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 environment. 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 QMSin line withcGMPand internal standards
Supportrecord reviewand quality documentation (including batch records and associated reports)
Manage/supportchange control, deviations, CAPAand investigations
Work with internal stakeholders to maintain compliance with relevant regulatory expectations (e.g.TGA / FDA / EMA)




Contribute toprocess development and validationactivities for new and existing products
Provide quality input into planning discussions and continuous improvement initiatives
Ensure compliance withradiation safetyrequirements and company policies

About you (essential)
Tertiary qualification inChemistry, Engineering, Pharmaceutical Sciencesor a related discipline
5+ years’ experiencein quality management within regulated manufacturing (GMP/cGMP)
Robust knowledge ofcGMPand regulator expectations (TGA/FDA/EMA)
Strong documentation skills; confident with Microsoft Office and QMS-related systems
Ability to work to timelines in a quick-paced workplace
Excellent communication and problem-solving skills; confident collaborating across teams

Desirable
Experience incGMP radiopharmaceutical manufacturing
Familiarity withPIC/S / ICHguidelines
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📌 Quality Assurance Associate Queensland (Australia)
🏢 Fuse Recruitment
📍 Australia