Quality Assurance Associate

See Yourself at Telix

We are seeking a highly motivated and detail-oriented QA Operations Specialist to join our radiopharmaceutical quality team. Our QA Operations Lead manages Quality aspects and projects within area of responsibility as well as ensuring and supporting overall GxP conformity and Compliance with the IsoTherapuetics Quality Management Systems for the Angleton manufacturing site with a focus on the operation activities.

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, implementing and approving Deviations, Investigations, CAPA Change Control and complaint reports and ensure timely, compliant closure.
• Ensure compliance of site personnel and application of aseptic techniques and full compliance to sterile manufacturing regulations.
• Participate in the management of supplier, vendor assurance activities and supplier quality agreements.
• Lead FDA/Regulatory interactions for the Angleton site activities and products to ensure successful regulatory submissions and inspections.
• 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
• 3+ years 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:

• Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected,
• Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges,
• Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do,
• Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results,
• Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders,
• Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges,
• 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,
• Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges,
• Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking opportunities to expand your knowledge and skills.