Quality Assurance Associate
Telix Pharmaceuticals Limited
June 25, 2026
On-site
Angleton, TX
Operations
QA Operations Specialist
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; ensure training matrices and records are accurate and up to date in the QMS.
- Support internal/external audits, supplier quality activities, and CMO oversight (document reviews, audit participation, quality agreements).
- Assist functional areas to achieve timely and compliant final product dispositions.
- Write, implement, and approve Deviations, Investigations, CAPA, change control, and complaint reports; ensure timely, compliant closure.
- Ensure site personnel compliance, application of aseptic techniques, and compliance to sterile manufacturing regulations.
- Participate in supplier/vendor assurance and supplier quality agreements.
- Lead FDA/Regulatory interactions for Angleton site activities to support successful submissions and inspections.
- Perform QA Operations as a business partner focused on safety, quality, delivery to patients, cost, compliance, and data integrity.
- Collaborate with manufacturing, supply chain, and cross-functional teams on batch review/release and continuous QMS improvement.
Education and Experience/Requirements
- Bachelor’s degree in Life Sciences, Quality Management, or related field.
- 3+ years in quality assurance.
- Experience in GxP sterile manufacturing operations.
- Cross-functional collaboration experience.
- Ability to work in a team environment and communicate effectively.
- Willingness to work with radioactive materials and follow strict safety protocols.
- Technical understanding of manufacturing, quality, and regulatory requirements.
- Experience writing/reviewing SOPs and specifications.
Key Capabilities
- Inclusive mindset, creativity/innovation, commitment to excellence, results-oriented, ethical behavior, adaptability, strong communication, collaboration, resilience, continuous learning.
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; ensure training matrices and records are accurate and up to date in the QMS.
- Support internal/external audits, supplier quality activities, and CMO oversight (document reviews, audit participation, quality agreements).
- Assist functional areas to achieve timely and compliant final product dispositions.
- Write, implement, and approve Deviations, Investigations, CAPA, change control, and complaint reports; ensure timely, compliant closure.
- Ensure site personnel compliance, application of aseptic techniques, and compliance to sterile manufacturing regulations.
- Participate in supplier/vendor assurance and supplier quality agreements.
- Lead FDA/Regulatory interactions for Angleton site activities to support successful submissions and inspections.
- Perform QA Operations as a business partner focused on safety, quality, delivery to patients, cost, compliance, and data integrity.
- Collaborate with manufacturing, supply chain, and cross-functional teams on batch review/release and continuous QMS improvement.
Education and Experience/Requirements
- Bachelor’s degree in Life Sciences, Quality Management, or related field.
- 3+ years in quality assurance.
- Experience in GxP sterile manufacturing operations.
- Cross-functional collaboration experience.
- Ability to work in a team environment and communicate effectively.
- Willingness to work with radioactive materials and follow strict safety protocols.
- Technical understanding of manufacturing, quality, and regulatory requirements.
- Experience writing/reviewing SOPs and specifications.
Key Capabilities
- Inclusive mindset, creativity/innovation, commitment to excellence, results-oriented, ethical behavior, adaptability, strong communication, collaboration, resilience, continuous learning.