QC Analyst, Microbial (Biotech)

TL;DR

QC Analyst, Microbial (Biotech): Performing microbiological testing and environmental monitoring to support drug product manufacturing with an accent on GMP compliance and data integrity. Focus on executing microbial limits tests, endotoxin analysis, and maintaining laboratory equipment for product release and stability studies.

Location: On-site in Middletown, DE

Company

A global pharmaceutical and biotechnology service provider focusing on drug product manufacturing.

What you will do

• Perform microbial QC testing for drug products, raw materials, and packaging components according to SOPs.
• Conduct environmental monitoring, bioburden, endotoxin, and microbial identification tests.
• Operate, calibrate, and maintain microbiology laboratory equipment in compliance with GMP.
• Record and report test results following ALCOA+ data integrity principles.
• Maintain inspection-ready laboratory records and notify leads of OOS results or deviations.
• Support client and regulatory audits by providing necessary documentation.

Requirements

• Associate or Bachelor’s degree in Microbiology, Biology, or a related scientific discipline.
• 1–3 years of QC microbiology experience in a GMP-regulated pharma or biotech environment (internships considered).
• Working knowledge of microbiological techniques and instrumentation.
• Familiarity with USP <61>, <62>, <85>, <1116>, ICH guidelines, and GMP regulations.
• Must be able to work on-site in Middletown, DE.

Nice to have

• Experience with LIMS, Empower, or other electronic laboratory systems.
• Previous experience working in a CDMO or multi-client environment.
• Ability to be cross-trained across analytical and microbiological testing areas.