Quality Assurance Associate
- Maintain and improve the Quality Management System in a cGMP-regulated manufacturing environment, including documentation, batch record review and quality investigations.
- Support change control, deviations, CAPA, validation and verification activities, and compliance with regulatory and radiation safety requirements.
- Collaborate with operations and other teams on quality planning, product lifecycle activities and continuous improvement.
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 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
How to apply Apply with your CV highlighting your QA experience.
Consultant
Sam Standfast
Senior Recruitment Consultant
0412 638 890
sstandfast@fuserecruitment.com
https://www.linkedin.com/in/samstandfast/
Reference number: BH-39857
Profession:Manufacturing & OperationsQuality Assurance & Control
Company: Fuse Recruitment
Date posted: 4th Nov, 2026
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