Job Description

Job Title: GMP Microbiology Analyst

Location: Round Lake, IL (Onsite)

Experience: 5+ years Job Summary

The Microbiology Analyst is responsible for executing microbiological testing activities in a GMP-regulated environment. The role supports routine testing, deviation investigations, and continuous improvement initiatives while ensuring full compliance with regulatory and data integrity requirements.

Key Responsibilities

• Perform routine microbiological testing including environmental monitoring, bioburden testing, endotoxin testing, and sterility testing in accordance with approved GMP procedures.

• Execute sampling, testing, and analysis following established methods and aseptic techniques.

• Accurately document test results in laboratory notebooks, worksheets, and electronic systems in compliance with data integrity and documentation standards.

• Review, verify, and ensure completeness and accuracy of microbiological data.

• Participate in investigations related to microbiological deviations, OOS, OOT, and contamination events.

• Support root cause analysis and contribute to the development and implementation of CAPAs.

• Ensure proper operation, cleaning, calibration, and routine maintenance of microbiology laboratory equipment.

• Follow laboratory safety guidelines and aseptic practices at all times.

• Support internal and external audits, inspections, and regulatory interactions as required.

• Collaborate with QC, QA, and cross-functional teams to resolve microbiology-related issues.

• Contribute to continuous improvement initiatives, including process optimization and laboratory best practices.

Required Qualifications

• Bachelor's degree in Microbiology, Biology, Biotechnology, or a related scientific discipline.

• Hands-on experience working in a GMP-regulated microbiology laboratory.

• Strong understanding of microbiological testing methods and aseptic techniques.

• Knowledge of GMP guidelines and regulatory expectations for microbiology laboratories.

• Experience supporting or leading deviation investigations is required or highly preferred.

Technical Skills

• Environmental monitoring and cleanroom sampling

• Bioburden and endotoxin testing

• Sterility testing

• Aseptic techniques

• Deviation, OOS, and OOT investigations

• GMP documentation and data integrity

• Root cause analysis and CAPA support

Soft Skills

• Strong analytical and problem-solving mindset

• High attention to detail and commitment to compliance

• Ability to work effectively in a team and across functions

• Clear written and verbal communication skills

• Strong sense of ownership and accountability

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