Job Description
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 of 0+ years relevant industry experience in CGMP lab environment, or equivalent.
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.
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