Lead, Quality Assurance

Vericel Corporation • Cambridge, MA

124d

About The Position

At Vericel Corporation, we are pioneers in advanced cell therapies for sports medicine and severe burn care, transforming patient lives through cutting-edge regenerative medicine. Our commitment to innovation, patient-centered focus, and scientific excellence drives us to develop groundbreaking treatments including MACI (knee cartilage repair), Epicel and Nexobrid (burn care). The QA Lead is 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.

Requirements

• 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.

Nice To Haves

• 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.

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 and escalate 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.
• 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.
• Other duties as assigned.

Benefits

• Cutting-Edge Science: Work with a leading regenerative medicine product that is transforming patient care.
• Career Growth: Be a part of a growing organization with opportunities to expand your impact.
• Collaborative Culture: Work alongside a team of dedicated professionals who are passionate about improving lives.

What This Job Offers

• Job Type: Full-time
• Industry: Miscellaneous Manufacturing
• Education Level: Bachelor's degree