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Role highlights

- Support early-stage clinical trials through quality control testing in CSIRO’s GMP biologics facility.
- Perform environmental monitoring and microbiological testing in a hands-on, regulated laboratory.
- Drive data integrity, regulatory readiness and continuous improvement across quality operations.

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.

Join CSIRO’s GMP pilot-scale biologics facility as a Quality Control Analyst and help deliver high-quality products for early-stage clinical trials. In this hands-on role, you will perform environmental monitoring and microbiological testing, review and trend quality data, support investigations, and contribute to biochemical and biophysical testing where qualified. Working within a collaborative, regulated laboratory, you will help maintain data integrity, regulatory readiness and continuous improvement while supporting Australian and international research and biopharmaceutical organisations.

Your high-level duties will include:

- Perform GMP environmental monitoring in classified areas, including routine, qualification and investigational sampling.




- Conduct microbiological testing using conventional and rapid methods, including sample preparation, incubation, enumeration and reporting.
- Review and trend environmental monitoring data, escalating excursions, atypical results, adverse trends and potentially objectionable organisms.
- Where qualified, perform biochemical and biophysical testing of raw materials, in-process samples, drug substance and drug product.
- Manage samples, reagents, media, reference standards and controls while maintaining traceability, segregation and accurate records.
- Support method development, qualification and transfer, stability testing, outsourced testing and implementation of rapid microbiological methods.
- Maintain GMP, quality and data-integrity compliance, including investigations, CAPA, change controls, risk assessments, audits and controlled documentation.
- Operate and maintain laboratory equipment, support qualification and validation activities, and collaborate with QA, Production and other stakeholders to uphold safety and continuous improvement.

Salary: AU$76k - AU$96k per annum + 15.4% superannuation

Tenure & work schedule: Specified term of 12 months, Full-time

Reference: 104326

As the successful candidate, you will bring:

- Bachelor’s degree or higher in microbiology, biomedical science,



biotechnology, biological science or a related discipline, or equivalent relevant experience.
- Practical experience in microbiological testing and environmental monitoring of cleanrooms or controlled environments within a GMP-regulated pharmaceutical or comparable laboratory.
- Ability to assess and investigate environmental-monitoring excursions, deviations and OOS/OOT events, and to prepare accurate GMP-compliant documentation.
- Solid problem-solving, communication and multidisciplinary teamwork skills.
- Hands on experience with molecular QC analytical methods, particularly qPCR, including sample preparation, assay execution, data analysis and basic troubleshooting.
- Experience with conventional and rapid microbiological methods, including automated microbial detection systems, microbiological data review and environmental-monitoring trending.
- Experience with additional biochemical or biophysical QC techniques, such as HPLC, CE-SDS, cIEF, ELISA, TOC, endotoxin or spectrophotometric methods.
- Knowledge of TGA PIC/S GMP and applicable pharmacopoeial microbiology requirements.
- Experience in biologics, recombinant proteins or monoclonal antibody testing.

While it is CSIRO policy that the successful candidate must meet all the essential criteria, there are many ways to demonstrate this. Don’t let the list discourage you. If you are unsure about applying, please reach out to the contact person in the Position Description.

Setting you up for success

We are committed to providing a recruitment process that is fair, equitable and accessible to everyone. We recognise

📌 GMP Biologics QC Analyst (Melbourne)
🏢 Commonwealth Scientific And Industrial Research Organisation
📍 Melbourne