Quality Assurance Compliance Specialist

2 days ago

Charlotte Bay, Australia beBeeAuditor Full time $70,000 - $90,000

Are you a detail-oriented professional looking to play a key role in maintaining compliance across internal operations and external suppliers? We are seeking a Quality Assurance Auditor to join our team.


This individual will be responsible for developing and executing a strong audit and compliance program. The successful candidate will have the opportunity to influence quality culture across both internal operations and supplier networks, work closely with leadership on compliance strategy, and gain visibility through direct involvement with audits and regulatory readiness.


Key Responsibilities:
  • Plan, schedule, and execute internal and external audits.
  • Conduct supplier/CMO audits, manage vendor qualification, and maintain the Approved Vendor List.
  • Oversee the supplier corrective action request program (SCAR) and track audit findings through resolution.
  • Manage audit-related documentation within the Quality Management System (QMS).
  • Support and train internal departments to ensure compliance with FDA and company requirements.
  • Assist in regulatory inspection readiness and provide audit support to QA leadership.
  • Collaborate with CMOs on investigations, CAPAs, and product development support.
  • Provide regular audit performance metrics and compliance reporting to leadership.
  • Travel domestically 20-30% (international travel may be required as needed).

Qualifications:
  • Bachelor's degree in Science or Technical discipline required.
  • Five or more years of Quality Assurance auditing experience in a cGMP environment.
  • Five or more years of external vendor/supplier auditing experience within an FDA-regulated industry.
  • Strong working knowledge of 21 CFR Parts 210, 211, 507, and 111 (Dietary Supplements).
  • ASQ Certified Auditor (CQA) certification strongly preferred.
  • Proficiency in MS Office and experience with QMS software (SAP, Qualityze, or equivalent).
  • Ability to work in a variety of environments, including manufacturing and clean rooms, and wear all required PPE.

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