Product Quality Associate

Position Overview Fixed Term 1 Year I Full Time | $89k - $101k +15.4% super | Salary sacrificing available Sutherland Shire location I Flexible Work practices I Health & Wellbeing Programs On-site Childcare for employees | Work in a campus-based community environment An opportunity to apply your Quality Assurance expertise in a niche pharmaceutical environment About the Opportunity The primary objective of the Product Quality Associate is to maintain the operational elements of the Quality Management System (QMS) in accordance with the TGA licenses to manufacture therapeutic goods, the PIC/s Code of GMP for Medicinal Products parts 1 and 2 and the associated annexes, ISO 9001, TGA, FDA, ARPANSA regulatory requirements. This role will work closely with operational teams from production and engineering to ensure ANSTO continues to manufacture nuclear medicine of the highest quality.About You "We are seeking a highly motivated and passionate Quality Assurance professional with a drive to achieve cultural transformation." - Amanda Lawson, Operational Quality Assurance ManagerYour Duties and Responsibilities 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. Provide specialist advice to staff and management. SME on issues related to ANSTO Nuclear Medicine Product quality. Key point of contact for product quality queries and investigations. Provide leadership and act as the key product quality SME during regulatory inspections. Through active engagement with the divisional Quality team and external stakeholder groups, define GxP practices and standards for the site and lead gap assessments and improvement projects as required for product(s). Please to view the Position Description or click Apply to view.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. Benefits of Working with Us ANSTO employees are passionate about what they do. We enjoy being part of an organisation making a difference in the lives of Australians. We support and reward our employees through eligibility for: Training, development and mentoring opportunities Performance based salary increases Work-life balance with generous leave entitlements and flexible conditions If you want to join a world class organisation that's making a difference in the lives of Australians, apply now!How to Apply For further technical information relating to this position please refer to the Position Description or contact Amanda Lawson on (02) 9717 9980. For all other queries please contact Talent Acquisition on +61 (02) 9717 9361. To be eligible for appointment, applicants will require a security and pre-employment medical assessment. Application closing date: 11:59PM Sunday 28th April 2024 All applicants must be Australian citizens. In order to solve great challenges, we need great minds and great teams. At ANSTO, we understand that diverse teams produce better outcomes and we value the merit that a diverse perspective can bring to our team. We encourage people from diverse backgrounds to apply for our roles including Aboriginal and Torres Strait Islander people, primary carers, those with a disability, and women in STEM. ANSTO is a charter member of the Science in Australia Gender Equity (SAGE) initiative and is proudly taking action to create a gender-inclusive workforce.