Quality Control Analyst

• 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.

Leadership Responsibilities:

• Understanding, observing, and adhering to the goals and policies outlined in Code of Business Conduct and Ethics.
• Being honest and treating people with respect and courtesy.
• Constantly striving to make us a great place to work, and a company respected for the quality of its people and products.
• Serving as role models for our fellow employees and business partners by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

• HS Diploma, 4+ years’ industry experience in cGMP lab environment, or equivalent.
• AS/BS degree in microbiology, molecular biology, biochemistry or a related discipline. AS, 2-4 years’ industry experience. BS, 0-2 years’ industry experience in cGMP lab environment, or equivalent.

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

• Ability to lift 40 lbs.
• Required to work one day per weekend when converts to perm
• 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