuity to solve "impossible" problems in the areas of defense, environment and intelligence. Across our family of companies, we apply bright minds, fresh thinking and relentless determination to deliver innovative products and services that are redefining possible. When you join our team, you'll be a part of something truly meaningful - helping to keep America and its allies safe and strong. You'll collaborate with more than 1,400 engineers, scientists and professionals - with 20 percent of those employees having served in the military - in a highly innovative, inclusive and equitable work environment. You'll receive a competitive salary and comprehensive benefits package that includes four or more weeks of paid time off to start, 10 percent employer contribution toward retirement, and 100 percent tuition support. Total compensation for this role is market competitive. The anticipated salary range for this position based out of Syracuse, NY is estimated at $85,000 to $90,000 annually. The actual salary will vary based on applicant's experience, skills, and abilities, geographic location as well as other business and organizational needs. SRC offers competitive benefit options, for more details please visit our website.

Posted 3 weeks ago

L logo
Legend Biotech CorpRaritan, NJ

$61,454 - $80,656 / year

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide. Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking QA Investigations Lead I as part of the Quality team based in Raritan, NJ. Role Overview The QA Investigation Lead is an exempt level position reporting to the QA Investigation Supervisor within the Raritan Investigation Excellence Team. The QA Investigations Lead is responsible for providing quality oversight and guidance during the investigation of events that occur in the production of a personalized cell therapy product in a sterile GMP environment. The ideal candidate for this role demonstrates the quality mindset to strive for excellence, continuous improvement and ethical conduct in attaining and maintaining the highest levels of quality. Key Responsibilities Ensure the timely completion of high-quality robust investigations with appropriate root cause(s). Ensure appropriate Corrective and Preventative Actions (CAPA's) are developed and implemented. Escalation of events to management that potentially represent significant quality issues or issues resulting in the delay of investigation closure and product release. Support regulatory inspections and audits by ensuring inspection readiness within facility and serving as an SME during the execution of regulatory inspections and audits as needed. Support compliance activities for site Quality Operations in accordance with Legend standards, procedures and cGMPs. Collaborate with site personnel to provide guidance and determine resolution for end-to-end manufacturing issues. Ensure accurate and timely maintenance and review of manufacturing investigations, CAPAs, change controls and complaints. Perform analysis on quality indicating data and identifying trends. Contribute to maintain investigation compliance metrics. Support investigation process improvement initiatives. Job duties performed may require exposure to and handling of biological materials and hazardous chemicals. Able to work independently and also in a collaborative team setting with quality counterparts that include Manufacturing Operations, Operations Technical Support, Maintenance, Supply Chain and Planning. Requirements A minimum of a Bachelor's Degree in Science, Engineering or equivalent technical discipline is required. A minimum of 2-4 years relevant work experience is required. It is preferable that the candidate has experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy. Knowledge of cGMP and GDP regulations and FDA/EU guidance related to manufacture of cell based products Great attention to detail and ability to follow the procedures. The candidate must be highly organized and capable of working in a team environment with a positive attitude under minimal supervision. Excellent organizational skills with the ability to simplify and clearly communicate complex concepts. Excellent verbal, written and presentation capabilities. Ability to summarize and present results, and experience with team-based collaborations is a must. Must be able to interpret problems and effectively determine appropriate resolutions that ensure compliance and minimize risk. Must exhibit strong leadership skills and effectively develop others. Ability to collaborate well with stakeholders, customers and peers. Must exhibit strong decision-making ability and think creatively while maintaining compliance and quality. Must be able to discern the criticality of issues and communicate to management regarding complex issues. Ability to manage conflict and issues that arise with internal or external customers. #Li-BG1 #Li-Hybrid The anticipated base pay range is $61,454-$80,656 USD Benefits We are committed to creating a workplace where employees can thrive - both professionally and personally. To attract and retain top talent in a highly competitive industry, we offer a best-in-class benefits package that supports well-being, financial stability, and long-term career growth. Our offerings are designed to meet the diverse needs of our team members and their families, ensuring they feel valued and supported every step of the way. Highlights include medical, dental, and vision insurance as well as a 401(k)-retirement plan with company match that vest fully on day one. Equity and stock options are available to employees in eligible roles, we offer eight weeks of paid parental leave after just three months of employment, and a paid time off policy that includes 15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, and 3 floating holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs - demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work. EEO Statement Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by applicable law. Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company. Legend may adjust base salary or other discretionary compensation at any time based on individual, team, performance, or market conditions. Legend Biotech maintains a drug-free workplace.

