Quality Assurance Associate
Telix Pharmaceuticals (Americas)
Summary
We are seeking a highly motivated and detail-oriented Quality Assurance Associate to join our radiopharmaceutical quality team. The QA Associate supports Quality aspects and activities within their area of responsibility, helping to ensure and support overall GxP conformity and Compliance with the Telix IsoTherapeutics Quality Management Systems for the Angleton manufacturing site with a focus on operational activities.
Job description
Key Accountabilities
- Understand and adhere to GMP Policies
- Prepare, review, and maintain quality documents within the QMS (MasterControl), including document control and lifecycle support
- Support training management, ensuring training matrices and records are accurate and up to date in the QMS
- Support internal and external audits, supplier quality activities, and CMO oversight, including document reviews, audits participation, and quality agreements
- Assist functional areas with achieving timely and compliant final product dispositions of the product being manufactured
- Participate in writing and implementing Deviations, Investigations, CAPA Change Control and complaint reports and ensure timely, compliant closure
- Support compliance of site personnel with aseptic techniques and sterile manufacturing requirements
- Participate in the management of supplier, vendor assurance activities and supplier quality agreements
- Support FDA/regulatory inspection readiness and assist with site regulatory activities
- Perform QA Operations as a valued business partner, with a culture of safety, quality, delivery to patients, cost, compliance and data integrity
- Collaborate with manufacturing, supply chain, and cross-functional teams, supporting batch review, batch release activities, and continuous improvement of the QMS
Education and Experience
- Bachelor's degree in Life Sciences, Quality Management, or related field
- 1+ year of experience in quality assurance role
- Experience in GxP sterile manufacturing operations is requested
- Cross functional collaboration is a requirement for the position
- Ability to work in a team environment and communicate effectively with diverse groups
- Willingness to work with radioactive materials and follow strict safety protocols is required
- Technical understanding of manufacturing, quality and regulatory requirements
- Previous experience writing and reviewing with understanding SOPs and specifications
Key Capabilities
- Commitment to excellence
- Results-oriented
- Creativity and innovation
- Strong communication skills
- Collaboration
- Resilience
- Inclusive mindset
- Adaptability
- Ethical behavior
- Continuous learning
Requirements
- Bachelor's degree in Life Sciences, Quality Management, or related field
- 1+ year of experience in quality assurance role
- Experience in GxP sterile manufacturing operations
- Cross functional collaboration
- Ability to work in a team environment and communicate effectively with diverse groups
- Willingness to work with radioactive materials and follow strict safety protocols
- Technical understanding of manufacturing, quality and regulatory requirements
- Previous experience writing and reviewing SOPs and specifications
Benefits
- Competitive Salaries
- Annual Performance-Based Bonuses
- Equity-Based Incentive Program
- Generous Vacation
- Paid Wellness Days
- Learning & Development Support
Company overview
Telix Pharmaceuticals (Americas) is the United States operations division of Telix Pharmaceuticals Limited, a global commercial-stage biopharmaceutical company specializing in the development and commercialization of therapeutic and diagnostic radiopharmaceuticals, commonly known as 'theranostics'. Headquartered in Melbourne, Australia with global operations spanning the United States, Europe, and Japan, Telix focuses on precision oncology through targeted radiation therapies. The company's innovative pipeline addresses significant unmet medical needs in urologic oncology (prostate and kidney cancer), neuro-oncology (glioma), musculoskeletal oncology (sarcoma), and bone marrow conditioning. Telix has achieved regulatory approvals from the FDA, TGA, and Health Canada for its prostate cancer imaging agent Illuccix®, and maintains an extensive portfolio of over 18 clinical trials worldwide. As a dynamic, fast-growing radiopharmaceutical company, Telix Pharmaceuticals (Americas) plays a crucial role in the international rollout of approved products and advancement of late clinical-stage therapies, leveraging a global workforce of 1,000-5,000 employees dedicated to improving quality of life for cancer patients through targeted radiation solutions.