Quality Control Specialist

Telix Pharmaceuticals (AMER)•Angleton, TX

20h•Hybrid

About The Position

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 on the promise of precision medicine through targeted radiation. At our core, we exist to create products that seek to improve the quality of life for people living with cancer and rare diseases. You will be supporting the international roll-out of our approved prostate cancer imaging agent and helping us to advance our portfolio of late clinical-stage products that address significant unmet need in oncology and rare diseases. 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.

Requirements

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.

Nice To Haves

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

Responsibilities

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.