Posted 30+ days ago

McLane Company, Inc. logo
McLane Company, Inc.Carneys Point, NJ

$70,000 - $80,000 / year

Take your career further with McLane! McLane teammates, the driving force behind our success, are diverse professionals who work together seamlessly to keep our operations running smoothly. As a teammate, you will pair your dedication, expertise, and collaborative spirit with your fellow teammates to serve America's most beloved brands. McLane leaders think long-term, act with purpose, and inspire high performance. They lead with accountability, communicate clearly, and drive results through collaboration, innovation, and continuous growth. They empower each teammate to learn from industry leaders, develop their skills, and build lasting connections nationwide. The Safety & QA Special Project Manager uses their knowledge of requirements, regulations, and developments related to quality assurance (QA) and food protection to create and maintain a product protection culture that ensures all operational processes meet QA requirements at all times. They communicate all aspects of safety to the team and ensure that all operational activities are performed in a safe manner. Benefits you can count on: Pay rate: $70,000 to $80,000 per year. This role is also eligible to participate in the annual incentive plan with a target incentive of 12.5% of your base annual salary. Day 1 Benefits: medical, dental, and vision insurance, FSA/HSA, and company-paid life insurance Paid time off begins day one. 401(k) Profit Sharing Plan after 90 days. Additional benefits: pet insurance, maternity/paternity leave, employee assistance programs, discount programs, tuition reimbursement program, and more! What you'll do as a Safety & QA Special Project Manager: Act as a content expert for quality assurance. Must understand all customer QA requirements and relevant government entities. Maintain procedures and training manuals required to ensure compliance with QA requirements. Perform internal mock audits and serve as primary point of contact for all QA audits. Facilitate all federal, state and local inspections of the facility including documentation of the site visit. Conduct internal inspections to ensure that all QA records and logs are properly maintained. Ensure that all operations are in compliance with government regulations and requirements such as DOT, OSHA, and those of local and state agencies. This position has additional duties. Special projects may be assigned at the position supervisor's discretion. Schedule is Monday- Friday from 8:30 am- 5:00 pm. Must be able to work a flexible schedule including nights, weekends and holidays to meet business needs. Qualifications you'll bring as a Safety & QA Special Project Manager: Have a bachelor's degree in a relevant field. Have at least 5 years of warehousing, distribution, QA, and safety experience. Have experience managing, training, and directing large work groups. Have experience with planning and analytical reporting. Be proficient with Microsoft Office programs (Excel, Outlook, Word). This position requires the ability to read, write, and understand English at a level sufficient to perform job-related tasks effectively and safely. This includes understanding work instructions, safety protocols, and communications essential to the role. The requirement is directly related to the nature of the job and ensures compliance with workplace safety and operational standards. Fit the following? We want you here! Teamwork oriented Organized Problem solver Detailed Our roadmap. Our story. We've been forging our path as a leader in the distribution industry since 1894. Building an expansive nationwide network of team members for 130 years has allowed us to stay agile for our clients across the restaurant, retail, and e-commerce industries. We look to the future and are ready to continue making industry-defining moves by embracing the newest technology into our practices, continuing team member training, and emphasizing our people-centered culture. Candidates may be subject to a background check and drug screen, in accordance with applicable laws. All applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. For our complete EEO and Pay Transparency statement, please visit https://www.mclaneco.com/legal/employment/

