The QA Specialist for External Quality will be responsible, with management support, for providing oversight of quality activities associated with drug substance, drug product and finished product manufacturing processes to contract manufacturing organizations. The Specialist contributes and guides the completion of milestones associated with specific projects and supports ongoing quality assurance responsibilities in support of: Contract Manufacturing oversight and quality systems including Change Control, Deviations and CAPA’s. Acts independently to determine methods and procedures on new assignments and provides guidance to lower-level personnel. Performs’ all responsibilities in accordance with company policies, procedures, and regulations.
This role requires 20% travel
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