Contract Opportunity - Senior OTC Compliance Auditor (Great opportunity for former FDA Inspectors)

📋 Description

• Conduct cGMP compliance audits of OTC drug manufacturing, packaging, labeling, and laboratory
• Apply FDA inspection methodology to identify compliance gaps, risks, and deficiencies.
• Prepare detailed, professional audit reports outlining observations and recommended corrective
• Support clients with mock FDA inspections, inspection readiness activities, and compliance
• Review quality systems, SOPs, batch records, data integrity controls, and laboratory practices.
• Represent the organization professionally during international client engagements.

🎯 Requirements

• Former FDA Investigator/Inspector (required).
• 3–5 years of auditing experience within OTC or pharmaceutical manufacturing.
• Strong understanding of cGMP requirements, OTC monograph expectations, and FDA enforcement
• Proven ability to conduct independent, high-level audits and articulate findings clearly.
• Excellent communication and technical writing skills.
• Must be willing and able to travel internationally, outside of North America, for the duration of