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)
• Strong 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 fast-paced environment
• Excellent communication and problem-solving skills; confident collaborating across teams

Desirable

• Experience incGMP radiopharmaceutical manufacturing
• Familiarity withPIC/S / ICHguidelines

Fuse Recruitment is seeking a Quality Assurance Associate for a leading radiopharmaceutical manufacturer in Brisbane. You will support the implementation, maintenance and continuous improvement of a QMS in a cGMP-regulated environment, partnering with operations and documentation to ensure compliance, quality and safety.

You'll work with cross-functional teams on product lifecycle quality, including validation and verification, change control, deviations and CAPA, ensuring regulatory

Seeking an experienced leader to oversee critical GMP laboratory operations at our Brisbane site. If you excel in driving compliance, continuous improvement, and team performance within a regulated environment, this role offers the scope to make a substantial impact on radiopharmaceutical quality and growth.

• Lead a specialised, technical environment supporting clinical and commercial radiopharmaceutical production
• Directly influence laboratory modernisationand process optimisation initiatives
• Partner closely with manufacturing, quality, and regulatory teams in a collaborative setting
• Play a pivotal role in inspection readiness and regulatory audits for a high-growth sector
• Manage a dedicated team within a high-stakes, site-based environment
• Contribute to innovative projects supporting early and late-stage development

• Lead day-to-day QC laboratory operations, focusing on testing, sample management, and release procedures
• Drive staff leadership, training, and continuously develop QC personnel
• Oversee analytical testing, deviations, investigations, and compliance with GMP and radiation safety standards
• Implement and continuously improve laboratory systems, including LIMS and automation tools
• Manage external laboratory relationships and outsourced activities
• Support strategic projects such as technology transfers and validation initiatives
• Maintain inspection readiness and facilitate internal and external audits

• Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Microbiology, Radiochemistry, or related field
• 8+ years in regulated GMP environments, with at least 3 years managing laboratory teams
• Strong understanding of GMP, data integrity, and quality systems in pharma or biotech
• Experience with analytical techniques like HPLC, chromatography, spectroscopy
• Proven track record supporting regulatory audits and inspections
• Excellent stakeholder management and problem-solving skills

• MSc or PhD in a relevant discipline
• Background in radiopharmaceuticals, nuclear medicine, or radioactive materials
• Experience with LIMS, laboratory automation, or environmental monitoring
• Knowledge of Australian radiation safety and regulatory frameworks
• This role involves site-based shift work and hands on laboratory leadership.

Are you ready to lead microbiology, contamination control, and sterility assurance in a high-growth radiopharmaceutical environment? This is a strategic, hands-on leadership role supporting the manufacturing of sterileproducts, offering exposure to complex GMP operations and regulatory interactions. Perfect for an experienced microbiology or contamination control expert seeking impactful scope and autonomy.

• Lead contamination control strategies in a dedicated GMP manufacturing site with a focus on innovation and continuous improvement
• Influence facility expansion, validation, and technology transfers in a sector with high patient impact
• Play a critical role during regulatory inspections as a site subject matter expert
• Be part of a multidisciplinary team supporting both clinical and future commercial products
• Develop your leadership in a pivotal role that directly supports patient safety

• Lead microbiology, contamination control, environmental monitoring, and sterility assurance programs
• Develop and maintain contamination control strategies aligned with GMP and industry best practices
• Oversee environmental monitoring, including trend analysis and program optimisation
• Support aseptic process simulations, cleanroom qualifications, and contamination assessments
• Lead investigations into microbiological deviations and support CAPA implementation
• Ensure compliance with Australian and international regulatory standards during inspections and audits
• Provide technical leadership and mentorship across microbiology, quality, and manufacturing teams

• Bachelor's degree in Microbiology, Biology, Biochemistry, Biotechnology or related field
• 8+ years in sterile pharmaceutical, biologics, or radiopharmaceutical GMP manufacturing environments
• 3+ years leading contamination control, microbiology, or aseptic processing teams
• Proven experience managing contamination risk assessments and environmental monitoring programs
• Strong knowledge of GMP, Australian TGA standards, and international contamination control best practices
• Excellent communication and stakeholder management skills
• Experience supporting audits, regulatory submissions, and complex investigations

• Advanced training or certifications in microbiology, contamination control, or quality systems
• Experience in radiopharmaceutical manufacturing or nuclear medicine environments
• Knowledge of EU GMP Annex 1, facility start-up, and process validation
• Familiarity with digital environmental monitoring tools and data analytics

Fuse Recruitment is seeking a Sterility Assurance Manager to lead microbiology, contamination control, and sterility assurance within a GMP radiopharmaceutical manufacturing environment. This role offers strategic leadership, hands-on oversight, and interaction with regulatory bodies.

You will drive environmental monitoring, aseptic processing support, and CAPA programs while guiding cross-functional teams across quality and manufacturing. Senior expertise in GMP standards and TGA is essential.