Quality Control Microbiology Analyst

• Job Title: Quality Control (QC) Microbiology Analyst
• Location: [Marlborough, MA/ On-site]
• Employment Type: Full-Time Hours - 6 month contract assignment to start
• Shift: Sun-Wed First Shift - 5% shift differential

• About the Role
• We are hiring a QC Microbiology Analyst to support our manufacturing operations and laboratory testing workflows. Working in a regulated, cGMP environment, you will be responsible for end-to-end microbiological assays, cleanroom environmental monitoring, and critical utility testing that safeguard product quality and patient safety.

The client is strengthening its presence in Marlborough, Massachusetts, home to a state-of-the-art GMP facility supporting individualized therapy (INT) clinical-to-commercial manufacturing. The Marlborough campus provides end-to-end capabilities—from buffer preparation through drug substance and drug product manufacturing—leveraging automation, robotics, and digital tools to enable robust, scalable operations across our mRNA portfolio.

This role is ideal for a quality-driven laboratory professional with strong aseptic technique, a commitment to data integrity, and an interest in modern lab practices—including digital workflows and emerging lab-support technologies.

• What You’ll Do
• Testing & Sampling: Perform routine and time-sensitive testing, including bioburden, bacterial endotoxin (LAL), sterility, growth promotion, TOC, and conductivity. Execute cleanroom environmental monitoring (EM) and utility sampling.
• Manufacturing Support: Deliver rapid STAT testing support for active manufacturing batches; maintain flexibility to meet operational schedules.
• Systems & Data Integrity: Log samples and test results in LIMS, complete electronic assay sheets, and assist with data trending and statistical analysis.
• Protocol & Method Execution: Support method acquisition, qualification, and re-qualification protocols. Troubleshoot assays, investigate unexpected results, and maintain instrumentation.
• Quality Records & Compliance: Author and review deviations, CAPAs, and change controls. Write and update laboratory SOPs, test methods, and equipment procedures in strict adherence to cGMP and Good Documentation Practices (GDP).
• Lab Readiness & Projects: Manage sample lifecycles, prepare reagents, perform routine maintenance, and maintain audit-ready cleanrooms. Support continuous improvement initiatives, including approved exploratory tools (such as generative AI for lab-support workflows under human oversight).

• What You’ll Bring
• Education: Bachelor’s degree in Microbiology, Biology, Biochemistry, Biotechnology, or a related life sciences discipline.
• Experience: 1–3+ years of direct laboratory experience in a cGMP-regulated biopharmaceutical, pharmaceutical, or medical device setting (QC Microbiology preferred).

Technical Skills:

• Hands-on proficiency with bioburden, endotoxin testing, aseptic technique, and environmental monitoring.
• Practical experience utilizing LIMS, electronic lab notebooks, and quality management systems (QMS).
• Working knowledge of relevant USP/EP compendia and FDA/EMA regulatory guidelines.

Core Competencies:

• Uncompromising adherence to Data Integrity (ALCOA+) principles and GDP.
• Strong technical writing and communication abilities for drafting reports and investigations.
• Flexibility to adapt to shifting production priorities and scheduled STAT testing needs.

• How to Apply
• Click Easy Apply or submit your resume directly through this posting.