Quality Control Analyst, I

Vericel Corporation • Cambridge, MA

330d

About The Position

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). The Quality Control Analyst I is responsible for performing 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.

Requirements

• 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
• Proficiency in Outlook, MS Word, Excel and lab based data management systems (LIMs) preferred.
• Ability to lift 40 lbs.
• Required to work one day per weekend.
• Ability to work rotating holiday coverage.
• Required to gown into classified manufacturing ISO 7 clean room areas.

Nice To Haves

• Experience with microbiological testing or environmental monitoring preferred.
• Experience in biotech, pharmaceutical or other regulated industry preferred.

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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Miscellaneous Manufacturing
• Education Level: High school or GED