Quality Assurance Associate

Telix Pharmaceuticals (AMER)•Angleton, TX

20h

About The Position

Telix Pharmaceuticals is seeking a motivated, detail-oriented Quality Assurance Associate to support quality activities for its Angleton manufacturing site. The role helps ensure GxP conformity and compliance with the Telix Isotherapeutics Quality Management System, with a focus on operational activities. The associate will support the international rollout of an approved prostate cancer imaging agent and the development of late clinical-stage products for oncology and rare diseases. The role works with manufacturing, supply chain, and other cross-functional teams to support quality operations, batch review and release, regulatory readiness, and continual improvement of the quality management system. The position requires collaboration in a sterile manufacturing environment and willingness to work with radioactive materials while following safety protocols.

Requirements

Bachelor's degree in Life Sciences, Quality Management, or a related field.
At least 1 year of experience in a quality assurance role.
Experience in GxP sterile manufacturing operations.
Cross-functional collaboration skills.
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.

Responsibilities

Understand and adhere to GMP policies.
Prepare, review, and maintain quality documents in the QMS (MasterControl), including document control and lifecycle support.
Support training management and keep training matrices and records accurate and up to date in the QMS.
Support internal and external audits, supplier quality activities, and CMO oversight, including document reviews, audit participation, and quality agreements.
Assist functional areas with timely and compliant final product dispositions.
Participate in writing and implementing deviation, investigation, CAPA, change-control, and complaint reports, and ensure timely, compliant closure.
Support site personnel's compliance with aseptic techniques and sterile manufacturing requirements.
Participate in supplier and vendor assurance activities and supplier quality agreements.
Support FDA and regulatory inspection readiness and assist with site regulatory activities.
Perform QA Operations as a business partner, supporting safety, quality, delivery to patients, cost, compliance, and data integrity.
Collaborate with manufacturing, supply chain, and cross-functional teams to support batch review, batch release activities, and continuous improvement of the QMS.