Senior Analyst, Quality Control
$90,000–$100,000 year
On-siteFremont, California, United States
Fremont, California, United StatesOn-siteFull Time$90,000–$100,000 yearSenior LevelBIOTECHSmall
Full TimeSenior LevelSmallBIOTECH
Job Summary
Conduct analytical and functional testing for raw materials, in-process products, finish goods, and stability samples. Prepare QC reference templates, review test records, and monitor trending data to optimize specifications and processes. Lead investigations on QC failures, document nonconformance resolutions, and create process change documentation for testing deficiencies. Execute equipment SOPs and validations, while collaborating with R&D on test method transfers and implementation. Train lower-level analysts and update QC documents for compliance with ISO 13485 and GMP requirements.
Required Qualifications
- A B.S. in molecular biology, biology, or related field
- 5+ years of experiences in Quality Control or similar environment
- Experience in molecular biology techniques
- Innovative, highly process oriented, detail oriented, organized, and efficient
- Strong team player and self-starter with the ability to work
- Excellent verbal and written communication skills
- Knowledgeable Quality Control process experiences in ISO 13485 and GMP environment
- E-Verify authorization to work in the United States
Desired Qualifications
- Statistical analysis experience a plus
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