Quality Control Specialist

See Yourself at Telix

We are seeking a highly motivated and detailed 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. In this role you must be able to execute test methods as written, escalate any issues or deviations to management, and follow all GDP/GMP/GLP principles as applicable.

Key Accountabilities:

• Execute lab operations to ensure compliance with GMP principles, data integrity, and good lab practices as applicable.
• 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 or Elisa, CE-SDS.
• Continually identify areas of improvement for the lab and testing processes.
• Independently completes 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 / Perform laboratory investigations (OOS), deviations, Change control and implement the associated corrective/preventive actions.
• Participation in management of QC material (consumables and chemicals)
• Participation in management of laboratory equipment (maintenance, calibration, qualification, requalification, installation).
• Participate in writing and updating Quality Control procedures.
• Ensure compliance of site personnel and application of 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.

Education and Experience:

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

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 out opportunities to expand your knowledge and skills