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Quality Control Analyst

2 months ago

Gaithersburg, United States Diati Staffing Full time

The Quality Control Senior Analyst is responsible for day to day operations related to release and stability testing, maintaining QC cell culture lines, and writing SOPs, deviations, change controls and CAPAs as part of typical QC operations.


Responsibilities include but are not limited to:

  • Performs GMP release and stability testing in Quality Control
  • Write technical reports and supporting documentation such as deviation, reports, testing protocols, and trend analyses
  • Review of laboratory notebooks, protocols and reports
  • Perform day to day activities for cell propagation used for QC release and stability assays.
  • Participate in technology transfer, method qualification and validation
  • Leading the lab in 5S and routine housekeeping activities
  • Maintain effective communication with other relevant groups, including but not limited to Quality Assurance, Manufacturing and Analytical Development



Minimum requirements:

  • Minimum of a Bachelor's degree or equivalent in a scientific discipline
  • Minimum 8 years of industry experience in a cGMP laboratory, preferably related to biopharmaceutical industry operations
  • Hands on experience performing ELISA in a cGMP environment
  • Hands on experience performing SDS-PAGE in a cGMP environment
  • Working knowledge of Sf9 Insect Cell Culture Procedures and cell-based assays e.g. HS plaque and Rapid Titer assay
  • GxP (regulatory relevant skills and knowledge) GLP/GCP/GMP required
  • Job holder should be a good understanding of relevant regulatory/industry standards and requirements