Quality Control Microbiologist – Regulatory & Data Integrity

BioSpace; Houston (TX); On-site; USD 65,000 - 90,000; Full time

Job summary

Eagle Analytical is seeking a Quality Control Microbiologist to support both sterile and non-sterile testing by reviewing data, documentation, and investigations to ensure cGMP, cGLP, ISO 17025, A2LA, and USP compliance. The role partners with laboratory operations to maintain data integrity and drive continuous improvement.

The candidate will interpret regulatory standards, support inspections and audits, and contribute to CAPAs and change controls while maintaining accurate quality records

Qualifications

• Bachelor’s degree in Microbiology, Biology, or a related life science.
• Experience in sterile and/or non-sterile microbiology testing preferred.
• Experience in regulated laboratories (ISO 17025, cGMP, cGLP) preferred.

Responsibilities

• Review microbiology data and documentation for sterility, endotoxin, bioburden, microbial limits, environmental monitoring and particulates.
• Ensure compliance with SOPs and the Quality Management System.
• Support regulatory inspections, client audits and accreditation assessments.
• Review and approve quality investigations (OOS, NCR, DV, CAPA, change controls, customer complaints).
• Prepare audit finding reports and determine corrective actions.
• Assist in internal audits of quality systems and microbiology labs.

Skills

Attention to detail

Regulatory compliance knowledge

Written and verbal communication

Independent work with cross-functional

MS Office / EDM systems

Education

Bachelors in Microbiology/Biology/Biochemistry

Tools

Microsoft Office

Electronic document management systems

Job description

Eagle Analytical is seeking a Quality Control Microbiologist to support both sterile and non-sterile testing by reviewing data, documentation, and investigations to ensure cGMP, cGLP, ISO 17025, A2LA, and USP compliance. The role partners with laboratory operations to maintain data integrity and drive continuous improvement.

The candidate will interpret regulatory standards, support inspections and audits, and contribute to CAPAs and change controls while maintaining accurate quality records