POSITION OVERVIEW

• Ongoing | Full Time | $133k - $149k +15.4% super | salary sacrificing available
• Onsite Childcare for Employees | Cafe on site | generous leave provisions
• Sutherland Shire location I Health & Wellbeing Programs I bus from Sutherland Station
• Looking for a Quality Assurance & Compliance professional who has experience in end-to-end GMP manufacturing.

ABOUT YOU

We are looking for a highly motivated and passionate Quality Assurance and Compliance professional who has experience in end-to-end GMP manufacturing. The ideal candidate will have experience in management of quality systems, release for supply as an authorised person, a good understanding of facility control and sterility assurance.” - Lee-Ann Carrasco, Head of Quality

ABOUT US

ANSTO leverages great science to deliver big outcomes. We partner with scientists and engineers and apply new technologies to provide real-world benefits. Our work improves human health, saves lives, builds our industries and protects the environment. ANSTO is the home of Australia’s most significant landmark and national infrastructure for research. Thousands of scientists from industry and academia benefit from gaining access to state-of-the-art instruments every year.

• As a manager and product quality expert, lead and develop staff to ensure a depth of technical knowledge within Nuclear Medicine.
• Driving the transformational quality culture initiatives across the site by liaising with cross functional teams. Embed quality processes into all facets of manufacture through the quality on the floor program. Provide Quality leadership to cross-functional teams working on FMEA, root cause analysis, and other investigative tools to ensure a holistic and systemic quality approach is imbedded in everything we do.
• Conduct regular evaluation of quality product systems including analysis of changes in legislation, nuclear medicine policies, procedures, training, and communication.
• Manage overall release for supply and second stage release of starting material, intermediates, finished goods and API in accordance maintaining current regulations whilst meeting operational and customer requirements.
• Management of the investigation of operational component of non-conformances, including key participation in the identification and raising of issues, root cause analysis, identification, and implementation of corrective and preventative actions