Auditor Roles

1 day ago

Charlotte Bay, Australia beBeeAudit Full time $100,000 - $150,000
Quality Assurance Specialist

This position is a key component in our overall quality strategy, responsible for ensuring compliance with regulatory requirements and maintaining the highest standards of quality across internal operations and external suppliers.

The ideal candidate will possess strong analytical skills, attention to detail, and excellent communication abilities. They will work closely with cross-functional teams to develop and implement effective audit programs, conduct supplier audits, and manage vendor qualification processes.

  • Lead the planning, scheduling, and execution of 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).
Requirements
  • Bachelor's degree in Science or Technical discipline required.
  • 5+ years of Quality Assurance auditing experience in a cGMP environment.
  • 5+ 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) 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.
Why This Role Matters

This position plays a critical role in maintaining our reputation for excellence and ensuring the delivery of high-quality products to our customers.

The ideal candidate will have a passion for quality, a drive to improve processes, and a commitment to delivering exceptional results.

We offer a competitive compensation package, opportunities for professional growth and development, and a dynamic work environment that values teamwork and collaboration.

If you are a motivated Quality Assurance specialist with a passion for driving improvement and excellence, we encourage you to apply for this exciting opportunity.

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