Vericel® Corporation

Quality Control Analyst II

Cambridge, MA, US

27 days ago
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Summary

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).


Position Summary:

Responsible for performing routine and complex testing of in-process samples and final products in accordance with SOPs for product release and validation.


Position Scope:

  • Perform maintenance on complex laboratory equipment.
  • Participate in training of less experienced staff.
  • Participate in transfer methods from support groups to the QC laboratory.
  • May perform finished product review and lot release.
  • Perform cell culture microbial and/or molecular assays.
  • Coordinate departmental systems (i.e. inventory, documentation, equipment maintenance).
  • Communicate inter-departmentally and with outside contacts to solve technical issues.
  • Exercise sound judgment and decision making when problem solving.
  • Revise standard operating procedures as needed.
  • Perform deviation and lab investigations as needed.


Qualifications:

  • Associate’s degree plus a minimum 4-5 years of relevant industry experience in CGMP lab environment, or equivalent or bachelor’s degree plus a minimum of 2+ years of relevant industry experience in CGMP lab environment, or equivalent.
  • Master’s Degree plus a minimum 0+ years relevant industry experience in CGMP lab environment, or equivalent.
  • Required to work one day per weekend.
  • Rotating holiday coverage.
  • May carry company issued cell phone for off-shift remote alarm coverage.
  • Required to gown into classified manufacturing ISO 7 clean room areas.
  • Ability to lift 40 lbs.


Preferred Qualifications:

  • Minimum of 1+ years in cell culture, microbial and/or molecular assays.
  • Proficient in Outlook, MS Word, Excel and lab-based data management systems (LIMs).
  • Experience with microbiological testing, biological assays, or environmental monitoring.
  • Experience in a biotech, pharmaceutical or other regulated industry.
  • Experience with PCR based methodology or cell culture methods.
  • Advanced microbiological techniques, disinfectant efficacy, microbial identification, rapid methods, etc.


Why Vericel?

  • 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.


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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