Quality Control Analyst

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 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. Visit CSIRO.au for more information. The opportunity   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. Role particulars Location: Clayton, Melbourne VIC Salary: AU$76k - AU$96k per annum + 15.4% superannuation Tenure & work schedule: Specified term of 12 months,…