Quality Control Specialist

ARTMS; Angleton (TX); On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

Performance-based bonus

Equity-based incentive program

Generous vacation

Paid wellness days

Learning and development support

Job summary

Telix Pharmaceuticals is a dynamic radiopharmaceutical company with a global footprint, expanding the international rollout of imaging agents. The role focuses on GMP-compliant QC lab operations, data integrity, and treatment of radioactive materials to support batch release and regulatory interactions.

You'll participate in method validation, investigations (OOS), CAPA, and maintenance of QC materials and equipment, while promoting aseptic techniques and strict safety protocols across the

Qualifications

• Bachelor's degree in chemistry, biochemistry, biology, or related field.
• 3+ years of experience in a laboratory role within a GMP environment.
• Experience with aseptic technique in controlled areas is preferred.

Responsibilities

• Execute lab operations to ensure GMP compliance and data integrity.
• Escalate quality events and investigations to management.
• Perform QC testing on radioactive material and review data for batch release.
• Participate in method validation including development and qualification.
• Assist in investigations (OOS), deviations, and CAPA.
• Manage QC materials and laboratory equipment maintenance and calibration.
• Write/update Quality Control procedures and ensure aseptic techniques.
• Support FDA/Regulatory interactions for regulatory submissions and inspections.
• Assist QA and other departments with investigations and timely closure.
• Understand and adhere to GMP policies and procedures.

Skills

Teamwork

Cross-functional collaboration

Communication

Adaptability

Continuous learning

Education

Bachelor's degree in chemistry/biochemistry/biology

Job description

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.

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 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.
• 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.

Qualifications

• 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.

Preferred Skills

• 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.

Benefits

Telix offers competitive salaries, annual performance‑based bonuses, an equity‑based incentive program, generous vacation, paid wellness days and support for learning and development.

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.