QC Biochemist Analyst

2 weeks ago

Pennington, United States MRINetwork Jobs Full time
Job DescriptionJob Description

QC Biochemistry Analyst--Contract - Trenton Metro Area

Duties: Perform QC biochemistry laboratory assay validation and transfer activities to support GMP manufacturing, testing and release of material, intermediates and finished products under FDA/EU regulations, applicable International Regulations, and client's processes and procedures.

Essential Functions of the job:

  • Perform QC biochemistry assay validation and transfer activities, including testing (e.g., DS, DP release and stability testing) to ensure timely generation and reporting of test results in support of manufacturing operations.
  • Support routine operations, including but not limited to instrument qualification and maintenance, SOP generation and revision, testing record keeping, etc.
  • Manage inventory of reagents and supplies for the laboratory.
  • Lead investigations of OOS, discrepancies, errors, failures requiring documented review and action.
  • Participate in internal and external GMP audits where possible.
  • Lead method transfer and method validation activities, prepare protocols and reports.
  • Train other junior level analysts and new hires.
  • Subject matter expert in one or more areas of required testing.
  • Undertake any other duties as required.

Education Required:

Minimum of 2+ years with a bachelor’s or above in Biochemistry, Molecular biology, Biology, or Biotechnology-related scientific discipline. 5+ years of experience preferred.

Experience:
Experience in an FDA-regulated biotechnology, pharmaceutical company, GMP audits and MS Office

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