Regulatory QC Microbiology Specialist

Eagle Analytical Services; Houston (TX); On-site; USD 70,000 - 90,000; Full time

Job summary

Eagle Analytical Services is seeking a Quality Control Microbiologist to perform quality review activities supporting sterile and non-sterile microbiological testing. The role ensures data integrity, regulatory compliance, and adherence to cGMP, cGLP, ISO 17025, and USP requirements while supporting audits and continuous improvement across microbiology testing functions.

You will work with laboratory operations to review data, investigations, training materials, and controlled documentation,

Qualifications

• Bachelor's degree in Microbiology or related life science required.
• Experience in sterile and/or non-sterile microbiology testing preferred.
• Knowledge of GMP/GLP and quality documentation practices.
• Prior experience in regulated labs (ISO 17025, cGMP, cGLP) preferred.

Responsibilities

• Ensure compliance with Eagle Analytical policies, 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 OOS, NCR, DV, 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.

Skills

Attention to detail

Regulatory compliance

Communication

Independent work

Cross-functional teamwork

MS Office

Electronic docs

ASQ certification

Education

Bachelor's degree in Microbiology

Bachelor's degree in Biology

Job description

Eagle Analytical Services is seeking a Quality Control Microbiologist to perform quality review activities supporting sterile and non-sterile microbiological testing. The role ensures data integrity, regulatory compliance, and adherence to cGMP, cGLP, ISO 17025, and USP requirements while supporting audits and continuous improvement across microbiology testing functions.

You will work with laboratory operations to review data, investigations, training materials, and controlled documentation,