GMP Biologics QC Analyst - Environmental & Micro Testing

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

Job summary

CSIRO is recruiting for a Quality Control Analyst to support early-stage clinical trials in its GMP pilot-scale biologics facility. You will perform environmental monitoring and microbiological testing, review quality data, and aid investigations while contributing to biochemical and biophysical testing as qualified.

The role emphasizes maintaining data integrity, regulatory readiness, and continuous improvement within a collaborative, regulated laboratory environment across Australian and

Qualifications

• 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.
• Strong 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.

Responsibilities

• 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.

Skills

Microbiology degree

GMP lab experience

qPCR

Environmental monitoring

Data review

Problem solving

Multidisciplinary teamwork

Molecular QC methods

Biochemical QC techniques

PIC/S GMP knowledge

Biologics testing

Education

Bachelor’s degree or higher in microbiology/biomedical/biotech/biological sciences

Tools

HPLC

CE-SDS

cIEF

ELISA

TOC

Endotoxin testing

Job description

CSIRO is recruiting for a Quality Control Analyst to support early-stage clinical trials in its GMP pilot-scale biologics facility. You will perform environmental monitoring and microbiological testing, review quality data, and aid investigations while contributing to biochemical and biophysical testing as qualified.

The role emphasizes maintaining data integrity, regulatory readiness, and continuous improvement within a collaborative, regulated laboratory environment across Australian and