Work Location: St. Louis, Missouri
Shift: No
Department: LS-SC-USQS QA System & Compliance
Recruiter: Ashley Hennessy
Hiring Manager: Cheryl Benway Prichard
This information is for internals only. Please do not share outside of the organization.
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.
- 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.
Who You Are
Minimum Qualifications:
- Bachelor's degree in Biology, Chemistry, Biochemistry or other Life Science discipline.
- 2+ years of Quality experience in a regulated manufacturing environment.
Preferred Qualifications:
- 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.
RSREMD
- Pay Range for this position: $66,800.00- $110,300.00.
- The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here.
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.