Environmental QC Microbiology Analyst - 2nd Shift

Regeneron Pharmaceuticals, Inc.; United States; On-site; USD 34,000 - 53,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a QC Microbiology Analyst to perform routine environmental monitoring, microbiological testing, and related QC duties in support of drug substance and product manufacturing at our Rensselaer, New York site.

The role involves gowning and aseptic qualifications, data peer review, and technical writing for SOPs, protocols, and investigations, with emphasis on compliance with cGMP/FDA regulations and collaboration with cross-functional teams.

Qualifications

• BS/BA in Microbiology, Biology or related field; 12–18+ months of related experience.
• Prior GMP experience in Microbiology for drug substance or drug product manufacturing is preferred.

Responsibilities

• Environmental monitoring of controlled environments, personnel and clean utilities.
• Microbiological testing and analysis (bioburden, endotoxin, plate enumeration, growth promotion).
• Gowning and aseptic qualifications for personnel.
• Training of employees.
• Peer review of data.
• Technical writing for SOPs, protocols, reports, trend reports, risk assessments, investigations, and change controls.

Skills

Environmental monitoring

Microbiological testing

Gowning & aseptic qualification

Training of employees

Peer review of data

Technical writing

SOP compliance

LIMS familiarity

MS Office

Education

BS/BA in Microbiology or related field

Tools

LIMS

Deviation Management Systems

Learning Management Systems (LMS)

Microsoft Office (Word, Excel, PowerPoint)

Job description

Regeneron Pharmaceuticals, Inc. is seeking a QC Microbiology Analyst to perform routine environmental monitoring, microbiological testing, and related QC duties in support of drug substance and product manufacturing at our Rensselaer, New York site.

The role involves gowning and aseptic qualifications, data peer review, and technical writing for SOPs, protocols, and investigations, with emphasis on compliance with cGMP/FDA regulations and collaboration with cross-functional teams.