Telix Pharmaceuticals is seeking a Quality Assurance Associate to support quality activities and GxP compliance at its Angleton manufacturing site. The role focuses on operational quality processes, documentation, audits, product disposition, regulatory readiness, and collaboration across manufacturing and supply chain teams.
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 activitiesPerform 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
Qualification
Required
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
Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language
Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals
Preferred
Benefits
Hybrid and remote work arrangements
Annual performance-based bonuses
Equity-based incentive program
Generous vacation
Paid wellness days
Support for learning and development
Telix is a global biopharmaceutical company focused on the development and commercialization of radiopharmaceuticals to address significant unmet medical need in oncology and rare diseases.
