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

We are seeking a highly experienced Subcontractor – Senior OTC Compliance Auditor with a background as a former FDA Investigator/Inspector. This short-term assignment (May-August 2026) requires expertise in OTC drug manufacturing, cGMP compliance, and FDA inspection methodology.

As a subcontractor, you will support audits, inspection readiness activities, and compliance reviews for clients in the OTC pharmaceutical industry. 

Key Responsibilities

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