Quality Assurance Associate

 

See Yourself at Telix

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 lsoTherapuetics Quality Management Systems for the Angleton manufacturing site with a focus on operational 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 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.

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: 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
• Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to 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
• Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
• Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges
• Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders
• Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills