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

Astrix Technology
  • US
    United States
  • US
    United States
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QA Auditor (FDA/GMP/21 CFR)
Quality Assurance
Lancaster , South Carolina, US
Added - 18/05/2026
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
We 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.
  • United States

Sprachkenntnisse

  • English
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