Quality Control Scientist

Marlborough, Massachusetts
Industry: Scientists / Research / Lab Technician
Job Number: JN -032021-61993

Title: Quality Control Scientist

Location: Marlborough, MA

Job Type: Long Term Contract

 

Responsibilities:

  • 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.

 

Required Skills:

  • 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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