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cGMP Quality Assurance Assistant

Date: 13-Jan-2022

Location: Melbourne, VIC, AU

Company: CSIRO

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.

The Opportunity

 

  • ​​​​​​Gain Quality Assurance experience in manufacturing products for preclinical and clinical (Phase I and II) studies!
  • Grow your QA career in our New cGMP Biologics Facility!
  • Join CSIRO - Australia's Premier Science and Technology Research Organisation

 

CSIRO’s Manufacturing Business Unit brings together multi-disciplinary scientific and engineering capabilities using world-class infrastructure to partner with industry in order to develop innovative products and processes to allow Australian manufacturers to be globally competitive and environmentally sustainable. Our Biomedical Manufacturing Research Program works with biomedical companies to deliver new medical treatments and technologies that benefit millions of people in Australia and overseas, helping them live longer, healthier, and more productive lives. 

 

Reporting to the Team Leader, GMP Manufacturing, the Quality Assurance (QA) Assistant supports GMP manufacture of vaccine and biotherapeutic proteins for use in preclinical and early human clinical (Phase I and II) studies and brings the knowledge of Quality Assurance frameworks for the development of new human biologic products.  This role is responsible for the overall quality approach in the manufacture of clinical materials as a step in the pathway towards eventual registration in regulated global markets. 

Your duties will include:

  • Accountable for writing sections of the Quality Manual to include GMP facility design and qualification; establishing of GMP training programs for staff, and maintaining documents that are essential in GMP operations.
  • Contributing to the Validation program for a newly constructed GMP facility, by authoring Validation protocols and reporting for equipment items, facilities, and newly developed manufacturing protocols. 
  • Under guidance scheduling and completing major sections of the Validation Master Plan. This will involve allocating and directing tasks to other CSIRO colleagues and contractors, where appropriate. 
  • Work with limited guidance in conducting risk assessments, batch review and release, and evaluate planned deviations and nonconformances encountered in GMP operations.
  • Designing new QA frameworks by adapting existing systems to meet new requirements in line with the GMP project portfolio. 

 

Location: Melbourne (Clayton), Victoria

Salary: AU$87k - AU$98k plus up to 15.4% superannuation

Tenure: Indefinite 

Reference: 80221

To be considered you will need:

  • A degree in science or business management with relevance to quality management.
  • Comprehensive experience in conducting QA activities to support GMP manufacture of biotechnology products.
  • Demonstrated experience in drafting Validation protocols and reports and associated quality documents.
  • Demonstrated experience in the application of scientific principles in the investigation of manufacturing deviations with complex underlying causes.
  • Demonstrated knowledge of QA frameworks for regulated manufacture of human health medicines, such as the Australian TGA, US FDA and EMA.
  • First-hand experience in preparing for and providing representation in external audits by regulatory bodies.

 

For full details about this role please review the Position Description

Eligibility

Applications for this position are open to Australian Citizens and Permanent residents residing in Australia only.

 

Appointment to this role is subject to the provision of a national police check and may be subject to other security/medical/character requirements.

Flexible Working Arrangements

We work flexibly at CSIRO, offering a range of options for how, when and where you work. 

Diversity and Inclusion

We are working hard to recruit people representing the diversity across our society, and ensure that all our people feel supported to do their best work and feel empowered to let their ideas flourish. 

About CSIRO

At CSIRO Australia's national science agency, we solve the greatest challenges through innovative science and technology. We put the safety and wellbeing of our people above all else and earn trust everywhere because we only deal in facts. We collaborate widely and generously and deliver solutions with real impact. 


Join us and start creating tomorrow today!

How to Apply

Please apply on-line and provide a cover letter and CV that best demonstrate your motivation and ability to meet the requirements of this role.

Applications Close

06 February 2022, 11:00pm AEDT