Quality Control Analyst, I
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). Position Summary: 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. Schedule: This position is in-office Sunday - Thursday.
Requirements
- BS plus 0-2 years’ industry experience in cGMP lab environment, or AS, 2-4 years’ industry experience.
- HS Diploma, 4+ years’ industry experience in cGMP lab environment, or equivalent.
- Basic working knowledge of cGMP regulations and/or lab experience
Nice To Haves
- 1 year of experience in a cGMP lab environment.
- 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.
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.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
Associate degree
Number of Employees
251-500 employees
