Manufacturing Compliance Officer

5 days ago

Sydney, New South Wales, Australia Australian Biotechnologies Full time $60,000 - $80,000 per year

Manufacturing Compliance Officer

We are Australia's leading manufacturer of allograft implants (Bioimplants), committed to advancing healthcare through innovative solutions. As we continue to expand, we're seeking a diligent and experienced individual to join our team in the role of Manufacturing Compliance Officer

Reporting directly to the Postproduction & Compliance Manager, the successful candidate will play a pivotal role in ensuring the seamless post-production processes and adherence to regulatory standards. You will be joining a new expanding team within the company so there is opportunity for progression for the right candidate.

Key Responsibilities:

  • Assist in the dispatch, receipt, and quality control checking of allografts from external terminal irradiation facilities.
  • Coordinate the scheduling and dispatch of product samples for release and QC testing.
  • Prepare processing chemicals in an aseptic environment for allograft production.
  • Support the post-production team in final packaging, freeze drying, and SCF Sterilisation.
  • Conduct quality control checks at all post-production stages to ensure compliance with internal and regulatory standards.
  • Manage non-conforming tissue quarantine and facilitate timely completion of deviations/non-conformances.
  • Ensure accurate documentation completion as per Australian Biotechnologies Standard Operating Procedures.
  • Maintain and manage allograft processing database and excel spreadsheets.
  • Collate processing records and testing results for review by the Post Production & Compliance Manager.
  • Provide administrative support to the Post Production & Compliance Manager.
  • Collaborate effectively with internal stakeholders including QA/QC, Production, and Innovation and Engineering teams.
  • Conduct data analysis and assist in monthly reporting on KPIs and process turnaround times.
  • Stay updated on new technologies in tissue banking and graft manufacturing through external and internal training.

Qualifications and Skills:

  • Experience in pharmaceutical/healthcare/life sciences sectors.
  • Previous experience in quality control and/or compliance.
  • Strong ethical standards and understanding of the sensitive nature of the work.
  • Demonstrated ability to work independently and access information required for manufacturing human tissue grafts.
  • Excellent verbal and written communication skills.
  • Basic understanding of microbiological principles and aseptic technique.
  • Efficient time management and organizational skills.
  • Attention to detail and accuracy.

Application Process: Interested candidates should submit a cover letter expressing their understanding of human anatomy, human tissue allograft manufacturing, and/or clean room environments, along with their resume. Only shortlisted candidates will be contacted for an interview.

Additional Information: Free allocated car spot available on site, also conveniently located close to a bus stop. Working hours 8am-4pm Monday-Friday, however hours can be discussed.

For more information about our company, please visit 

To learn more about the industry, we recommend reading the article provided by ABC News: 

Note: Due to the high volume of applications, only shortlisted candidates will be contacted.

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