Product Quality Associate

Position Overview

• Ongoing| Full Time | $97k - $109k +15.4% super | Salary sacrificing available
• 2 positions available  |  Sutherland Shire location I Flexible Work practices I Health & Wellbeing Programs
• On-site Childcare for employees | Bus from Sutherland Station | free parking onsite
• An opportunity to apply your Quality Assurance expertise in a niche pharmaceutical environment

About the Opportunity

The Product Quality Associate maintains 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 in accordance with all regulatory guidelines.

About You

"We are seeking a highly motivated and passionate Quality Assurance professional with a drive to achieve cultural transformation"  Lee-Ann Carrasco, Head of Quality

Your Duties and Responsibilities

• Manage overall authorisation of release for supply and second stage release of finished goods and API.
• Support Quality systems inclusive of management of change (MOC), corrective actions and preventative actions (CAPA), audits, document management, deviations, supplier management, out of specification-tolerance (OOS-OOT), Product Quality Review (PQR), customer complaints, and sterility assurance.
• Ensure product quality and site compliance systems are aligned with current GMP standards, site licencing and market authorisation, periodically reviewed / updated, communicated and trained to all relevant staff.
• 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 click here to view the Position Description.

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.
 

Working with us you will enjoy:

ANSTO offers training and development, performance base salary increases and an extensive range of leave provisions to help employees balance work and personal commitments.

• 18 days personal/carers leave for each year of service
• 3 days paid leave between Christmas and New Year
• Generous parental leave provisions:
  • 18 weeks Parental leave for primary caregiver
  • 8 weeks Parental leave for secondary caregiver (with incremental increase to a maximum of 18 weeks effective 01/03/2027)

• Annual flu vaccinations
• Cultural, Naidoc and First Nations ceremonial leave

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.  For all other queries please contact Talent Acquisition on 9717 9361

To be eligible for appointment, applicants will require a security and pre-employment medical assessment.

Application closing date:  11:59pm 27 May 2025

Australian citizens preferred.

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.