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

**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).

**About Us**:
**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

**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._