A leading organisation in the radiopharmaceutical manufacturing space is seeking a Quality Assurance Associate to support the implementation, maintenance and continuous improvement of a Quality Management System (QMS) in a cGMP-regulated workplace. This role will suit a hands-on QA professional who enjoys working closely with operations and documentation to ensure compliance, quality and safety standards are consistently met.

The role

You’ll partner with cross-functional teams to support quality and regulatory compliance across the product lifecycle, including support for equipment transition and facility activities such as validation and verification .

Key responsibilities

- Maintain and support the QMS in line withcGMP and internal standards
- Supportrecord review and quality documentation (including batch records and associated reports)
- Manage/supportchange control, deviations, CAPA and investigations
- Work with internal stakeholders to maintain compliance with relevant regulatory expectations (e.g.TGA / FDA / EMA )




- Contribute toprocess development and validation activities for new and existing products
- Provide quality input into planning discussions and continuous improvement initiatives
- Ensure compliance withradiation safety requirements and company policies

About you (essential)

- Tertiary qualification inChemistry, Engineering, Pharmaceutical Sciences or a related discipline
- 5+ years’ experience in quality management within regulated manufacturing (GMP/cGMP)
- Strong knowledge ofcGMP and regulator expectations (TGA/FDA/EMA)
- Strong documentation skills; confident with Microsoft Office and QMS-related systems
- Ability to work to timelines in a fast-paced environment
- Excellent communication and problem-solving skills; confident collaborating across teams

Desirable

- Experience incGMP radiopharmaceutical manufacturing
- Familiarity withPIC/S / ICH guidelines

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📌 Quality Assurance Associate (Brisbane City)
🏢 Fuse Recruitment
📍 Brisbane City