Senior GMP Microbiology Lab Auditor & Consultant

VTI Life Sciences; Mundelein (IL); On-site; USD 120,000 - 180,000; Part time

Job summary

VTI Life Sciences is seeking a Senior GMP Microbiology Laboratory Consultant to assess an in-house laboratory supporting product release and environmental monitoring. This contract role requires deep GMP microbiology expertise and the ability to identify compliance gaps and recommend practical remediation actions.

The consultant will evaluate laboratory operations, documentation, facilities, equipment, and quality systems for cGMP and USP compliance across multiple sites, with strong leadership

Qualifications

• Minimum 10 years in pharma microbiology laboratory experience.
• Experience with product release and environmental monitoring.
• Experience auditing GMP microbiology laboratories and supporting FDA inspections.

Responsibilities

• Conduct comprehensive assessment of microbiology laboratory operations against FDA cGMP and USP requirements.
• Evaluate laboratory organization, staffing, training, and supervision.
• Review microbiological testing related to product release, raw materials, and environmental monitoring.
• Assess method validation, verification, and transfer practices.

Skills

GMP microbiology

regulatory compliance

data integrity

technical writing

stakeholder communication

lab leadership

risk-based remediation

auditing

Education

Bachelor's degree in Microbiology or related

Advanced degree preferred

Job description

VTI Life Sciences is seeking a Senior GMP Microbiology Laboratory Consultant to assess an in-house laboratory supporting product release and environmental monitoring. This contract role requires deep GMP microbiology expertise and the ability to identify compliance gaps and recommend practical remediation actions.

The consultant will evaluate laboratory operations, documentation, facilities, equipment, and quality systems for cGMP and USP compliance across multiple sites, with strong leadership