Lead, Quality Assurance

1 week ago

Cambridge, United States Vericel Corporation Full time
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 join and 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.
POSITION SUMMARY

Responsible for the oversight of QA activities which include but are not limited to batch record review, media disposition, label issuance, archiving and final product packaging and release activities. The individual must be able to gown into classified manufacturing ISO 7 clean room areas, to conduct inspection of final product.

DUTIES AND RESPONSIBILITIES
  • Perform, as well as ensure that the review of batch records and release of intermediates is performed within required timeframes outlined in SOPs.
  • Responsible for the packaging and final batch disposition.
  • Responsible for inspection of final product within an ISO 7 cleanroom
  • Support day to day operations, including batch record review, label issuance, archiving and verification with supervision oversight and in a timely manner.
  • Follow oral and written procedures for review and release of intermediate and final product.
  • Support projects as a QA resource.
  • Identifies deficiencies and works with cross functional departments to remedy them. Communicate issues that have occurred, resolutions, or discussions with QA team and Management.
  • Identify, address, and/or escalate compliance problems and issues and provides recommendations for process improvements within the department.
  • Become a Qualified Trainer for QA Operations
  • Review of Validation requalification of equipment and reviewing validation discrepancy forms.
  • Write, conduct periodic review and revise Standard Operating Procedures.
  • Provide oversight to QA Specialist I and II and ensuring compliance.
  • Participate in audits and represent QA as an SME for specified areas.
  • Accountable for timely project completions to meet business needs.
  • Independently make decisions on minor issues on behalf of junior staff.
  • Act as QA Reviewer which entails managing deviations/events, CAPAs and tasks within TrackWise. This includes participating in root cause analysis or hosting a root cause analysis meeting.
  • Participate in Change Controls as SMEs and action item owners for QA.
  • Generate, evaluate, and report quarterly event trending metrics. Generate and present metrics for QMR, PPR and Dashboard Reporting.
  • Manage and investigate product complaints.
  • Participate in risk assessments, root cause analysis, and data interpretation.
QUALIFICATIONS, EDUCATION AND EXPERIENCE
  • Bachelor's degree plus a minimum of 4-6 years of industry relevant experience or Master's Degree plus a minimum of 2-4 years of industry relevant experience.
  • Strong interpersonal skills and ability to work in a team environment.
  • Strong written and verbal communication.
  • Strong organization and time management skills.
  • Proficient in MS Office.
  • Working knowledge of cGMP regulations.
Preferred Qualifications:
  • Experience in overseeing a team and projects.
  • 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 and transport up to 30 lbs.
  • Must be able to work one weekend day.
  • Must be able to support rotating holiday coverage.
  • Must be able to gown into classified manufacturing ISO 7 clean room areas, to conduct inspection of final product.
  • Must be able to gown into CNC 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 VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.

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