QA Auditor (FDA/GMP/21 CFR)

QA Auditor (FDA/GMP/21 CFR)Quality AssuranceLancaster , South Carolina, USAdded - 18/05/2026Job Title: Quality Assurance AuditorLocation: Lancaster, SCSchedule: Monday-Friday, 8:30 AM - 5:00 PMSalary: $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 OverviewWe 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 ResponsibilitiesPlan, schedule, and execute internal and external audits to ensure compliance with cGMP and applicable FDA regulationsPerform 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 findingsAssess audit findings, determine risk levels, and drive effective corrective and preventive actions (CAPA)Maintain all audit, vendor, and compliance documentation within the QMSSupport and enhance the internal compliance program and audit processesTrack, analyze, and report audit metrics to QA leadershipPartner cross-functionally to ensure alignment on quality and compliance expectationsSupport regulatory inspection readiness and internal training initiativesTravel to supplier sites (domestic and occasional international) for auditsQualificationsBachelor's degree (BS/BA) in a scientific or technical field5+ years of QA auditing experience in a cGMP-regulated environment5+ years of external supplier/vendor auditing experience within an FDA-regulated industryStrong knowledge of 21 CFR Parts 210, 211, 507, and 111 (dietary supplements)Hands-on experience with both internal and external auditsExperience managing supplier quality programs, vendor qualification, and audit documentationFamiliarity with QMS systems (Qualityze preferred) and SAPProficient in Microsoft OfficePreferred QualificationsASQ Certified Quality Auditor (CQA) certificationExperience auditing CMOs and contract laboratoriesAdditional RequirementsAbility to travel 20-30% for domestic supplier audits (with occasional international travel)Ability to work in manufacturing and cleanroom environments, including use of required PPEStrong communication skills and ability to work across all levels of the organizationWhy Join Us?High-impact role supporting a growing QA functionStrong leadership and collaborative team environmentCompetitive compensation + bonus potentialComprehensive relocation supportINDBH#LI-ES1We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.