EPA GLP Senior Consultant
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 key differences from the client’s current GMP framework, followed by recommendations and a roadmap to support EPA GLP readiness. The engagement is planned in two phases. Phase 1 is approximately 10 hours and includes reviewing current laboratory processes and documentation, defining applicable EPA GLP requirements, confirming scope, objectives, and assessment criteria, and developing a detailed gap-assessment plan. Phase 2 is approximately two days on-site and focuses on the analytical and microbiology laboratories. It includes evaluating laboratory controls, procedures, documentation, quality systems, and GLP-specific requirements; identifying compliance gaps and practical remediation recommendations; and delivering a prioritized summary of findings and next steps.
Responsibilities
- Review current laboratory processes and documentation.
- Define EPA GLP requirements applicable to the client site.
- Confirm the scope, objectives, and assessment criteria for the engagement.
- Develop a detailed plan for the gap assessment.
- Conduct an on-site gap assessment focused on analytical and microbiology laboratories.
- Evaluate laboratory controls, procedures, documentation, quality systems, and GLP-specific requirements.
- Identify compliance gaps and practical remediation recommendations.
- Deliver a prioritized summary of findings and next steps, including recommendations and a roadmap for EPA GLP readiness.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
No Education Listed
