Position Summary
The Quality Control Microbiologist performs quality review activities supporting both sterile and non-sterile microbiological testing. This role is responsible for reviewing routine microbiology data, documentation, and quality investigations to ensure compliance with cGMP, cGLP, ISO 17025, A2LA, and USP requirements, as well as Eagle Analytical’s Quality Management System. The position works closely with laboratory operations to maintain data integrity, regulatory compliance, and continuous improvement across microbiology testing functions.
What You Will Do
- Ensure compliance with Eagle Analytical policies, Standard Operating Procedures (SOPs), and the Quality Management System.
- Interpret and apply regulatory and accreditation standards, including ISO 17025, cGMP, cGLP, USP, and A2LA requirements.
- Support regulatory inspections, client audits, and accreditation assessments as required.
- Review microbiological test data and documentation related to sterility, endotoxin, bioburden, microbial limits, environmental monitoring, and particulate matter testing.
- Verify data integrity, accuracy, completeness, and traceability for laboratory worksheets, logbooks, and reports.
- Maintain accurate and compliant quality records and documentation.
- Review and approve quality investigations, including Out-of-Specification (OOS), Nonconformance Reports (NCR), Deviations (DV), Corrective and Preventive Actions (CAPA), change controls, and customer complaints.
- Evaluate root cause analyses and corrective action plans for laboratory and process-related issues.
- Prepare audit finding reports and determine appropriate corrective and preventive actions.
- Support and conduct internal audits of quality systems and microbiology laboratories.
- Perform routine compliance walk-through audits to ensure ongoing adherence to regulatory and quality requirements.
- Manage auditing, storage, retention, and control of quality documentation and quarantined materials.
- Write, review, and approve SOPs, work instructions, forms, and quality records to ensure regulatory compliance and operational consistency.
- Assist in creating and maintaining quality manuals, procedures, and controlled documentation.
- Prepare and maintain quality-related training materials as assigned.
- Communicate findings, trends, and risks with laboratory management and quality leadership.
- Support continuous improvement initiatives related to quality systems, documentation, and laboratory compliance.
- Perform additional duties and special projects as assigned to support quality and regulatory objectives.
Who You Are
- Bachelor’s degree in Microbiology, Biology, or a related life science required.
- Experience in sterile and/or non-sterile microbiology testing preferred.
- Knowledge of cleanroom practices and microbiological testing principles.
- Experience working in a regulated laboratory environment (ISO 17025, cGMP, cGLP) preferred.
- Experience reviewing GMP/GLP documentation and quality investigations preferred.
- Strong attention to detail with a demonstrated commitment to data integrity and regulatory compliance.
- Excellent written and verbal communication skills.
- Ability to work independently while collaborating effectively with cross-functional teams.
- Proficiency in Microsoft Office applications and electronic document management systems.
- ASQ certification or related quality credentials preferred.
Who We Are
Serving customers since 2004, Eagle offers the highest quality in preparation testing for sterility, bacterial endotoxins, microbial detection, beyond-use dating (BUD) determination and active ingredient potency. State-of-the-art equipment, combined with the experience and knowledge of our team, makes Eagle the best choice for all testing needs. The Eagle team is committed not only to performing the best quality control testing, but also working relentlessly with our customers on solutions if tests receive unexpected results.
Learn more at www.eagleanalytical.com.
