Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medicine through targeted radiation. At our core, we exist to create products that seek to improve the quality of life for people living with cancer and rare diseases. You will be supporting the international roll-out of our approved prostate cancer imaging agent and helping us to advance our portfolio of late clinical-stage products that address significant unmet need in oncology and rare diseases.
See Yourself at Telix
The Quality Associate reports to the Quality Manager, supporting the ARTMS Quality Management System including Change Control, NCs, CAs, Audits, Supplier Management, Risk Management and the release of Approved Products. The role shall interact closely with all key functional groups and teams withing the organization.
Key Accountabilities
- QA review and release of ARTMS products for customer use
- Contributing to the continuous improvement of the ARTMS QMS and applying Risk-Based Thinking to address Risks and Opportunities
- Creation, review and approval Quality Documentation (Quality Manual, Procedures/Work Instructions) and Records (Batch Records, Inspection Records) and ensuring consistent GDP is applied
- Ensuring products and raw materials are adequately controlled and monitored
- Creating, approving and managing Nonconformity Records and ensuring products are dispositioned a timely manner
- Creating, approving and managing Corrective Actions Records and ensuring they are closed in a timely manner
- Provide training to ARTMS staff on QMS processes, objectives and tools
- Assist in the development of inspection documents for incoming raw materials/assemblies, in process materials and finished products
- Work with Operations, Product Development, Chemistry and External Suppliers to ensure product and material performance is adequately monitored and specifications are met
- Champion problem solving and root cause analysis activities with internal and external suppliers and customers to eliminate recurrence of non‐conformances
- Address in-process quality issues in a timely manner to ensure continuity of production and supply
- Participate in the ARTMS audit program
- Generate reports and analyze data to assist with development, implementation and sustainment of policies and processes
- Other duties may be assigned as needed
Education and Experience
- Post-secondary technical degree (Science/Engineering) with continuing education/training required
- 2+ years experience in a Regulated Quality environment required
- Working Knowledge of quality systems/cGMP; ISO 9001, ISO 13485, 21CFR 211, 21CFR 212
- Knowledge of commonly used Quality Assurance concepts, practices and procedures in a manufacturing environment
- Ability to work in a cross-functional team environment
- Proficient in Microsoft Office Suite including Word and Excel
At Telix, we believe everyone counts, we strive to be extraordinary, and we pursue our goals with determination and integrity. You will be part of an engaged and supportive group of colleagues who all have a shared purpose: to help people with cancer and rare diseases live longer, better quality lives. Being a Telix employee means being a part of a unique, global, interdisciplinary team working to deliver what's next in precision medicine. We have hybrid and remote employees located all around the world. We offer competitive salaries, annual performance-based bonuses, an equity-based incentive program, generous vacation, paid wellness days and support for learning and development.
Telix Pharmaceuticals is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.
VIEW OUR PRIVACY POLICY HERE
What We Do
Telix is a biopharmaceutical company focused on the development and commercialisation of diagnostic and therapeutic ('theranostic') radiopharmaceuticals. Telix is headquartered in Melbourne, Australia with commercial operations in the United States, Europe (Belgium and Switzerland) and Japan. Telix is developing a portfolio of radiopharmaceutical products that aims to address significant unmet medical need in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX)
