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cGMP Quality Assurance Assistant

Date: 22-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

 

  • ​​​​​​Quality Assurance in preclinical (Phase 1) 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 1) 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:

  • Participating in all aspects of conceptualisation and implementation of a Quality system to support GMP and related ISO and GMP-like activities. 
  • Writing sections of the Quality Manual to include GMP facility design and qualification, the establishment of GMP training programs for staff, and the generation and maintenance of documents that are essential in GMP operations.
  • Designing, implementing, and maintaining an electronic Quality Management System (eQMS) that supports core GMP activities like documentation control, establishment and management of controlled changes within GMP operations, and the establishment and tracking of corrective action plans as part of continuous improvement. 
  • Ensuring the inspection readiness by both customers, external auditors, and officers of national and global regulatory bodies and managing post-inspection corrective action plans.
  • Under guidance, designing new QA frameworks by adapting existing systems to meet new requirements in comparison to GMP programs across multiple laboratories encompassing both manufacturing and testing activities.
  • Conducting risk assessments, batch review and release, and evaluating planned deviations and nonconformances encountered in GMP operations.
  • Working in a guided manner to engage with clients as an authority on matters related to the QA function in the CSIRO GMP program.
  •  Acting as a trusted advisor and compliance champion, utilising knowledge of clients’ business and understanding of their underlying needs.

 

Location: Melbourne, Clayton, Victoria

Salary: AU$66k - AU$84k plus up to 15.4% superannuation

Tenure: Indefinite 

Reference: 80210

To be considered you will need:

  • A degree in science or business management with relevant experience in quality management.
  • Demonstrated experience in conducting QA activities to support GMP manufacture of biotechnology products.
  • Direct knowledge and hands-on practical experience in the principles of quality management as defined by AS/NZS ISO 9001 2015.
  • Demonstrated experience in preparing for and ability to face external audits by regulatory bodies
  • Strong written and oral communication skills including the ability to articulate clearly with the auditor and set expectations and solutions in relation to our quality framework.

 

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