Quality Control Scientist
Posted on: April 8, 2021
Industry: Scientists / Research / Lab Technician
Job Number: JN -042021-62402
Title: Quality Control Scientist
Location: Marlborough, MA
Job Type: Long Term Contract
- Perform routine in-process and release QC testing of cell products.
- Execute analytical method validations and transfers including drafting technical protocols, reports and troubleshooting.
- Maintain, calibrate and operate equipment and instruments supporting cell bioassays, Flow Cytometry, ELISA and PCR assays.
- Track and test products according to stability protocols.
- Work with internal and external resources to maintain lab in an optimal state.
- Monitor and trend data, complete routine record review of test data and related documents for in-process testing, drug substance and drug product release.
- Develop, revise and review SOPs, qualification/validation protocols and reports.
- Conduct investigations regarding out of specifications (OOS) results. Address and manage deviations related to analytical procedures.
- Monitor the GMP systems currently in place to ensure compliance with documented policies. Perform other lab duties as required.
- Bachelor or Master’s degree in biotechnology or related field with 5+ years of Quality Control experience.
- Knowledge of GMP, SOP’s and quality control process
- Experience in the biotech and/or pharmaceutical industry.
- Ability to work weekends.
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