Quality Control Analyst, I

Summary: Vericel Corporation is a pioneer in advanced cell therapies for sports medicine and severe burn care. The Quality Control Analyst I is responsible for performing routine testing of raw materials and drug products within the QC laboratory to ensure compliance with SOPs and cGMP guidelines. 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 Required Qualifications: - 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 Preferred Qualifications: - 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 Required Skills: cGMP regulations, microbiological testing, laboratory data management Important Skills: cell culture assays, environmental monitoring Nice-to-Have Skills: Outlook, MS Word, Excel Benefits: Bonus, Incentive pay, Equity, Benefits