Quality Control Analyst II

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


DUTIES AND RESPONSIBILITIES

  • 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, EDUCATION AND EXPERIENCE

  • 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.


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.


WORKING CONDITIONS AND PHYSICAL DEMANDS

  • Ability to lift 40 lbs.
  • 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.


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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