Posted 3 weeks ago

Unisys logo
UnisysBogota, DC
What success looks like in this role: Brinda ingeniería de aseguramiento de calidad de software (QA) en múltiples aplicaciones y elementos del sistema, con experiencia comprobada en el sector bancario. Define los requisitos de prueba y lidera la creación de planes de prueba de software. Contribuye en revisiones de arquitectura y diseño. Diseña, desarrolla y ejecuta planes de prueba, incluyendo pruebas de rendimiento y pruebas automatizadas. Desarrolla, mejora y mantiene marcos de prueba bien estructurados, escalables y orientados a la automatización. Redacta documentación de alta calidad, identificando y recomendando soluciones a los problemas observados. Evalúa el impacto de nuevas funcionalidades en las pruebas existentes y analiza la viabilidad de probar nuevas características. Identifica, recomienda e implementa mejoras de procesos para optimizar las estrategias de prueba. Apoya a los miembros del equipo en la escritura de scripts, resultados esperados, resultados de pruebas y descripciones de defectos. Prepara y estima el esfuerzo y cronograma, además de elaborar un plan de pruebas integral. Proporciona actualizaciones periódicas de estado propias y del equipo al líder o gerente. Asiste en la creación de planes de capacitación y desarrollo de habilidades para recursos con menor experiencia. #LI-SA1 You will be successful in this role if you have: Ingeniero de sistemas graduado. Inglés tecnico avanzado Experiencia en sector banacario. Unisys is proud to be an equal opportunity employer that considers all qualified applicants without regard to age, caste, citizenship, color, disability, family medical history, family status, ethnicity, gender, gender expression, gender identity, genetic information, marital status, national origin, parental status, pregnancy, race, religion, sex, sexual orientation, transgender status, veteran status or any other category protected by law. This commitment includes our efforts to provide for all those who seek to express interest in employment the opportunity to participate without barriers. If you are a US job seeker unable to review the job opportunities herein, or cannot otherwise complete your expression of interest, without additional assistance and would like to discuss a request for reasonable accommodation, please contact our Global Recruiting organization at GlobalRecruiting@unisys.com or alternatively Toll Free: 888-560-1782 (Prompt 4). US job seekers can find more information about Unisys' EEO commitment here.

Posted 1 week ago

I logo
IlitchDetroit, MI
Build a Bigger, Better, Bolder Future: Imagine working for a company that measures its success based off the growth of its colleagues, a company that invests in its future by investing in you. Little Caesars is a company where our colleagues make an impact. Your Mission: Supports the Quality Assurance function and assigned projects. Using chemistry, microbiology, engineering and other sciences, this position is part of a team responsible for supporting product development and quality assurance for specific product category(s), managing supplier relationships and ensuring compliance to regulatory requirements. The position will work cross-functionally to deliver projects within specified time, cost and quality parameters. This position will exercise discretion and independent judgment in the performance of the job and the proprietary and confidential nature of the position. How You'll Make an Impact: Lead and manage the quality assurance programs, policies and initiatives for specific product category(s). Responsible for developing inspection, testing and quality control procedures, design of quality training programs, investigation of customer complaint issues and facilitation of quality audits. Responsible for managing assigned product category, during corporate product recalls, withdrawals and maintains required documentation. Use chemistry, microbiology, engineering, and other sciences to study the principles underlying the processing and deterioration of foods. Research ways to make processed foods safe, palatable, and healthful. Partner with Purchasing and Research and Development for continuous improvement and cost savings for specific product categories while maintaining and improving quality. Ensure all Food and Drug Administration (FDA), Hazzard Analysis Critical Control Points (HACCP) and Safe Quality Foods (SQF) and all other regulatory requirements are met and maintained. Research and provide recommendations as needed. Implement, maintain and update policies, procedures, specifications and programs that ensure product safety and quality. Determine and recommend best practices in the industry including the best way to process, package, preserve, store and distribute food. Manage supplier relationships relative to quality, food safety issues and innovation for relative product category(s). Identify and resolve supplier food safety and quality issues. Handles all communication of product specification changes through appropriate channels to ensure change management success. Coordinates the receiving and testing of product samples from all distribution centers as per set schedule. Partner with Purchasing and R&D for continuous improvement and cost savings. Performs other duties as assigned by the Director of Quality Assurance. Who You Are: Bachelor's degree in food science, Biology, Chemistry or related discipline or equivalent experience. Minimum of five (5) years Food Technology and Quality Assurance experience in the food industry with experience in one or more of the following: Food chemistries and microbiology HAACP, SQF and British Retail Consortium (BRC) requirements and metrics. FSMA and how it affects suppliers, warehouses and product transport. Knowledge of food industry manufacturing practices and familiarity with FDA and USDA regulations as they pertain to assigned product categories. This will include OSHA lab standards. Ability to communicate effectively with franchisees, vendors and other departments. Ability to communicate complex technical data in an understanding way to a variety of audiences. Ability to establish, document, update and track quality metrics through standardized and accepted process control procedures. Demonstrated accuracy and attention to detail in the documentation of issues, resolutions, root cause, preventive controls and policy changes. Excellent problem-solving and decision-making skills. Demonstrated ability to make sound, business decisions using the best data available. Able to resolve conflicts and gain consensus. Excellent interpersonal and teamwork skills and ability to work cross-functionally with individuals and teams. Demonstrated ability to prioritize and manage multiple, complex projects and initiatives simultaneously with a results-oriented approach. Computer proficiency (Microsoft Office, database, Internet and documentation software required. Sensory abilities for product evaluation. Knowledge/experience in the Quick Service restaurant industry. Masters' degree in Food Science, Biology, Chemistry or related discipline. Where You'll Work: Position requires working in both an office and test kitchen environment. Position requires field work in manufacturing plants. Position will require occasional travel via a variety of transportation modes for field food product testing and research. All items listed above are illustrative and not comprehensive. They are not contractual in nature and are subject to change at the discretion of Little Caesars Enterprises Inc. Little Caesar Enterprises, Inc. is an Equal Employment Opportunity employer. All qualified applicants will receive consideration for employment without regards to that individual's race, color, religion or creed, national origin or ancestry, sex (including pregnancy), sexual orientation, gender identity, age, physical or mental disability, veteran status, genetic information, ethnicity, citizenship, or any other characteristic protected by law. The Company will strive to provide reasonable accommodations to permit qualified applicants who have a need for an accommodation to participate in the hiring process (e.g., accommodations for a job interview) if so requested. This company participates in E-Verify. Click on any of the links below to view or print the full poster. E-Verify and Right to Work. PRIVACY POLICY

