Quality Control Specialist
Telix Pharmaceuticals Limited
June 25, 2026
On-site
Angleton, TX
Operations
QC Specialist
Responsibilities:
- Execute analytical and biological testing in support of GMP manufacturing operations at a radiopharmaceutical facility.
- Execute test methods as written and follow applicable GDP/GMP/GLP principles.
- Ensure GMP compliance, data integrity, and good lab practices.
- Escalate quality events and investigations to management; QC testing covers radioactive material.
- Independently complete routine documentation in compliance with GDP.
- Execute method validation activities, including method development and qualification.
- Review QC testing data for accuracy to support batch release (including mAb and small molecule).
- Participate in/perform OOS investigations, deviations, change control, and implement corrective/preventive actions.
- Support management of QC materials (consumables/chemicals) and laboratory equipment (maintenance, calibration, qualification, requalification, installation).
- Write and update Quality Control procedures.
- Ensure aseptic technique and GMP compliance by site personnel.
- Support FDA/regulatory interactions for Angleton site activities and products; assist QA and other departments with timely closure of investigations.
Qualifications:
- Minimum Bachelor’s degree in chemistry, biochemistry, biology, or related field.
- 3+ years of laboratory experience in a GMP environment.
- Preferred: GxP manufacturing operations experience.
- Preferred: aseptic technique in controlled areas.
- Required: cross-functional collaboration; ability to work in teams and communicate effectively.
- Willingness to work with radioactive materials and follow safety protocols.
Skills/Experience:
- QC techniques such as HPLC, GC, TLC, ELISA, and CE-SDS.
Responsibilities:
- Execute analytical and biological testing in support of GMP manufacturing operations at a radiopharmaceutical facility.
- Execute test methods as written and follow applicable GDP/GMP/GLP principles.
- Ensure GMP compliance, data integrity, and good lab practices.
- Escalate quality events and investigations to management; QC testing covers radioactive material.
- Independently complete routine documentation in compliance with GDP.
- Execute method validation activities, including method development and qualification.
- Review QC testing data for accuracy to support batch release (including mAb and small molecule).
- Participate in/perform OOS investigations, deviations, change control, and implement corrective/preventive actions.
- Support management of QC materials (consumables/chemicals) and laboratory equipment (maintenance, calibration, qualification, requalification, installation).
- Write and update Quality Control procedures.
- Ensure aseptic technique and GMP compliance by site personnel.
- Support FDA/regulatory interactions for Angleton site activities and products; assist QA and other departments with timely closure of investigations.
Qualifications:
- Minimum Bachelor’s degree in chemistry, biochemistry, biology, or related field.
- 3+ years of laboratory experience in a GMP environment.
- Preferred: GxP manufacturing operations experience.
- Preferred: aseptic technique in controlled areas.
- Required: cross-functional collaboration; ability to work in teams and communicate effectively.
- Willingness to work with radioactive materials and follow safety protocols.
Skills/Experience:
- QC techniques such as HPLC, GC, TLC, ELISA, and CE-SDS.