QC Microbiology Analyst: Bioburden & Endotoxin Testing

ProKatchers LLC; Westborough (MA); On-site; USD 50,000 - 70,000; Full time

Job summary

A leading healthcare staffing company is seeking an Analyst I to support Quality Control Microbiological testing for drug substances and raw materials. Responsibilities include performing QC tests and supporting cleanroom qualifications. The ideal candidate should have experience in environmental monitoring and a background in the pharmaceutical industry. This role is crucial for ensuring compliance with cGMP and GLP guidelines, contributing to clinical development and commercial programs.

Qualifications

• Experience in Environmental Monitoring and Pharma experience required.

Responsibilities

• Support Quality Control Microbiological testing of drug substances and raw materials.
• Perform QC testing for bioburden, microbial identification, and Endotoxin analysis.
• Support cleanroom and gowning qualification for manufacturing activities.

Job description

• The primary purpose of the Analyst I position is to Support Quality Control Microbiological testing of drug substances, raw materials and process intermediates in support of clinical development and commercial programs under cGMP and GLP guidelines, address excursions and conduct investigations.
• Perform QC testing of samples for bioburden, microbial identification, growth promotion, and Endotoxin analysis.
• Support cleanroom qualification, gowning qualification, aseptic process qualification, and personnel monitoring for manufacturing activities.
• Experience in Environmental Monitoring and Pharma experience required