Quality Control Specialist

Overview

Telix Pharmaceuticals is a dynamic, fast‑growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver precision medicine through targeted radiation and to improve the quality of life for people living with cancer and rare diseases. We are supporting the international roll‑out of our approved prostate cancer imaging agent and advancing a portfolio of late‑clinical‑stage products.

We are seeking a highly motivated and detail‑oriented QC Specialist to join our team. The QC Specialist will execute analytical and biological testing in support of GMP manufacturing operations at our radiopharmaceutical facility, execute test methods as written,‐escalate any issues or deviations to management, and follow all GDP/GMP/GLP principles as applicable.

• Execute lab operations to ensure compliance with GMP principles, data integrity, and good lab practices.
• Ensure timely escalation to management for all quality events and investigations. Lab activities cover QC testing on radioactive material.
• Experience in specific QC techniques such as HPLC, GC, TLC, ELISA, or CE‑SDS.
• Continually identify areas of improvement for the lab and testing processes.
• Independently complete all routine documentation in compliance with GDP.
• Execute method validation activities including method development and qualification.
• Perform review of QC testing data for accuracy to support the batch release process (including mAb and small molecule).
• Participate in laboratory investigations (OOS), deviations, change control, and implement the associated corrective/preventive actions.
• Participate in management of QC material (consumables and chemicals).
• Participate in management of laboratory equipment (maintenance, calibration, qualification, requalification, installation).
• Participate in writing and updating Quality Control procedures.
• Ensure compliance of site personnel with aseptic techniques and GMP principles.
• Support FDA/Regulatory interactions for the Angleton site activities and products to ensure successful regulatory submissions and inspections.
• Assist QA and other departments with investigations and the timely closure of investigations.
• Understand and adhere to GMP policies and procedures.
• Other related duties as assigned.

• Minimum of a Bachelor’s degree in chemistry, biochemistry, biology, or a related field.
• 3+ years of experience in a laboratory role within a GMP environment.
• Experience in GxP manufacturing operations is preferred.
• Experience performing aseptic technique in controlled areas is preferred.
• 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.

• Inclusive mindset:
  Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment.
• Creativity and innovation:
  Think outside the box and develop unique solutions.
• Commitment to excellence:
  Take pride in your work and consistently strive for excellence.
• Results‑oriented:
  Drive to achieve goals and objectives with a focus on measurable results.
• Ethical behavior:
  Act with integrity and commitment to ethical behavior.
• Adaptability:
  Comfortable working in a dynamic environment, able to adjust to changing priorities and take on new challenges.
• Strong communication skills:
  Communicate effectively with colleagues and stakeholders at all levels.
• Collaboration:
  
  Work effectively as part of a team, sharing knowledge and expertise.
• Resilience:
  Bounce back from setbacks and persevere in the face of challenges.
• Continuous learning:
  Commit to ongoing learning and professional development.

Telix offers competitive salaries, annual performance‑based bonuses, an equity‑based incentive program, generous vacation, paid wellness days, and support for learning and development. We support a hybrid and remote working model with employees located worldwide.

Telix Pharmaceuticals is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.