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QC Microbiology Analyst III
Laboratory
Fremont, California, US
Pay Rate Low: 32 | Pay Rate High: 34
Pay Rate Low: 32 | Pay Rate High: 34
Our client is a global, research-driven pharmaceutical manufacturer focusing on treatment options for diseases and conditions for which there is no satisfactory treatment option to date. The company is looking for a Sr. QC Associate to join the team. This is an amazing opportunity to work on cutting edge treatments and make a difference!
Title: Sr. Quality Control Associate (Contract)
Location: Alameda County, CA
Schedule & Contract
- Contract Duration: 3-4 months (Likely to extend)
- Schedule: Monday–Friday, 8:00 AM–5:00 PM
- Hours: 40 hours per week
Candidates need to have:
- Microbiology lab including Bioburden testing
- LAL (ENDO) testing
- Aseptic Technique
- Growth promotion testing
- Microbial Identification, etc.
Job Duties
We are seeking a Quality Control Analyst to support analytical testing activities within a cGMP-regulated biopharmaceutical manufacturing environment.
- This role is responsible for executing and coordinating analytical testing of bulk drug substance and drug product across multiple analytical platforms, including chromatography, potency/bioassays, microbiology, raw materials, cleaning validation, and packaging testing.
- The analyst will independently perform and review 3–5 analytical methods, ensure accurate documentation, and support data trending, investigations, and compliance activities.
- Responsibilities include authoring and maintaining QC documentation (SOPs, test methods, specifications, and reports), identifying process improvements, and ensuring adherence to global regulatory requirements (e.g., FDA, EMA).
Qualifications
- High School Diploma with 6+ years, Associate Degree with 4+ years, or Bachelor’s Degree in a science or engineering field with 2+ years of cGMP experience
- Prior Quality Control experience preferred
- Strong technical knowledge of analytical testing in biopharmaceutical manufacturing
- Demonstrated ability to independently execute methods, review data, and ensure compliance.
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QC Microbiology Analyst III
