Job Summary
A laboratory company has an open position for a Telecommute Good Manufacturing Practices Consultant.
Core Responsibilities of this position include:
- Performing onsite GMP compliance audits and/or consultation
- Opening and closing meetings
- Assessing compliance with FDA, EU regulations and guidelines
Skills and Requirements Include:
- Participate in meetings and onsite audits
- BA/BS Chemistry, Biology or related scientific degree with 5-8 years of experience (or equivalent training and experience)
- Minimum of 5 years, actively participating in a GMP lead auditor role and or consulting
- Knowledge in the regulatory standards FDA, ICH, DEA, ISO and GXP
- Experience in GMP FDA Regulations Parts 210-211, 820, 110, 111 and Cosmetic Guidelines
- Experience in international compliance and auditing