QA Operations Specialist - Shift Based

Role: QA Operations Specialist supporting manufacturing, quality control, engineering, and supply chain for radioligand therapies at Novartis. Primary objectives include ensuring product quality, compliance, and manufacturing excellence in a fast-paced GMP environment. Responsibilities encompass reviewing and approving batch release test records, SOPs, CAPAs, deviations, and change controls; conducting shop floor oversight and supporting regulatory inspection readiness; executing quality inspections; and promoting continuous quality improvement initiatives. The role requires collaboration across functions to uphold cGMP standards and foster a quality-centric culture. Requirements: Bachelor’s in Life Sciences, Chemistry, or related field; minimum 3 years in GxP biopharma or API manufacturing; at least 2 years in QA within a regulated environment; experience with environmental monitoring, batch record review, compliance support, and regulatory inspections. Preferred skills include experience supporting operational excellence projects and cross-functional collaboration. High-Value: radioligand therapies, GMP manufacturing, cGMP compliance, batch record oversight, regulatory inspection support, and continuous improvement in a biologics or pharmaceutical setting. Work setup: 12-hour rotating shifts (Wednesdays–Saturdays), with periodic overtime; location: Carlsbad, California.