QA Operations Specialist

Job description

Job Description Summary About this role: Help reimagine cancer care by shaping how our Radioligand Therapies (RLT) reach more patients—safely, reliably, and faster. At Novartis, we’re pioneering the future of treatment through the fusion of nuclear medicine and precision oncology. Our QA Operations Specialist manages Quality aspects and projects within area of responsibility as well as ensuring and supporting overall GxP conformity and Compliance with the Novartis Quality Management Systems for the Indianapolis manufacturing site. Location: Carlsbad, CA #LI-Onsite: Shift: This position involves shift work which will be defined through site start up and commercialization readiness. 12-hour shifts and weekends will be required. Job Description: Key Responsibilities: - Provide QA support of production, QC, engineering, and supply chain operations through review/approval of test records for batch release, SOPs, CAPAs, Deviations, OOX investigations, Quality Risk Assessments, Quality Plans/Events, protocols, and change controls. Additionally, provide shop floor oversight with QA/compliance guidance to support decision-making throughout these processes. - Manufacturing support includes l...