QC Microbiology Analyst - 2nd Shift (Env Monitoring)

Regeneron Pharmaceuticals; Rensselaer (IN); Sur place; USD 34 000 - 53 000; Plein temps

Résumé du poste

Regeneron Pharmaceuticals is seeking a QC Microbiology Analyst to perform environmental monitoring and microbiological testing across drug substance and product areas. You will handle gowning/aseptic qualifications, data peer review, and technical writing for SOPs and investigations, working to GMP standards in a fast-paced environment.

The role requires a BS/BA in Microbiology and 12–18+ months of related experience, with potential for on-site growth and collaboration with cross-functional

Qualifications

• BS/BA in Microbiology or a related field.
• 12–18+ months of related GMP experience.
• GMP experience in Microbiology for drug substance or product preferred.
• Level determined by experience and qualifications.

Responsabilités

• 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 and peer review of data.
• Technical writing for SOPs, protocols, reports, trend reports and investigations.
• Develop and drive scientific or business-related improvement ideas.
• Use MS Office, LIMS, Deviation Management Systems and LMS for daily work.

Connaissances

Environmental monitoring

Microbiological testing

Gowning aseptic qualifications

Training

Data review

Technical writing

Formation

BS in Microbiology

Outils

LIMS

Deviation Management Systems

Learning Management Systems

MS Office

Description du poste

Regeneron Pharmaceuticals is seeking a QC Microbiology Analyst to perform environmental monitoring and microbiological testing across drug substance and product areas. You will handle gowning/aseptic qualifications, data peer review, and technical writing for SOPs and investigations, working to GMP standards in a fast-paced environment.

The role requires a BS/BA in Microbiology and 12–18+ months of related experience, with potential for on-site growth and collaboration with cross-functional