QA Auditor (FDA/GMP/21 CFR)

Job Title: Quality Assurance Auditor Location: Lancaster, SC Schedule: Monday–Friday, 8:30 AM – 5:00 PM Salary: $70,000 – $95,000 + discretionary bonus (up to 12%, prorated first year) Relocation: Full relocation package available (including temporary housing, moving/storage, and paid site visits) 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. Key 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 #J-18808-Ljbffr Astrix Inc.