Audit Specialist
$70,000–$100,000 year
On-site · Fishers, Indiana, United States
Job Summary
Audit Specialist with a focus on quality oversight for GMP-regulated manufacturing. Coordinate and facilitate client, regulatory, and corporate audits, serve as primary point of contact for external auditors, gather and compile supporting documentation, review audit observations, and draft timely audit responses. Track CAPAs, maintain audit schedules, prepare for regulatory inspections, and support development and revision of SOPs and templates. Strong communication, organization, and attention to detail across Quality, Manufacturing, Technical Services, Engineering, and Supply Chain to ensure inspection readiness and compliant audit experiences.
Required Qualifications
- Bachelor’s degree in Life Sciences or a related field (equivalent work experience may be considered)
- 2-4 years of experience in a GMP-regulated pharmaceutical, biopharmaceutical, or CDMO environment
- Demonstrated experience supporting or coordinating client, regulatory, or internal quality audits
- Effective oral and written communication skills with the ability to articulate audit findings, observations, and responses clearly and professionally
- Strong organizational skills with the ability to manage multiple audit activities and deadlines simultaneously
- High attention to detail with the ability to review and compile complex documentation accurately
- Ability to remain calm, professional, and composed in fast-paced, high-pressure audit situations
- Knowledge and experience in auditing and applying knowledge of company and customer processes
- Proficiency with Quality Management Systems (QMS) and document management systems
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