Quality Assurance Supervisor
5 days ago
Quality Assurance Supervisor Job Summary
This role will be based in our Cambridge, MA location until our new state-of-the-art facility located in Burlington, MA is ready.
Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top-performing QA professional looking to contribute to a commercial-stage company with an established portfolio of unique advanced cell therapies and specialty biologics.
Reporting directly to Quality Management at Vericel, this is a great opportunity to join a high-growth company with a strong balance sheet supported by a talented team of professionals who are committed to improving the lives of the patients we serve.
Key Responsibilities:
- Lead a team of QA Specialists in the day-to-day Quality Operations activities, including the disposition of in-process materials and final product packaging and release.
- Conduct inspections of final product in classified manufacturing ISO 7 clean room areas.
- Be a quality reviewer for deviations, events, and CAPAs, providing metrics and adherence to timelines.
- Maintain a positive relationship and effectively communicate with other departments to meet company goals.
Requirements:
- Bachelor's degree or equivalent in a related field or the equivalent combination of education and/or experience.
- 5+ years or more of increasingly complex quality assurance or manufacturing experience in the Biotech/Pharmaceutical industry.
- Strong interpersonal skills and ability to work in a team environment.
- Strong written and verbal communication.
- Strong organization and time management.
- Proficient in MS Word, Excel, PowerPoint.
- Through knowledge of cGMP regulations.
- Experience directly managing employees.
Preferred Qualifications:
- Skill and knowledge of and experience with processes involved in manufacturing and distribution, QA, validation, and process development.
- Knowledge of electronic batch records, ERP systems, and Quality Management Systems (TrackWise and Veeva).
- Ability to interpret Quality standards for implementation and review.
Working Conditions and Physical Demands:
- Ability to lift up to 30 lbs.
- Ability to work one weekend day.
- Rotating holiday coverage.
- Ability to gown and gain entry to the manufacturing areas.
EEO Statement:
All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability.
Vericel Corporation is an Equal Opportunity/Affirmative Action Employer.
Vericel Corporation is a VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.
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