QC Analyst Micro
35 Leveroni Ct Novato, CA 94949 US
Job Description
PURPOSEĀ
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. Ā
RESPONSIBILITIES
Duties
- Perform daily environmental monitoring sampling of GMP facilities cleanrooms (Galli and Leveroni manufacturing areas) and utility systems (RODI/WFI/Steam water systems and CDA/process gases.)
- Examine microbial plates daily for quantification and characterization.
- Perform shared general housekeeping activity assignments, including but not limited to, operation of autoclave sterilization of QC testing material, and CTE chart checks.
- Assist with monitoring and the control of laboratory media supply and critical reagent inventories.
- Responsible for continuous upkeep and organizing of QC GMP records.
- Attend team huddles and department meetings, generate ideas for laboratory infrastructure improvements and method optimization.
- Perform other responsibilities as deemed necessary.
Education
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.
Ā
Skills
ā¢ Experience in quality control practices, current Good Manufacturing Practices or Good Laboratory Practices beneficial, but not required.
ā¢ Must possess ability to take initiative. Able to work in team, as well as, on an individual basis.
ā¢ Ability to perform most tasks with supervision.
ā¢ Computer literacy is required.
ā¢ Must have excellent record keeping, written and verbal skills.
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