Product Quality Associate

6 days ago

Lucas Heights, Australia ANSTO Full time

**Position Overview**:

- Ongoing| Full Time | $93k - $105k +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

**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.

**About You**:

- "We are seeking a highly motivated and passionate Quality Assurance professional with a drive to achieve cultural transformation." - _**_Sherry Lee, Operational Quality Assurance Manager_**

**Your 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).

**About Us**:
**Working with us you will enjoy**:
ANSTO offers 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: 2 March 2025 at 11:59pm**

**_All applicants must be Australian citizens._

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