Quality Control Microbiology Analyst
$24.76 - $38.7 per hourRegeneron
Regeneron seeks a Quality Control Microbiology Analyst to perform microbiological testing and environmental monitoring for biopharmaceutical manufacturing. The role involves routine assays on raw materials, utilities, and drug products in compliance with cGMP and FDA regulations.
Responsibilities
- Perform environmental monitoring of controlled manufacturing areas, personnel, and clean utilities
- Conduct microbiological testing including bioburden, endotoxin, plate enumeration, and growth promotion assays
- Execute gowning and aseptic qualifications for personnel
- Prepare technical documentation including SOPs, protocols, reports, and laboratory investigations
- Train employees and conduct peer review of analytical data
Requirements
- Bachelor's degree in Microbiology, Biology, or related field
- 12–18+ months of related microbiology experience
- Prior GMP experience in drug substance or drug product manufacturing preferred
- Proficiency with Microsoft Office Suite, LIMS, and deviation management systems
- Ability to work in full cleanroom attire and meet physical demands
Compensation: $24.76–$38.70 hourly
Vacancy posted 5 days ago
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