We are seeking a Senior Quality Assurance (QA) Associate who will support the implementation and maintenance of the Quality Management System (QMS) to meet current Good Manufacturing Practice (cGMP), industry standards and applicable guidelines which are required to meet quality and regulatory requirements and guidelines such as TGA, FDA, EMA or other relevant regulatory agencies.

Responsibilities Oversee and execute QA processes including batch record reviews, deviation investigations, and CAPA (Corrective and Preventive Action) implementation

Provide support to ensure the company’s compliance with regulatory requirements, company policies, and cGMP standards

Participate in internal and external audits, including preparation, facilitation, and follow-up on findings

Complete and maintain accurate production records and documentation, including inventory levels, batch records and associated reports, in accordance with applicable guidelines such as cGMP requirements

Participate in the development and validation of manufacturing processes for new and existing radiopharmaceutical products by working closely with R&D; and Regulatory Affairs teams

Participate in production planning meetings, providing input and insights to support strategic decision-making

Support the development, review, and approval of Standard Operating Procedures (SOPs) and other controlled documents

Contribute to quality risk management activities and facilitate root cause analyses for quality issues

Identify opportunities for process improvements within the quality management system and participate in their implementation

Work closely with R&D;, Engineering, and CMC teams to address quality-related issues and support new product introductions, ensuring compliance with regulatory requirements, including such as TGA, FDA, EMA or other relevant regulatory agencies throughout the product lifecycle

Prepare and analyse complex data,



as well as identify trends and patterns in the data in relation to quality management processes

Assist with the preparation of quality reports, including Annual Product Reviews and regulatory submissions

Present and explain Quality insights to key stakeholders, including technical and non-technical stakeholders

Drive continued improvements and automation of the company’s pipeline products and processes

Stay informed of evolving regulatory guidelines and industry best practices, incorporating them into company processes Other Responsibilities This role supports time-critical radiopharmaceutical manufacturing operations and requires flexibility to work early morning shifts, with occasional adjustments to working hours to meet production and operational requirements

Observe the Company’s workplace, health and safety, and regulatory policies and procedures

Engage and communicate with other AdvanCell business unit staff to ensure that activities are undertaking seamlessly and effectively

Adhere to the Company’s quality management system processes and policies. Experience, Education & Qualifications Bachelor's degree in chemistry, engineering, pharmaceutical sciences or relevant discipline

Minimum of 5 years of experience in quality assurance or quality management, preferably in the radiopharmaceutical industry or sterile manufacturing environments

Solid technical knowledge of radiopharmaceutical manufacturing processes, equipment and quality control principles. Knowledge and understanding of cGMP regulations, TGA, FDA & EMA guidelines, and radiation safety regulations applicable to radiopharmaceutical manufacturing

Demonstrated ability to work to timelines and in high pressure situations. Excellent communication skills and strong analytical problem-solving skills, with the ability to collaborate effectively across departments and communicate with stakeholders at all levels

Experience in cGMP manufacture of radiopharmaceuticals

📌 Senior Quality Assurance Associate (Brisbane City)
🏢 Advancell
📍 Brisbane City