Quality Assurance Specialist

3 days ago


Auckland, Auckland, New Zealand Australian Nuclear Science & Technology Organisation Full time

About the Opportunity

The Quality Assurance Specialist plays a critical role in maintaining the operational elements of the Quality Management System (QMS) to ensure compliance with regulatory requirements. This includes TGA licenses, PIC/s Code of GMP for Medicinal Products, ISO 9001, TGA, FDA, and ARPANSA standards.

As a key member of the team, the specialist will work closely with production and engineering teams to ensure the highest quality nuclear medicine is manufactured. This involves embedding quality processes into all facets of manufacture through the quality on the floor program.

Your Duties and Responsibilities

  • Driving transformational quality culture initiatives across the site by liaising with cross-functional teams.
  • Providing Quality leadership to cross-functional teams working on FMEA, root cause analysis, and other investigative tools.
  • Providing specialist advice to staff and management on issues related to ANSTO Nuclear Medicine Product quality.
  • Serving as the key point of contact for product quality queries and investigations.
  • Leading and acting as the key product quality SME during regulatory inspections.

About You

We are seeking a highly motivated and passionate Quality Assurance professional with a drive to achieve cultural transformation.

- Sherry Lee, Operational Quality Assurance Manager



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