Overview
QA Auditor (FDA/GMP/21 CFR) Jobs in Lancaster, SC at Astrix
Title: QA Auditor (FDA/GMP/21 CFR)
Company: Astrix
Location: Lancaster, SC
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
- Competitive compensation + bonus potential
- Comprehensive relocation support
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