Hiring: QA Operations Specialist - Shift Based Company: Novartis Location: Carlsbad, CA Job Posted Time: 2026-09-03 10:21:07 About the job Experience: •3 years of experience in GxP biopharmaceutical or active pharmaceutical ingredient (API) manufacturing operations. •2 years of experience in a Quality Assurance role within a regulated environment. •Minimum 3 years of experience in GxP biopharmaceutical or active pharmaceutical ingredient (API) manufacturing operations. •Minimum 2 years of experience in a Quality Assurance role within a regulated environment. Required Skills: •Provide Quality Assurance support for manufacturing, quality control, engineering, and supply chain operations. •Review and approve test records for batch release, SOPs, CAPAs, Deviations, OOX investigations, Quality Risk Assessments, Quality Plans/Events, protocols, and change controls. •Perform shop floor oversight and provide compliance guidance supporting operational decision-making. •Conduct live batch record review and execute acceptable quality limit inspections. •Support continuous quality improvement initiatives that enhance manufacturing quality, compliance, and operational efficiency. •Support regulatory inspection readiness, execute inspection activities, and maintain ongoing site cGMP compliance. •Deliver quality training and collaborate across teams to strengthen quality culture and performance. Qualifications: •Bachelor’s degree in Life Sciences, Chemistry, or a related relevant degree. •Quality Assurance or Quality Control experience in pharmaceutical environments with environmental monitoring and cleanliness zones. •Proven ability to collaborate effectively across functions and build strong working relationships. •To learn more about the culture, rewards and benefits we offer our people click here. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!