Quality Control Microbiology Analyst
Regeneron
Regeneron seeks a Quality Control Microbiology Analyst to perform microbiological testing and environmental monitoring for biopharmaceutical manufacturing. The role involves routine assays, product testing, personnel qualifications, and technical documentation in compliance with cGMP and FDA regulations. Responsibilities
Conduct environmental monitoring of controlled manufacturing areas, personnel, and utilities
Perform microbiological testing including bioburden, endotoxin, plate enumeration, and growth promotion assays
Execute gowning and aseptic qualification procedures for personnel
Peer review data and contribute to technical writing of SOPs, protocols, and investigation reports
Train employees and identify process improvement opportunities
Requirements
Bachelor's degree in Microbiology, Biology, or related field
Minimum 12–18 months of related microbiology experience
Prior GMP experience in drug substance or drug product manufacturing preferred
Proficiency with Microsoft Office applications, LIMS, and laboratory management systems
Ability to work Sunday–Wednesday, 2nd shift (1:00 pm–11:30 pm)
Capability to perform physical tasks in cleanroom environment for up to 10 hours
Compensation: $24.76–$38.70 per hour
Vacancy posted more than 2 months ago
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