Quality Assurance Audit Lead

Cell Marque Corporation•St. Louis, MO

About The Position

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.
Excellent communication, interpersonal, and collaboration skills.
Detail-oriented, organized, and able to manage multiple audits simultaneously.
Problem-solving and analytical skills.

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).

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.