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QA Auditor (FDA/GMP/21 CFR)Astrix Inc • United States
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QA Auditor (FDA/GMP/21 CFR)

Astrix Inc
  • US
    United States
  • US
    United States
Postuler Maintenant

À propos

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 INDBH #LI-ES1
  • United States

Compétences linguistiques

  • English
Avis aux utilisateurs

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