Quality Control Specialist

AMER•Angleton, TX

3d•Onsite

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. 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.

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.
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.
Experience in specific QC techniques such as HPLC, GC, TLC or Elisa, CE-SDS.
Experience performing proper aseptic technique in controlled areas is preferred.

Nice To Haves

Experience in GxP manufacturing operations is preferred.

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.
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.