Analyst I

Analyst I, QC Micro

Novato, CA

12 Months

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.

RESPONSIBILITIES

Schedule (4 days/10 hours):

Sunday - Wednesday, swing shift (11:00am - 10:00pm) or

Wednesday - Saturday, swing shift (11:00am - 10:00pm)

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.

Skills

Experience in quality control practices, current Good Manufacturing Practices or Good Laboratory Practices beneficial, but not required.

Must possess ability to take initiative. Able to work in team, as well as, on an individual basis.

Ability to perform most tasks with supervision.

Computer literacy is required.

Must have excellent record keeping, written and verbal skills.

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.