Quality Assurance Associate
Job Type: Full time
Acknowledgement of Country
CSIRO acknowledges the Traditional Owners of the land, sea and waters, of the area that we live and work on across Australia. We acknowledge their continuing connection to their culture and pay our respects to their Elders past and present. View our vision towards reconciliation
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.
- 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 partnership with the leadership team, QA Manager, and other subject matter experts to conduct risk assessments, batch documentation review for release, and evaluate and independently close out deviations encountered in operations.
- Applying sound Quality Risk Management principles and judgement in the investigation of underlying issues of complex nature that contribute to observed deviations and non-conformances encountered in manufacturing and testing operations. Work independently to bring such investigations to satisfactory conclusion with outcome to improve performance of the Quality System.
- 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
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 of MS Office applications is required for performance of core duties.
- Demonstrated experience in the application of Quality Risk Management principles in the investigation of manufacturing deviations with complex underlying causes. Demonstrated ability to make decisions based on risk and provide sound justification.
- Experience in the application of tools for investigating process deviations (such as fishbone analysis, human error analysis)
- 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.
Applications are open to Australian/New Zealand Citizens and Australian Permanent Residents Only. Appointment to this role is subject to provision of a national police check and may be subject to other security/medical/character requirements.
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.
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 future scientists in person or online. Source – CSIRO Child Safe policy 2023
Join us and start creating tomorrow today!
How to Apply
Please apply on-line and provide a cover letter and CV that best demonstrate your motivation and ability to meet the requirements of this role.
31 May 2023, 11:00pm AEST