FDA Inspection Experience (Midwest USA)

SQA Services•Indianapolis, IN

5d•Onsite

About The Position

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.

Requirements

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
Must be a U.S. citizen or U.S. lawful permanent resident (green card holder) to comply with ITAR regulations.

Nice To Haves

Background in clinical and commercial pharmaceutical environments
Experience supporting high-visibility or regulatory-critical audits
Located in the Midwest U.S.

Responsibilities

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