Quality Control Specialist

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. #J-18808-Ljbffr