Senior Quality Operations Specialist

2 weeks ago

Sydney, New South Wales, Australia beBeeAssurance Full time $91,200 - $115,300

Job Title: Quality Assurance Specialist

We are seeking a highly skilled Quality Assurance Specialist to join our team based out of Marsden Park, NSW facility. As the Quality Assurance Specialist, you will play a critical role in ensuring the integrity and compliance of healthcare operations.

About the Role:

This position provides day-to-day quality support across warehouse and operational functions, ensuring adherence to client-specific requirements, regulatory standards, and internal procedures. Key responsibilities include:

  1. Quality Oversight & Compliance: Ensuring all warehouse and operational activities comply with internal procedures, client requirements, and applicable regulatory standards.
  2. Issue Management & Resolution: Timely investigation, documentation, and resolution of Non-Conformance Reports (NCRs), Corrective and Preventive Actions (CAPAs), and Change Controls.
  3. Customer & Stakeholder Engagement: Providing clear and professional communication with customers regarding Quality matters.
  4. Process & System Integrity: Oversight of SAS release, controlled destruction, and return to vendor sessions.
  5. Training & Documentation: Ensuring training records and labelling processes are compliant and current.
  6. Performance Monitoring: Tracking and trending Quality KPIs and metrics.

About You:

To be successful in this role, you will need:

  1. Solid knowledge of ISO 13485, with practical experience applying its principles in a healthcare, medical device, or pharmaceutical environment.
  2. Solid understanding of TGA regulations, PIC/S Code of GMP (Good Manufacturing Practices), and GWP (Good Warehouse Practices).
  3. Familiarity with ISO 9001 and its integration with ISO 13485 for quality management systems.
  4. Basic understanding of Supply Chain Management and Integrated Logistics.
  5. FMCG, Medical Devices, Food Manufacturing, Pharmaceuticals industry experience highly advantageous.
  6. Prior experience working in or with a logistics site is also advantageous.

About Toll Group:

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