Senior QA Lead: Microbiology & Quality Systems

EPM Scientific; Blacksburg (VA); Sur place; USD 90 000 - 130 000; Plein temps

Résumé du poste

EPM Scientific is seeking a QA Manager with a microbiology background to support GMP manufacturing and quality systems across the site. You will lead QA oversight for microbiology programs, environmental monitoring, investigations, and CAPA processes.

The role requires a Bachelor's in microbiology or related field and 5+ years in QA/QC within GMP environments, with strong knowledge of FDA/cGMP, deviations, and change controls.

Qualifications

• Bachelor's degree in Microbiology or related life sciences.
• 5+ years in Quality Assurance and/or QC Microbiology in GMP environments.
• Strong understanding of microbiological testing and environmental monitoring.
• Experience with investigations, CAPAs, deviations, and quality systems.
• Knowledge of FDA and cGMP requirements.

Responsabilités

• Provide QA oversight for microbiology programs and environmental monitoring.
• Lead deviations, investigations, CAPAs, and change controls.
• Review and approve quality documentation and GMP records.
• Ensure compliance with cGMP regulations and internal standards.
• Partner with cross-functional teams to drive quality improvements.

Connaissances

QA Leadership

Microbiology

GMP Compliance

Environmental Monitoring

Investigations & CAPAs

Formation

Bachelor's degree in Microbiology or related life sciences

Description du poste

EPM Scientific is seeking a QA Manager with a microbiology background to support GMP manufacturing and quality systems across the site. You will lead QA oversight for microbiology programs, environmental monitoring, investigations, and CAPA processes.

The role requires a Bachelor's in microbiology or related field and 5+ years in QA/QC within GMP environments, with strong knowledge of FDA/cGMP, deviations, and change controls.