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.Key ResponsibilitiesConduct a mock FDA Pre-Approval Inspection (PAI) in alignment with FDA expectationsEvaluate compliance to Good Clinical Practices (GCP) and 21 CFR 210/211 (GMP)Assess inspection readiness, quality systems, and documentation practicesIdentify compliance gaps and potential regulatory risksProvide detailed audit findings and recommendationsPrepare and deliver audit reports per client and SQA standardsCommunicate observations clearly to stakeholders and leadershipRequired QualificationsDirect experience supporting/hosting FDA inspectionsExperience conducting mock FDA inspections or PAI readiness assessmentsStrong 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 expectationsExcellent reporting, communication, and stakeholder engagement skillsWillingness to travel to Indianapolis, IN for a 4-day auditPreferred QualificationsBackground in clinical and commercial pharmaceutical environmentsExperience supporting high-visibility or regulatory-critical auditsLocated in the Midwest U.SNote:SQA is an Equal Opportunity Employer. Employment is based on merit and qualifications, and is not influenced by race, color, religion, gender, national origin, veteran status, disability, age, sexual orientation, gender identity, marital status, or any other legally protected status.This position requires access to ITAR-controlled technical data and/or defense articles. As such, the candidate must be a U.S. citizen or U.S. lawful permanent resident (green card holder) to comply with the International Traffic in Arms Regulations (ITAR). Applicants who do not meet these criteria will not be considered for this role.We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.4-day audit Pay Rate inclusive of preparation, travel, audit execution, reporting, and follow-up.Travel expenses reimbursed at cost with receipts per SQA travel policy.