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 with cGMP and internal standards Support record review and quality documentation (including batch records and associated reports) Manage/support change control, deviations, CAPA and investigations Work with internal stakeholders to maintain compliance with relevant regulatory expectations (e.g. TGA / FDA / EMA )



Contribute to process development and validation activities for new and existing products Provide quality input into planning discussions and continuous improvement initiatives Ensure compliance with radiation safety requirements and company policies

About you (essential) Tertiary qualification in Chemistry, Engineering, Pharmaceutical Sciences or a related discipline 5+ years’ experience in quality management within regulated manufacturing (GMP/cGMP) Strong knowledge of cGMP 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 in cGMP radiopharmaceutical manufacturing Familiarity with PIC/S / ICH guidelines

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