A leading organisation in the radiopharmaceutical manufacturing space is seeking aQuality Assurance Associateto support the implementation, maintenance and continuous improvement of aQuality Management System (QMS)in acGMP-regulatedenvironment.
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 asvalidation and verification.
Key responsibilities
Maintain and support theQMSin 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 current 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)
Strong knowledge ofcGMPand regulator expectations (TGA/FDA/EMA)
Robust documentation skills; confident with Microsoft Office and QMS-related systems
Ability to work to timelines in a fast-paced setting
Excellent communication and problem-solving skills; confident collaborating across teams
Desirable
Experience incGMP radiopharmaceutical manufacturing
Familiarity withPIC/S / ICHguidelines
J-*-Ljbffr

📌 Quality Assurance Associate Queensland
🏢 Fuse Recruitment
📍 Queensland