Quality Control Analyst, I
Location : Cambridge MA moving to Burlington MA
Duration: 6 month contract to hire
Start : ASAP
Schedule : Monday thru Friday (flex start) 40 hour work week
Salary: $32 to $38/hr based on experience Education:
BS plus 0-2 years’ industry experience in cGMP lab environment, OR AS, 2-4 years’ industry experience OR
HS Diploma, 4+ years’ industry experience in cGMP lab environment, or equivalent Qualification:
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
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).
- Author and conduct periodic review to QC documents, including SOPs, protocols and forms as needed.
- Initiate deviations and lab investigations as needed.
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