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Analyst I, QC Micro

Novato, CA 94949

Posted: 03/21/2023 Employment Type: Contract Job Category: Scientific Job Number: 548076 Is job remote?: No Country: United States

Job Description


The QC Microbiology department is responsible for performing environmental monitoring and microbiological test methods on in-process intermediates and varying stages of drug products under minimal supervision and within cGMP guidelines, to support further manufacturing of commercial and clinical therapeutics.  


  1. Timely facilitation of incoming sample receipt and accessioning flow, decipher batch assignments across all assay types in accordance with agreed upon best practices.
  2. Perform daily bioburden and Total Organic Carbon (TOC) testing of samples collected from GMP facilities, equipment, and utilities.
  3. Routine cleaning and maintenance of QC biological safety cabinet (BSC) and laminar air flow (LAF) hoods.   
  4. Responsible for continuous upkeep and organizing of QC GMP records.
  5. Evaluate completed assay validity, calculate and summarize results, analyze data per expected or specification ranges. Assist with the compilation and verification of trend analysis reports.
  6. Perform shared general housekeeping activity assignments, including operation of autoclave sterilization of QC testing material.
  7. Assist with monitoring and the control of laboratory supply and critical reagent inventories.
  8. Attend team huddles and department meetings, generate ideas for laboratory infrastructure improvements and method optimization.
  9. Perform other responsibilities as deemed necessary.


Bachelor of Science or Bachelor of Arts in a Biological or Biochemical Science with at least 0-2 years of relevant laboratory experience or Associates of Science with at least 4 years of relevant laboratory experience.

  • QC cGMP experience beneficial.
    • Experience in quality control practices, current Good Manufacturing Practices or Good Laboratory Practices.
    • Demonstrated working knowledge related to specific functional activities.
    • Ability to perform most tasks with supervision.
    • Computer literacy is required.
    • Experience with Microsoft Word and Excel required; experience with Access and PowerPoint a plus.
    • Must have excellent record keeping, written and verbal skills.
    • Experienced with microbiological methodologies and a variety of analytical instrumentation; capable of troubleshooting assays. Efficient in scheduling and facilitating the execution of routine and non-routine testing.
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