Job Description
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.
n
The role
n
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.
n
Key responsibilities
n
n
Maintain and support the QMSin line withcGMPand internal standards
n
Supportrecord reviewand quality documentation (including batch records and associated reports)
n
Manage/supportchange
control, deviations, CAPAand investigations
n
Work with internal stakeholders to maintain compliance with relevant regulatory expectations (e.g.TGA / FDA / EMA)
n




Contribute toprocess development and
validationactivities
for new and existing products
n
Provide quality input into planning discussions and continuous improvement initiatives
n
Ensure compliance withradiation safetyrequirements and company policies
n
n
About you (essential)
n
n
Tertiary qualification inChemistry, Engineering, Pharmaceutical Sciencesor a related discipline
n
5+ years' experiencein quality management within regulated manufacturing (GMP/cGMP)
n
Strong knowledge ofcGMPand regulator expectations (TGA/FDA/EMA)
n
Strong documentation skills; confident with Microsoft Office and QMS-related systems
n
Ability to work to timelines in a fast-paced environment
n
Excellent communication and problem-solving skills; confident collaborating across teams
n
n
Desirable
n
n
Experience incGMP
radiopharmaceutical
manufacturing
n
Familiarity withPIC/S / ICHguidelines
n

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