GMP Quality Control Analyst – Biologics & Microbiology

Commonwealth Scientific and Industrial Research Organisation; Melbourne; On-site; AUD 76,000 - 96,000; Full time

Job summary

CSIRO invites applications for a Quality Control Analyst to support early-stage clinical trials in our GMP pilot-scale biologics facility. You will perform environmental monitoring and microbiological testing, review quality data, and contribute to biochemical and biophysical testing where qualified, ensuring data integrity and regulatory readiness.

This hands-on role emphasizes collaboration within a regulated lab to deliver high-quality products for Australian and international research

Qualifications

• Bachelor’s degree or higher in microbiology, biomedical science, biotechnology, biological science or a related discipline, or equivalent relevant experience.
• Hands-on experience with molecular QC analytical methods, particularly qPCR, including sample prep, assay execution, data analysis and troubleshooting.
• Experience with conventional and rapid microbiological methods, including automated detection systems and environmental-monitoring trending.

Responsibilities

• Perform GMP environmental monitoring in classified areas, including routine, qualification and sampling.
• Conduct microbiological testing using conventional and rapid methods, including sample preparation, incubation, enumeration and reporting.
• Review and trend environmental monitoring data, escalating excursions and adverse trends.

Skills

Problem solving

Communication

Teamwork

Education

Bachelor’s degree in microbiology or related field

Tools

qPCR

HPLC

CE-SDS

cIEF

ELISA

TOC

Job description

CSIRO invites applications for a Quality Control Analyst to support early-stage clinical trials in our GMP pilot-scale biologics facility. You will perform environmental monitoring and microbiological testing, review quality data, and contribute to biochemical and biophysical testing where qualified, ensuring data integrity and regulatory readiness.

This hands-on role emphasizes collaboration within a regulated lab to deliver high-quality products for Australian and international research