Job Description

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

Role highlights

• Drive Quality Assurance (QA) across biomanufacturing, and deliver scientific and technical support for GMP manufacturing, quality control and biomedical materials development
• Strengthen regulatory compliance through regulator engagement and ensure facilities meet TGA and GMP standards
• Champion continuous improvement by analysing quality data and enhancing QA processes

About CSIRO

As Australia's national science agency, CSIRO is solving the greatest challenges through innovative science and technology. Many of our iconic innovations were once considered impossible until someone, just like you, joined us and took on the challenge.

Visit CSIRO.au for more information.

The opportunity

We have a dynamic and inclusive team within the Quality Assurance Team and are seeking applicants for the role of Quality Associate.

The purpose of this position as part of the Quality Assurance team is to provide hands-on support for quality assurance aspects of manufacturing, quality control operations of vaccines, recombinant proteins and biomedical materials translation. The position reports to the Team Leader - Quality Assurance and is responsible for providing advanced manufacturing and scientific knowledge to support the development and implementation of quality systems. This is to ensure compliance with GMP standards and TGA regulatory requirements for early-phase clinical manufacturing and biomedical material development.

The role plays a key function in ensuring quality assurance oversight in the execution of manufacturing and quality control protocols within the Regulated Biomanufacturing facilities. The successful candidate will be a team player with highly developed written and verbal communication skills.

Your high-level duties will include:

• Provide advanced scientific support in all aspects of quality assurance aspects of manufacturing and quality control operations, for the development of therapeutics in a regulated manufacturing (GMP) environment and the development of biomedical materials in regulated clean room environments.
• Support the engagement activities with various regulators to ensure all CSIRO Regulated Biomanufacturing (CRB) facilities are compliant under relevant compliance frameworks.
• Support the quality management system and analyse data to identify opportunities for continuous improvement in Quality Assurance (QA) systems to reduce quality issues and process inefficiencies.
• Support the oversight of all QA systems to ensure regulatory compliance for facilities under CRB and at a ready state for regulatory inspections.

Role particulars & eligibility

• Location: Melbourne (Clayton site)
• Salary: AU$100,103 - AU$113,251 per annum (pro rata for part-time), plus 15.4% superannuation
• Tenure & work schedule: Indefinite; Full-time (Options for part-time, job-share and flexible work arrangements can be discussed based on needs of role and individual circumstances)
• Reference: 102650

Eligibility

• Applications for this position are open to Australian Citizens, New Zealand Citizens, Australian Permanent Residents.
• Appointment to this role is subject to provision of a national police check and may be subject to other security/medical/character requirements. Please refer to the Position Description for details.

As the successful candidate, you will bring:

• A degree in Microbiology, Biotechnology, Biochemical Engineering or related field or equivalent experience.
• Industry experience in GMP quality assurance within pharmaceutical or biopharmaceutical manufacturing, preferably in clinical trial material production.
• Knowledge of TGA regulatory requirements and international harmonised GMP standards (e.g., PIC/S, ICH etc).
• Direct experience and working knowledge of current GMP frameworks for the manufacture of human vaccines and biotherapeutics with global regulators such as the US Food and Drug Administration, and/or European Medicines Authority.
• Experience in influencing third parties through communication to gain support for potentially contentious proposals.
• Demonstrated ability to proactively identify and mitigate risks, supported by a consistent compliance focus and high attention to detail.

For full details about this role, and all criteria, please review the Please note: Under CSIRO policy only those who meet all essential criteria can be appointed.

Setting you up for success

We are committed to providing a recruitment process that is fair, equitable and accessible to everyone. We recognise that individuals may have different needs, and we’re happy to discuss what adjustments to our process may help you feel safe, respected and able to participate fully. Please contact careers.online@csiro.au and let us know how we can support you.

Life, benefits and flexible work arrangements

We work flexibly at CSIRO, offering a range of options for how, when and where you work. We can discuss flexible work arrangements with you during the recruitment process. CSIRO also offers a range of leave entitlements, benefits and career development opportunities. To find out more, visit Careers at CSIRO

Inclusion and belonging

Solving Australia's greatest challenges takes a diversity of minds and lived experiences. We know diverse teams are more effective and deliver more innovative outcomes. As an equal employment opportunity organisation, we are committed to creating diverse and inclusive teams where people feel they belong. We recognise true diversity encompasses all ages, abilities, cultures, faiths, levels of education, genders, sexualities, diversity of thought and much more. We focus on hiring people who share our values of People First, Further Together, Making it Real and Trusted.

CSIRO holds Platinum Status for the Australian Workplace Equality Index for LGBTQIA+ inclusion, and a Science in Australia Gender Equity Bronze Award.

Child safety

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

How to apply

Please apply online and submit a cover letter (maximum 2 pages) and CV that demonstrate your motivation and ability to meet the essential requirements of this role.

Applications close

17 March 2025, 11:00pm AEDT