QC Analyst (Microbial)

TL;DR

QC Analyst (Microbial): Performing routine and non-routine microbiological laboratory activities in support of drug product manufacturing with an accent on environmental monitoring, bioburden testing, and endotoxin analysis. Focus on maintaining GMP compliance, accurate documentation, and supporting laboratory operations for product release and stability studies.

Location: Must be based in Middletown, DE (On-site)

Company

A global pharmaceutical and biotechnology research and development company providing a broad portfolio of services.

What you will do

• Perform microbial QC testing for drug products, raw materials, and utilities following SOPs.
• Conduct environmental monitoring, bioburden, endotoxin, and microbial identification tests.
• Operate, calibrate, and maintain laboratory equipment in accordance with GMP requirements.
• Record and report test results ensuring strict adherence to data integrity principles.
• Assist in preparing for client and regulatory audits.
• Notify leadership promptly of any deviations or out-of-specification results.

Requirements

• Associate or bachelor’s degree in Microbiology, Biology, or related scientific discipline.
• 1–3 years of QC microbiology experience in a GMP-regulated pharmaceutical or biotechnology environment.
• Working knowledge of microbiological techniques and instrumentation.
• Familiarity with GMP regulations, USP guidelines, and data integrity principles.

Nice to have

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