Quality Control Microbiologist — Regulated Lab Compliance

BioSpace; Houston (TX); On-site; USD 70,000 - 100,000; Full time

Job summary

Eagle Analytical seeks a Quality Control Microbiologist to review routine microbiology data and quality investigations, ensuring compliance with cGMP, cGLP, ISO 17025, A2LA, and USP requirements. You will work with laboratory operations to maintain data integrity and drive continuous improvement across microbiology testing functions.

The role involves interpreting regulatory standards, supporting inspections, and preparing audit findings.

Qualifications

• Bachelors degree in Microbiology or related life science.
• Experience in sterile and/or non-sterile microbiology testing preferred.
• Knowledge of cleanroom practices and regulatory requirements.
• Experience with ISO 17025, cGMP, cGLP preferred.
• Strong attention to detail and data integrity.
• Excellent written and verbal communication skills.
• Ability to work independently while collaborating with cross-functional teams.
• ASQ certification preferred.

Responsibilities

• Ensure compliance with policies, SOPs and Quality Management System.
• Interpret and apply ISO 17025, cGMP, cGLP, USP, and A2LA requirements.
• Support regulatory inspections, client audits, and accreditation assessments.
• 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 lab worksheets, logbooks, and reports.
• Maintain accurate and compliant quality records and documentation.
• Review and approve quality investigations (OOS, NCR, DV, CAPA, change controls, customer complaints).
• Evaluate root cause analyses and corrective action plans.
• Prepare audit finding reports and determine corrective actions.
• Support and conduct internal audits of quality systems and microbiology labs.
• Perform routine compliance walk-through audits to ensure regulatory adherence.
• Manage auditing, storage, retention, and control of quality documentation and quarantined materials.
• Write, review, and approve SOPs, work instructions, forms, and quality records.
• Assist in creating and maintaining quality manuals and controlled docs.
• Prepare and maintain training materials.
• Communicate findings, trends, and risks with management.
• Support continuous improvement initiatives related to quality systems and documentation.
• Perform additional duties and projects as assigned.

Skills

Regulatory knowledge

cGMP

cGLP

ISO17025

Data integrity

Documentation

Audits

SOPs

GMP/GLP reviews

Education

Bachelors in Microbiology

Biology

Biochemistry

Molecular Biology

Tools

MS Office

EDMS

QA software

Job description

Eagle Analytical seeks a Quality Control Microbiologist to review routine microbiology data and quality investigations, ensuring compliance with cGMP, cGLP, ISO 17025, A2LA, and USP requirements. You will work with laboratory operations to maintain data integrity and drive continuous improvement across microbiology testing functions.

The role involves interpreting regulatory standards, supporting inspections, and preparing audit findings.