QC Microbiology Analyst: Cleanroom & GMP Testing

Regeneron Pharmaceuticals, Inc (USA); City of Rensselaer (NY); On-site; USD 33,000 - 52,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc (USA) is seeking a QC Microbiology Analyst to perform microbiological assays and environmental monitoring for drug substance and product manufacturing. This role emphasizes routine environmental monitoring, utilities sampling, gowning, and aseptic qualifications, with strong cGMP adherence.

The candidate will contribute to SOPs, protocols, trend reports, and training while maintaining rigorous data review and technical writing.

Qualifications

• BS/BA in Microbiology or related field with 12-18+ months of experience.
• GMP experience in Microbiology related to drug substance or drug product preferred.
• Experience performing environmental monitoring and microbial testing.
• Ability to work in a fast-paced cGMP environment and follow SOPs.

Responsibilities

• Perform routine environmental monitoring for drug substance/product manufacturing areas.
• Conduct utilities sampling and testing, gowning and aseptic qualifications.
• Prepare SOPs, protocols, reports and trend analyses.
• Train employees and perform data peer review.
• Contribute to technical writing such as investigations and change controls.

Skills

Problem solving

Decision making

Communication

Education

BS/BA in Microbiology or related field

Tools

LIMS

Deviation Management Systems

Learning Management Systems

Microsoft Office Suite (Word, Excel, PowerPoint)

Job description

Regeneron Pharmaceuticals, Inc (USA) is seeking a QC Microbiology Analyst to perform microbiological assays and environmental monitoring for drug substance and product manufacturing. This role emphasizes routine environmental monitoring, utilities sampling, gowning, and aseptic qualifications, with strong cGMP adherence.

The candidate will contribute to SOPs, protocols, trend reports, and training while maintaining rigorous data review and technical writing.