Lead, Quality Control
Vericel Corporation
4 hours ago
On-site
Burlington, MA
Operations
Position Summary:
Oversee operations within the QC laboratory, including hiring, training, supervising, developing, and performance planning of staff; provide day-to-day direction to direct reports.
Key Responsibilities:
- Perform and oversee routine testing to support product disposition and lot release.
- Ensure laboratory activities are conducted in compliance with cGMP requirements.
- Execute and/or coordinate lot release testing as required.
- Ensure completion of scheduled daily testing; provide off-hours support as needed.
- Specify, procure, and oversee validation, calibration, and maintenance of laboratory equipment and instrumentation.
- Serve as lead trainer for QC staff on laboratory assays and procedures.
- Act as lead investigator and/or approver for laboratory deviations, errors, and investigations (LIRs, OOS, OOT).
- Develop and implement CAPAs for laboratory investigations and deviations.
- Review and approve raw data for in-process and finished product testing to ensure cGMP compliance.
- Author, review, and maintain SOPs (including periodic reviews and process improvements).
- Provide leadership, direction, and daily oversight to QC staff in alignment with cGMP and quality standards.
- Coach, mentor, and develop team members; manage performance feedback, recognition, and disciplinary actions as needed.
- Ensure staff are appropriately trained and maintain proficiency.
- Collaborate with QC to support lot release, facility, and raw material testing.
- Partner with Validation, Engineering, and Manufacturing to support project timelines without compromising quality.
- Represent QC in cross-functional meetings and internal/external audits.
- Identify, address, and escalate compliance issues as appropriate.
Basic Qualifications:
- Bachelor’s degree or equivalent with 6+ years of QC laboratory experience, or Master’s degree or equivalent with 4+ years.
- Experience coordinating testing across Lot Release, QC Microbiology, and Raw Material Testing.
- Experience with microbial, molecular and/or cell-based assays.
- Experience troubleshooting and investigating assay and equipment issues.
- Experience identifying root cause.
Preferred Qualifications:
- Experience facilitating meetings.
- Familiarity with Deviation Management Systems (e.g., Trackwise).
Working Conditions & Physical Demands:
- Ability to lift 40 lbs.
- May be required to work weekends and provide rotating holiday coverage.
- May be required to gown into classified clean room areas.
- Onsite schedule: Sunday–Thursday in Burlington, MA; may require some days in Cambridge, MA during transition.
Compensation:
- Salary range: $100,000–$108,000 annually. Bonus/incentive pay/equity/benefits may be provided.
Oversee operations within the QC laboratory, including hiring, training, supervising, developing, and performance planning of staff; provide day-to-day direction to direct reports.
Key Responsibilities:
- Perform and oversee routine testing to support product disposition and lot release.
- Ensure laboratory activities are conducted in compliance with cGMP requirements.
- Execute and/or coordinate lot release testing as required.
- Ensure completion of scheduled daily testing; provide off-hours support as needed.
- Specify, procure, and oversee validation, calibration, and maintenance of laboratory equipment and instrumentation.
- Serve as lead trainer for QC staff on laboratory assays and procedures.
- Act as lead investigator and/or approver for laboratory deviations, errors, and investigations (LIRs, OOS, OOT).
- Develop and implement CAPAs for laboratory investigations and deviations.
- Review and approve raw data for in-process and finished product testing to ensure cGMP compliance.
- Author, review, and maintain SOPs (including periodic reviews and process improvements).
- Provide leadership, direction, and daily oversight to QC staff in alignment with cGMP and quality standards.
- Coach, mentor, and develop team members; manage performance feedback, recognition, and disciplinary actions as needed.
- Ensure staff are appropriately trained and maintain proficiency.
- Collaborate with QC to support lot release, facility, and raw material testing.
- Partner with Validation, Engineering, and Manufacturing to support project timelines without compromising quality.
- Represent QC in cross-functional meetings and internal/external audits.
- Identify, address, and escalate compliance issues as appropriate.
Basic Qualifications:
- Bachelor’s degree or equivalent with 6+ years of QC laboratory experience, or Master’s degree or equivalent with 4+ years.
- Experience coordinating testing across Lot Release, QC Microbiology, and Raw Material Testing.
- Experience with microbial, molecular and/or cell-based assays.
- Experience troubleshooting and investigating assay and equipment issues.
- Experience identifying root cause.
Preferred Qualifications:
- Experience facilitating meetings.
- Familiarity with Deviation Management Systems (e.g., Trackwise).
Working Conditions & Physical Demands:
- Ability to lift 40 lbs.
- May be required to work weekends and provide rotating holiday coverage.
- May be required to gown into classified clean room areas.
- Onsite schedule: Sunday–Thursday in Burlington, MA; may require some days in Cambridge, MA during transition.
Compensation:
- Salary range: $100,000–$108,000 annually. Bonus/incentive pay/equity/benefits may be provided.