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 standardsSupportrecord reviewand quality documentation (including batch records and associated reports)Manage/supportchange control, deviations,



CAPAand investigationsWork with internal stakeholders to maintain compliance with relevant regulatory expectations (e.g.TGA / FDA / EMA)Contribute toprocess development and validationactivities for new and existing productsProvide quality input into planning discussions and continuous improvement initiativesEnsure compliance withradiation safetyrequirements and company policies
About you (essential)
Tertiary qualification inChemistry, Engineering, Pharmaceutical Sciencesor a related discipline5+ years' experiencein quality management within regulated manufacturing (GMP/cGMP)Strong knowledge ofcGMPand regulator expectations (TGA/FDA/EMA)Solid documentation skills; confident with Microsoft Office and QMS-related systemsAbility to work to timelines in a fast-paced environmentExcellent communication and problem-solving skills; confident collaborating across teams
Desirable
Experience incGMP radiopharmaceutical manufacturingFamiliarity withPIC/S / ICHguidelines
#J-*****-Ljbffr

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