Posted 3 days ago

E logo
Exelixis Inc.Alameda, CA

$153,500 - $217,000 / year

SUMMARY/JOB PURPOSE: This key role drives consistency across QA systems and processes for the Clinical QA team, identifying issues and risks, escalating in a timely fashion, and aligning metrics that provide input into a compliance scorecard for Clinical programs. This leader provides insight and partners with both GCP QA staff and Clinical Operations Quality Management (OQM) to address day-to-day clinical trial operations activities focused on deviations, investigations, audit findings and CAPAs. This role operates across all the Clinical project teams and provides training with inspection readiness activities as required. Essential Duties And Responsibilities: Responsible for designing and coordinating a comprehensive view and aligning standards on Quality systems across Clinical Quality Assurance. Assesses current state, identifies gaps, develops an action plan, implements improvements, and monitors the Quality Systems and internal processes related to GCP QA activities Develops, tracks, and manages periodic management reports focused on track and trend data for key Clinical and QA metrics driving the quality health of the GCP activities. Reviews and approves Deviations, and Corrective and Preventive Actions (CAPAs) Partners with other groups including Regulatory Affairs, Clinical Operations, Translational Medicine, regarding compliance issues and provides compliance guidance Maintains knowledge of current Health Authority regulations and standards and informs Clinical Development stakeholders of potential impact on the organization Represents CQA in internal presentations on quality issues, initiatives, and projects Identifies issues and risks and proposes options and solutions, escalating risks in a timely manner. Participates in identifying and implementing process and system improvements Supervisory Responsibilities: None EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education/Experience: Bachelor's degree in science (e.g., biology, chemistry, pharmacy, medical, mathematics, engineering, or a related field) and a minimum of 11 years of relevant experience; or, Master's degree in science (e.g., biology, chemistry, pharmacy, medical, mathematics, engineering, or a related field) and a minimum of 9 years of relevant experience; or, PhD degree in science (e.g., biology, chemistry, pharmacy, medical, mathematics, engineering, or a related field) and a minimum of 5 years of relevant experience; or, Equivalent combination of education and experience. Experience/The Ideal for Successful Entry into Job: Minimum of 10 years relevant experience in pharmaceutical and biotech industries. Experience in Good Clinical Practices highly desired Demonstrated experience in Quality Systems including critical analysis of impact and continuous improvement processes Strong understanding of Quality Risk Management Experience using standard MS Office Knowledge/Skills: Understanding of the drug development process, particularly related to QA oversight of clinical trials Experience in assisting in the development of business strategies, metrics, and continuous improvements Working knowledge of Health Authority rules and regulations Proven ability to manage Quality Systems, assuring completeness and acceptability as defined for GCP. Ability to apply Quality Risk Management in a variety of situations across Quality Systems Ability to influence others as part of a collaborative team and negotiate effective solutions Strong interpersonal and social skills Identifies and implements methods, techniques, procedures, and evaluation criteria to achieve results. Detail-oriented in execution of tasks and processes Implements technical solutions within quality requirements to complex problems. Excellent verbal and written communication skills Exercises judgment within defined procedures and practices to determine appropriate action. Provides insight and analysis of situations or data requires a review of a variety of factors. Working Conditions: Environment: primarily working in laboratories or in office Infrequent travel may be required. #LI-HG1 If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us! Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $153,500 - $217,000 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors. In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year. DISCLAIMER The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job. We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

