EPA GLP Senior Consultant

ProPharma Group • Raleigh, NC

3d

About The Position

ProPharma is seeking an EPA GLP Senior Consultant to provide a client with an initial consultation and a focused gap assessment of its analytical chemistry and microbiology laboratories. The work will provide a practical, plain-language overview of EPA GLP requirements and explain key differences from the client’s current GMP framework. The consultant will also recommend a roadmap to support EPA GLP readiness.

The engagement is planned in two phases. Phase 1, approximately 10 hours, involves reviewing current laboratory processes and documentation, defining the EPA GLP requirements applicable to the site, confirming scope, objectives, and assessment criteria, and developing a detailed gap-assessment plan. Phase 2, approximately two days on-site, focuses on the analytical and microbiology laboratories. It evaluates laboratory controls, procedures, documentation, quality systems, and GLP-specific requirements, identifies compliance gaps, and provides practical remediation recommendations and a prioritized summary of findings and next steps.

Responsibilities

• Review current laboratory processes and documentation.
• Define the EPA GLP requirements applicable to the site.
• Confirm the scope, objectives, and assessment criteria for the engagement.
• Develop a detailed plan for the gap assessment.
• Assess the analytical chemistry and microbiology laboratories, including their controls, procedures, documentation, quality systems, and GLP-specific requirements.
• Identify compliance gaps and provide practical remediation recommendations.
• Deliver a prioritized summary of findings and next steps.
• Provide an overview of EPA GLP requirements and key differences from the current GMP framework.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed