Quality Control Microbiologist: Regulatory Audits

RXinsider LTD.; Houston (TX); On-site; USD 65,000 - 90,000; Full time

Job summary

Eagle Analytical is seeking a Quality Control Microbiologist to support sterile and non-sterile microbiology testing, ensuring compliance with cGMP, cGLP, ISO 17025, and USP requirements. You will review data, documentation, and quality investigations to maintain data integrity and ongoing regulatory compliance.

Responsibilities include supporting regulatory inspections, audits, and CAPA processes, reviewing test data for sterility, endotoxin, and environmental monitoring, and writing SOPs and

Qualifications

• 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 in regulated ISO 17025, cGMP, cGLP preferred.
• ASQ certification or related quality credentials preferred.
• Strong attention to detail with data integrity and regulatory compliance.

Responsibilities

• Review routine microbiology data, documentation, and quality investigations to ensure compliance with cGMP, cGLP, ISO 17025, A2LA, and USP 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 worksheets, logbooks, and reports.
• Write, review, and approve SOPs, work instructions, forms, and quality records to ensure regulatory compliance and operational consistency.

Skills

Attention to detail

Written and verbal communication

Independent yet collaborative

Microsoft Office proficiency

Electronic document management

ASQ certification

Education

Bachelor's degree in Microbiology, Biology, or related life science

Tools

Microsoft Office Suite

Electronic document management systems

Job description

Eagle Analytical is seeking a Quality Control Microbiologist to support sterile and non-sterile microbiology testing, ensuring compliance with cGMP, cGLP, ISO 17025, and USP requirements. You will review data, documentation, and quality investigations to maintain data integrity and ongoing regulatory compliance.

Responsibilities include supporting regulatory inspections, audits, and CAPA processes, reviewing test data for sterility, endotoxin, and environmental monitoring, and writing SOPs and