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Astrix Inc

QA Auditor (FDA/GMP/21 CFR)

Lancaster, SC · On-site

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 ...

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$235K - $280K/yr

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Pittsburgh, PA

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Siemens Energy, Inc.

Assembler - Manufacturing

Charlotte, NC · On-site

$16 - $19.75/hr

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QA Auditor (FDA/GMP/21 CFR)

QA Auditor (FDA/GMP/21 CFR)

Astrix Inc

Lancaster, SC • On-site

Full-time

Posted 13 days ago

Job description

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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