GMP Biologics QC Analyst: Environment & Micro Testing

CSIRO; Melbourne; On-site; AUD 76,000 - 96,000; Full time

Benefits offered by this job

15.4% superannuation

12-month contract

Job summary

CSIRO is seeking a Quality Control Analyst for its GMP pilot-scale biologics facility in Australia. In this hands-on role, you will perform environmental monitoring and microbiological testing, review data trends, support investigations and contribute to biochemical and biophysical testing where qualified.

Working within a regulated laboratory, you will help maintain data integrity, regulatory readiness and continuous improvement while supporting Australian and international research 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 testing

Environmental monitoring

Data integrity

Regulatory readiness

qPCR

Documentation

Problem solving

Teamwork

Education

Bachelor’s degree or higher in microbiology or related field

Tools

Automated microbial detection systems

HPLC

CE-SDS

cIEF

ELISA

TOC

Endotoxin testing

Job description

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.

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.
• 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.

For full details about this role, and other criteria, please review the Position Description.

Not sure if you meet all the criteria?

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 that it may be helpful for us to adjust our process to make it equitable for your individual situation. Please contact Laura Mason via **************@csiro.au and let us know how we can support you.

Life at CSIRO and flexible work arrangements

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

Applications for this position are open to Australian/New Zealand Citizens, and 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.

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 CV and cover letter (maximum 2 pages) that demonstrate your motivation and ability to meet the selection criteria of this role.

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