Quality Control Specialist

About the role

The QC Specialist will execute analytical and biological testing in support of GMP manufacturing operations at Telix Pharmaceuticals' radiopharmaceutical facility. This role requires executing test methods as written, escalating any issues or deviations to management, and adhering to GDP/GMP/GLP principles.

Responsibilities

• Execute lab operations to ensure compliance with GMP principles, data integrity, and good lab practices as applicable.
• Timely escalate all quality events and investigations to management.
• 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.
• Perform method validation activities including method development and qualification.
• Review QC testing data for accuracy to support batch release process (including mAbs and small molecules).
• Participate in laboratory investigations (OOS), deviations, change control, and implement corrective/preventive actions.
• Manage QC material (consumables and chemicals).
• Manage laboratory equipment (maintenance, calibration, qualification, requalification, installation).
• Write and update Quality Control procedures.
• Ensure compliance of site personnel and application of aseptic techniques and GMP principles.
• Support FDA/Regulatory interactions for Angleton site activities and products.
• Assist QA and other departments with investigations and timely closure of investigations.

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.

Qualifications

Education and experience requirements as outlined above.

Skills

Inclusive mindset, creativity and innovation, commitment to excellence, results-oriented, ethical behavior, adaptability, strong communication skills, collaboration, resilience, continuous learning.

Benefits

Competitive salaries, annual performance-based bonuses, an equity-based incentive program, generous vacation, paid wellness days, and support for learning and development.

Pay

N/A

Schedule

N/A

Skills

Strong communication skills, ability to work in a team environment, willingness to work with radioactive materials, adherence to GMP principles, ability to perform aseptic technique in controlled areas, cross-functional collaboration, ability to identify areas of improvement, ability to participate in laboratory investigations, ability to manage QC material and equipment, ability to write and update Quality Control procedures, ability to support FDA/Regulatory interactions, ability to assist QA and other departments with investigations and closure of investigations.