Quality Control Analyst, I

Role 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.

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

• 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.