GCP/GMP Auditor – Former FDA / FDA Inspection Experience (Midwest USA)

For more than 30 years, SQA Services has been a leader in providing managed supplier quality services — including audits, assessments, corrective actions, inspections, remediation, and engineering support — to manufacturers across regulated industries. We deploy experienced auditors across the United States and in over 90 countries to support client and supplier sites on demand.

 

SQA Services is seeking a senior auditor with former FDA experience and direct FDA inspection exposure to support a 4-day mock FDA Pre-Approval Inspection (PAI) in Indianapolis, Indiana.

This engagement will simulate an FDA inspection environment, requiring an auditor who understands FDA expectations, inspection readiness, and compliance risks across GCP and GMP operations. The auditor will play a key role in assessing readiness and identifying gaps prior to a regulatory inspection.

Auditors located in the Midwest U.S. or willing to travel are preferred.

Conduct a mock FDA Pre-Approval Inspection (PAI) in alignment with FDA expectations

Evaluate compliance to Good Clinical Practices (GCP) and 21 CFR 210/211 (GMP)

Assess inspection readiness, quality systems, and documentation practices

Identify compliance gaps and potential regulatory risks

Provide detailed audit findings and recommendations

Prepare and deliver audit reports per client and SQA standards

Communicate observations clearly to stakeholders and leadership

Direct experience supporting/hosting FDA inspections

Experience conducting mock FDA inspections or PAI readiness assessments

Strong experience auditing to GCP and 21 CFR 210/211 (GMP)

Proven ability to conduct regulatory-style audits (PAI readiness or mock FDA inspections)

Strong understanding of FDA inspection processes and expectations

Excellent reporting, communication, and stakeholder engagement skills

Willingness to travel to Indianapolis, IN for a 4-day audit