Quality Control Analyst, II

Position Summary

Responsible for performing routine and non-routine assays of raw materials, in-process samples, drug product (DP), and stability samples within the QC laboratory in accordance with SOPs for product release and validation.

Schedule

This position is onsite Sunday - Thursday in our new Burlington, MA office, but will be required to spend some days in our Cambridge office as we transition to our new facility.

Position Scope

• 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 identify and trend microorganisms.
• Auxiliary 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.
• Perform QC general laboratory equipment calibration and maintenance, laboratory housekeeping and preparation of the laboratory for audits.
• Participate in training of less experienced staff.
• Participate in transfer methods from support groups to the QC laboratory.
• Cookordination 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.
• Practice safe work habits and adhere to Vericel’s safety procedures and guidelines.

Qualifications

• HS Diploma, 6+ years’ industry experience in cGMP lab environment, or equivalent.
• Degree in microbiology, molecular biology, biochemistry or a related discipline. AS plus 4-5 years’ industry experience.
• BS plus 3+ years’ industry experience.
• MS plus 0-1 years’ industry experience in cGMP lab environment, or equivalent.

Preferred Qualifications

• Minimum of 1+ years in cell culture, microbial and/or molecular assays.
• Proficient in Outlook, MS Word, Excel and lab based data management systems (LIMs).
• Experience with microbiological testing, biological assays, or environmental monitoring.
• Experience in a biotech, pharmaceutical or other regulated industry.
• Experience with PCR based methodology or cell culture methods.
• Advanced microbiological techniques, disinfectant efficacy, microbial identification, rapid methods, etc.

Benefits

The salary range Vericel reasonably and in good faith expects to pay for this position at the time of this posting is $33.65 to $38.46 hourly. The actual salary offered will be determined based on factors such as the candidate’s qualifications, experience, and skills. Bonus, incentive pay, equity and benefits may be provided in addition to the base compensation listed above.