QA Auditor (FDA/GMP/21 CFR)

Position Overview

We are seeking an experienced Quality Assurance Auditor to join our team in Lancaster, SC. This role will report directly to the Supplier Quality & Compliance Manager and will play a critical role in supporting and expanding internal and external audit capabilities across suppliers, CMOs, and contract laboratories. This is a highly visible position within QA, responsible for ensuring compliance with FDA regulations and strengthening supplier quality programs.

Responsibilities

• Plan, schedule, and execute internal and external audits to ensure compliance with cGMP and applicable FDA regulations
• Perform supplier/vendor/CMO audits and maintain the Approved Vendor List within the QMS (Qualityze)
• Manage the Supplier Corrective Action Request (SCAR) program and ensure timely closure of audit findings
• Assess audit findings, determine risk levels, and drive effective corrective and preventive actions (CAPA)
• Maintain all audit, vendor, and compliance documentation within the QMS
• Support and enhance the internal compliance program and audit processes
• Track, analyze, and report audit metrics to QA leadership
• Partner cross-functionally to ensure alignment on quality and compliance expectations
• Support regulatory inspection readiness and internal training initiatives
• Travel to supplier sites (domestic and occasional international) for audits

Qualifications

• Bachelor's degree (BS/BA) in a scientific or technical field
• 5+ years of QA auditing experience in a cGMP-regulated environment
• 5+ years of external supplier/vendor auditing experience within an FDA-regulated industry
• Strong knowledge of 21 CFR Parts 210, 211, 507, and 111 (dietary supplements)
• Hands-on experience with both internal and external audits
• Experience managing supplier quality programs, vendor qualification, and audit documentation
• Familiarity with QMS systems (Qualityze preferred) and SAP
• Proficient in Microsoft Office

Preferred Qualifications

• ASQ Certified Quality Auditor (CQA) certification
• Experience auditing CMOs and contract laboratories

Additional Requirements

• Ability to travel 20–30% for domestic supplier audits (with occasional international travel)
• Ability to work in manufacturing and cleanroom environments, including use of required PPE
• Strong communication skills and ability to work across all levels of the organization

Why Join Us?

• High-impact role supporting a growing QA function
• Strong leadership and collaborative team environment
• Competitive compensation + bonus potential
• Comprehensive relocation support