Posted 30+ days ago

McLane Company, Inc. logo
McLane Company, Inc.Plymouth, MI
Take your career further with McLane! McLane teammates, the driving force behind our success, are diverse professionals who work together seamlessly to keep our operations running smoothly. As a teammate, you will pair your dedication, expertise, and collaborative spirit with your fellow teammates to serve America's most beloved brands. McLane leaders think long-term, act with purpose, and inspire high performance. They lead with accountability, communicate clearly, and drive results through collaboration, innovation, and continuous growth. They empower each teammate to learn from industry leaders, develop their skills, and build lasting connections nationwide. The Safety & QA Special Project Manager uses their knowledge of requirements, regulations, and developments related to quality assurance (QA) and food protection to create and maintain a product protection culture that ensures all operational processes meet QA requirements at all times. They communicate all aspects of safety to the team and ensure that all operational activities are performed in a safe manner. Benefits you can count on: Day 1 Benefits: medical, dental, and vision insurance, FSA/HSA, and company-paid life insurance Paid time off begins day one. 401(k) Profit Sharing Plan after 90 days. Additional benefits: pet insurance, maternity/paternity leave, employee assistance programs, discount programs, tuition reimbursement program, and more! What you'll do as a Safety & QA Special Project Manager: Act as a content expert for quality assurance. Must understand all customer QA requirements and relevant government entities. Maintain procedures and training manuals required to ensure compliance with QA requirements. Perform internal mock audits and serve as primary point of contact for all QA audits. Facilitate all federal, state and local inspections of the facility including documentation of the site visit. Conduct internal inspections to ensure that all QA records and logs are properly maintained. Ensure that all operations are in compliance with government regulations and requirements such as DOT, OSHA, and those of local and state agencies. This position has additional duties. Special projects may be assigned at the position supervisor's discretion. Qualifications you'll bring as a Safety & QA Special Project Manager: Have a bachelor's degree in a relevant field. Have at least 5 years of warehousing, distribution, QA, and safety experience. Have experience managing, training, and directing large work groups. Have experience with planning and analytical reporting. Be proficient with Microsoft Office programs (Excel, Outlook, Word). This position requires the ability to read, write, and understand English at a level sufficient to perform job-related tasks effectively and safely. This includes understanding work instructions, safety protocols, and communications essential to the role. The requirement is directly related to the nature of the job and ensures compliance with workplace safety and operational standards. Fit the following? We want you here! Teamwork oriented Organized Problem solver Detailed Our roadmap. Our story. We've been forging our path as a leader in the distribution industry since 1894. Building an expansive nationwide network of team members for 130 years has allowed us to stay agile for our clients across the restaurant, retail, and e-commerce industries. We look to the future and are ready to continue making industry-defining moves by embracing the newest technology into our practices, continuing team member training, and emphasizing our people-centered culture. Candidates may be subject to a background check and drug screen, in accordance with applicable laws. All applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. For our complete EEO and Pay Transparency statement, please visit https://www.mclaneco.com/legal/employment/

