Quality Control Analyst, I

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 to perform routine testing of raw materials, in-process, drug product (DP) and stability samples within the QC laboratory in accordance with SOPs for product release and validation. DUTIES AND RESPONSIBILITIES Perform routine QC testing for raw materials, in-process, DP, and stability samples using equipment such as balances, pipettes, pH meter, UV/Visible spectrophotometer, plate reader, etc. in accordance with SOPs and cGMP guidelines. Perform cell culture microbial and/or molecular assays. Perform routine Environmental Monitoring and utilities testing. Perform microbial limits, Bioburden testing, and identifying and trending microorganisms. Lab support including but not limited to glass washing, autoclaving, etc. Assist in the review of QC data and provide summaries to management as needed. Report out-of-specification or out-of-trend results in a timely manner to ensure appropriate actions are taken. Performance of QC general laboratory equipment calibration and maintenance, laboratory housekeeping and preparation of the laboratory for audits. Participate in transfer methods from support groups to the QC laboratory. 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. Author and conduct periodic review to QC documents, including SOPs, protocols and forms as needed. Initiate deviations and lab investigations as needed. Practice safe work habits and adheres to Vericel's safety procedures and guidelines. Other duties as assigned. QUALIFICATIONS, EDUCATION AND EXPERIENCE HS Diploma with 4+ years' industry experience in cGMP lab environment, or Associate's degree in microbiology, molecular biology, biochemistry or a related discipline plus 2-4 years' industry experience or Bachelor's degree with 0-2 years' industry experience in cGMP lab environment Basic working knowledge of cGMP regulations Preferred Qualifications: Proficient in Outlook, MS Word, Excel and lab based data management systems (LIMs). Experience with microbiological testing or environmental monitoring Experience in biotech, pharmaceutical or other regulated industry 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.

Created: 2024-11-02