lottebiologicsusallc · Syracuse, NY
We are LOTTE BIOLOGICS ! Delivering Therapies That Enable a Healthier World . A new company, built on 80 years of tradition. We embody our core values of being Inspired by Science , Embracing Diversity , Fostering Talent , and Connecting Lives . Our mission is to be the most trusted partner in the industry, with high standards of quality and continuous innovation, to reliably deliver benefits for patients worldwide. Position Summary The Sr. Specialist, QA Program Management is responsible for executing and supporting client-related Quality Assurance activities within a CDMO environment, providing quality oversight to internal stakeholders during new product introductions, technical transfers, and lifecycle management for existing products. This role supports client programs by ensuring internal alignment with site procedures, client requirements and Quality Agreements by applying specialized knowledge of cGMP regulations. The role executes assigned QA deliverables, including document review and approval, and provides on-the-floor manufacturing Quality oversight to ensure compliant and efficient operations. This role is responsible for the execution and QA oversight of deviations, ensuring timely investigation, documentation, and closure, as well as supporting and overseeing client-specific change control activities, including recommendation, review, and approval of actions. The Sr. Specialist also supports implementation of client requirements through internal processes and contributes to broader site Quality and operational initiatives as needed. This role requires the application of scientific and quality principles to interpret established standards, assess documentation and quality information, and support compliant decision-making in a cGMP-regulated environment. Duties & Responsibilities Execute assigned QA activities for the Quality organization to enable successful new product introductions (NPI) and technical transfer projects, and lifecycle management acti…
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