Manufacturing Compliance Officer

4 days ago

Frenchs Forest, Australia Australian Biotechnologies Pty Ltd Full time

_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_

**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 Manufacturing Compliance & Sterilisation Manager.
- Provide administrative support to the Manufacturing Compliance & Sterilisation 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.

**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.

Pay: From $70,000.00 per year

**Benefits**:

- Employee discount
- Professional development assistance

Schedule:

- 8 hour shift

Work Authorisation:

- Australia (required)

Work Location: In person

Application Deadline: 06/06/2025
Expected Start Date: 15/05/2025

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