Product Quality Associate - Lucas Heights, Australia - ANSTO

ANSTO

Verified Company

Lucas Heights, Australia

2 weeks ago

Posted by:

Olivia Brown

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Description

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
Onsite Childcare for employees | Work in a campusbased community 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 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 crossfunctional 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:

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
Worklife balance with generous leave entitlements and flexible conditions

How to Apply:

For further technical information relating to this position please refer to the Position Description or contact Amanda Lawson on For all other queries please contact Talent Acquisition on

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._