Quality Assurance Audit Lead

Merck•Saint Louis, MO

About The Position

Work Your Magic with us! Start your next chapter and join MilliporeSigma. Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us. This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US. Your Role As Quality Specialist Lead Auditor, you will be the lead for our site’s audit program. You will serve as the "face of quality" during customer, regulatory (FDA, ISO, etc.), and internal audits. Beyond the audit room, you will act as a subject matter expert (SME), providing guidance on Quality Management System (QMS) inquiries and ensuring our manufacturing processes remain in a state of continuous compliance.

Requirements

Bachelor's degree in Biology, Chemistry, Biochemistry or other Life Science discipline.
2+ years of Quality experience in a regulated manufacturing environment.

Nice To Haves

Certified Quality Auditor (CQA) or lead Auditor certification (ISO).
Proven track record of leading successful FDA or Notified body inspections.
Deep understanding of Root Cause Analysis (RCA) tools (5 Whys, Fishbone).
Excellent communication, interpersonal, and collaboration skills.
Detail-oriented, organized, and able to manage multiple audits simultaneously.
Problem-solving and analytical skills.

Responsibilities

Lead and manage the end-to-end audit process, including preparation, hosting (front-room/back-room management), and post-audit reporting.
Ensure the site remains compliant with relevant standards (e.g., ISO 9001, ISO 13485, MDSAP, EXCiPACT, 21 CFR Part 820) and serve as the primary liaison with regulatory bodies.
Develop and execute the annual internal audit schedule to identify risks and drive process improvements.
Oversee the lifecycle of audit findings, ensuring robust root cause analysis and timely implementation of Corrective and Preventive Actions.
Provide daily guidance to cross-functional teams (Operations, Engineering, Supply Chain) regarding QMS requirements and documentation standards.
Maintain and report on Quality Performance Indicators (KPIs) related to audit readiness and compliance health.