Posted 3 days ago

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PEMCCO Logistic Services LLCBaltimore, MD
Do you have an eye for detail and a passion for ensuring excellence in every deliverable? Join PEMCCO as a QA/QC Reviewer/Senior Consultant, where you'll serve as a senior subject matter expert performing independent quality assurance and control reviews of CPM schedules, claims analyses, and technical documents. In this role, you'll help ensure all work meets rigorous standards and aligns with both client requirements and PEMCCO's quality protocols. PEMCCO, Inc. is an Information Technology and Information Management (IT/IM) services firm. We assist our customers in maximizing existing and emerging technologies to achieve their desired business productivity objectives. Living the Culture and Making It Happen is the motto we live by. We Live the Culture by carrying out the tenets of our Core Values of Loyalty, Integrity, and Commitment to our Customers and Employees every day. We Make It Happen by following Smart Organization Healthy Organization (SOHO) principles for internal and external communications and the successful execution of projects. Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time. Essential Functions Conduct independent reviews of baseline and progress schedules for logic accuracy and completeness. Verify schedule integrity using Acumen Fuse or equivalent QA tools. Audit claims documentation for accuracy and contractual compliance. Mentor and coach project teams on scheduling best practices and standards. Prepare QA summary reports and present findings to the client and PEMCCO leadership. Competencies Deep knowledge of CPM, claims analysis, and QA/QC methodologies. Exceptional analytical, mentoring, and technical‑writing skills. Familiarity with DGS QA procedures, FTA PM guidelines, and state audit protocols. Required Qualifications Bachelor's degree in Engineering or Construction Management. 15+ years of experience in scheduling, QA/QC, or forensic claims analysis. Preferred Qualifications PE, PMP, or PSP certification. Prior QA/QC review experience for DGS or other Maryland agencies. Benefits 15 days of Paid Time Off 11 Paid Holidays Medical, Dental, and Vision Voluntary Short-Term Disability, Life Insurance, Accident, Critical Illness, Hospital Indemnity, Whole Life Plus, Identity Theft, and Law Assure 401(k) Employee Assistance Program (EAP) Compensation $150 - $190 hourly, depending on experience, ability, and capability. The role requires full-time, on-site presence in Baltimore, MD. Candidates must be able to reliably commute; relocation expenses are not provided. PEMCCO, Inc. is an equal-opportunity employer. The Company does not discriminate based on race, color, sex, sexual orientation, gender identity or expression, religion, national origin, age, disability, genetic information, military or veteran status, pregnancy, childbirth, and related medical conditions, or any other characteristics protected by applicable federal, state, or local law.

Posted 30+ days ago

Lonza, Inc. logo

Supervisor, QA Operations - LSA (Night Shift)

Lonza, Inc.Portsmouth, NH

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Job Description

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 Portsmouth, NH. As a Supervisor, QA Operations, you will lead a team of QA On-the-Floor Specialists who provide real-time quality support for GMP-related activities. This role ensures compliance, drives continuous improvement, and acts as a key liaison between Quality and other departments. The shift schedule for this role is subject to change as manufacturing support needs are realized. You will start on a day shift and transition to a night shift as part of the role requirements.

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:

  • Lead and develop a team of QA On-the-Floor Specialists.

  • Oversee training, mentoring, and performance feedback.

  • Review executed batch records in real time on the production floor.

  • Support manufacturing and other departments with quality needs.

  • Manage escalations and make time-sensitive decisions.

  • Represent QA in cross-functional meetings and audits.

  • Drive continuous improvement and alignment across QA functions.

What we are looking for:

  • High school diploma required; bachelor's degree in life sciences preferred.

  • 5-10 years of experience in cGMP environments.

  • Strong knowledge of GMP regulations and quality systems.

  • Excellent communication and leadership skills.

  • Ability to manage priorities and make critical decisions under pressure.

  • Experience mentoring and developing team members.

  • 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.

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