Quality Control Analyst, II
Vericel Corporation
4 hours ago
On-site
Burlington, MA
Operations
Schedule:
- Onsite 5 days/week in Burlington, MA; may need to work some days in Cambridge, MA during transition.
- Shifts: Tuesday–Saturday and Sunday–Thursday.
Position Summary:
- Perform 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.
Position Scope / Responsibilities:
- Perform routine QC testing for raw materials, in-process, DP, and stability samples using balances, pipettes, pH meter, UV/Visible spectrophotometer, plate reader, etc. per SOPs and cGMP.
- Perform cell culture, microbial and/or molecular assays.
- Perform Environmental Monitoring and utilities testing.
- Perform microbial limits and bioburden testing; identify and trend microorganisms.
- Assist in review of QC data and provide summaries to management as needed.
- Report out-of-specification (OOS) or out-of-trend results in a timely manner.
- Calibrate and maintain QC general laboratory equipment; perform housekeeping; prepare lab for audits.
- Train less experienced staff.
- Participate in method transfers to the QC laboratory.
- Coordinate departmental systems (inventory, documentation, equipment maintenance).
- Communicate inter-departmentally and with external contacts to solve technical issues.
- Use sound judgment in problem-solving.
- Author and conduct periodic review of QC documents (SOPs, protocols, forms as needed).
- Perform deviations and lab investigations as needed.
- Practice safe work habits and adhere to safety procedures.
- Other duties as assigned.
Qualifications:
- HS Diploma and 6+ years’ industry experience in a cGMP lab environment (or equivalent).
- Degree in microbiology, molecular biology, biochemistry, or related discipline:
- AS: 4–5 years’ industry experience
- BS: 3+ years’ industry experience
- MS: 0–1 year’s industry experience in a cGMP lab environment (or equivalent).
Preferred Qualifications / Skills:
- 1+ year in cell culture and microbial and/or molecular assays.
- Proficient in Outlook, MS Word, Excel, and lab data systems (LIMS).
- Experience with microbiological testing, biological assays, or environmental monitoring.
- Experience in a biotech/pharma/other regulated industry.
- Experience with PCR-based methodology or cell culture methods.
- Advanced microbiological techniques (e.g., disinfectant efficacy), microbial identification, rapid methods, etc.
Compensation:
- Salary range: $33.65–$38.46 per hour.
- Actual pay may vary based on qualifications, experience, and skills; bonus/incentive pay, equity, and benefits may be provided in addition to base compensation.
- Onsite 5 days/week in Burlington, MA; may need to work some days in Cambridge, MA during transition.
- Shifts: Tuesday–Saturday and Sunday–Thursday.
Position Summary:
- Perform 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.
Position Scope / Responsibilities:
- Perform routine QC testing for raw materials, in-process, DP, and stability samples using balances, pipettes, pH meter, UV/Visible spectrophotometer, plate reader, etc. per SOPs and cGMP.
- Perform cell culture, microbial and/or molecular assays.
- Perform Environmental Monitoring and utilities testing.
- Perform microbial limits and bioburden testing; identify and trend microorganisms.
- Assist in review of QC data and provide summaries to management as needed.
- Report out-of-specification (OOS) or out-of-trend results in a timely manner.
- Calibrate and maintain QC general laboratory equipment; perform housekeeping; prepare lab for audits.
- Train less experienced staff.
- Participate in method transfers to the QC laboratory.
- Coordinate departmental systems (inventory, documentation, equipment maintenance).
- Communicate inter-departmentally and with external contacts to solve technical issues.
- Use sound judgment in problem-solving.
- Author and conduct periodic review of QC documents (SOPs, protocols, forms as needed).
- Perform deviations and lab investigations as needed.
- Practice safe work habits and adhere to safety procedures.
- Other duties as assigned.
Qualifications:
- HS Diploma and 6+ years’ industry experience in a cGMP lab environment (or equivalent).
- Degree in microbiology, molecular biology, biochemistry, or related discipline:
- AS: 4–5 years’ industry experience
- BS: 3+ years’ industry experience
- MS: 0–1 year’s industry experience in a cGMP lab environment (or equivalent).
Preferred Qualifications / Skills:
- 1+ year in cell culture and microbial and/or molecular assays.
- Proficient in Outlook, MS Word, Excel, and lab data systems (LIMS).
- Experience with microbiological testing, biological assays, or environmental monitoring.
- Experience in a biotech/pharma/other regulated industry.
- Experience with PCR-based methodology or cell culture methods.
- Advanced microbiological techniques (e.g., disinfectant efficacy), microbial identification, rapid methods, etc.
Compensation:
- Salary range: $33.65–$38.46 per hour.
- Actual pay may vary based on qualifications, experience, and skills; bonus/incentive pay, equity, and benefits may be provided in addition to base compensation.