Quality Assurance Associate

**Acknowledgement of Country**:
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CSIRO is committed to the safety and wellbeing of all children and young people involved in our activities and programs. View our Child Safe Policy.

**The Opportunity**:

- **Exciting Quality Assurance opportunity in Manufacturing**:

- **Support the overall Quality approach in manufacture of clinical materials**:

- **Join Australia’s National Science and Innovation Agency**

At CSIRO’s Manufacturing, we are industry’s innovation partner, working together to transform and build sovereign capability by developing new processes, materials and products.

We have an exciting opportunity for an experienced Quality Assurance (QA) Associate. Reporting to the Quality Operations Team Leader, the QA Associate provides expert services in the field of Quality Assurance (QA) to support manufacture of vaccine and biotherapeutic biologics for use in preclinical and early human clinical (Phase I and II) studies.

Your key function will be to maintain the Quality System and support the overall Quality approach in manufacture of clinical materials as a step in the pathway towards eventual registration in regulated global markets.

**Your duties will include**:

- Providing active support to all aspects of the Quality Management System, including the conceptualisation and implementation of a Quality framework.
- Participating in the design of QA frameworks by adapting existing systems to meet new requirements as commensurate with growth of the group project portfolio.
- Participating in activities for maintenance of an electronic Quality Management System (eQMS), and implementation of new modules, that supports core activities such as documentation control, establishment and management of controlled changes within operations, and the establishment and tracking of corrective action plans as part of continuous improvement.
- Serving as a point of accountability for inspections conducted by both customers and officers representing national and global regulatory agencies. Provide support to the regulated biomanufacturing function by leading activities in the realm of inspection readiness and management of post-inspection corrective action plans.
- Working in a guided manner to engage with clients as an authority on matters related to the QA function in the CSIRO regulated biomanufacturing program. Act as a trusted advisor and compliance champion, utilising knowledge of client’s business and understanding of their underlying needs.

**Location**: Clayton, VIC

**Salary**: AU$89,680 to AU$101,459pa (pro-rata for part-time) + up to 15.4% superannuation

**Tenure**: Indefinite, full time

**Reference**: 92889

**To be considered you will need**:

- Under CSIRO policy only those who meet all essential criteria can be appointed._
- A bachelor’s degree in science or equivalent with relevance to quality management.
- Comprehensive experience in conducting QA activities to support manufacture of biotechnology products with a minimum of two (2) years’ experience.
- Good organisation and decision making skills with high level of attention to details.
- Ability to work independently and as part of a team.
- Sound knowledge and practical experience in the operation of a Quality Management System/Pharmaceutical Quality System i.e. AS/NZS ISO 9001:2015 or equivalent.
- Sound knowledge and practical experience of QA frameworks for regulated manufacture of human health medicines, such as the Australian TGA, APVMA, US FDA and EMA.
- First-hand experience in preparing for and/or providing representation in external audits by regulatory bodies.

For full details about the role please view the Position Description.

**Eligibility**:
**Flexible Working Arrangements**:
We work flexibly at CSIRO, offering a range of options for how, when and where you work.

**Diversity and Inclusion**:
We are working hard to recruit people representing the diversity across our society, and ensure that all our people feel supported to do their best work and feel empowered to let their ideas flourish.

**About CSIRO**:
At CSIRO Australia's national science agency, we solve the greatest challenges through innovative science and technology. We put the safety and wellbeing of our people above all else and earn trust everywhere because we only deal in facts. We collaborate widely and generously and deliver solutions with real impact.

CSIRO is committed to values-based leadership to inspire performance and unlock the potential of our people.

CSIRO is committed to the safety and wellbeing of all children and young people involved in our activities and programs, whether we are undertaking research, engaging with the public or nurturing