The responsibilities of the Specialist, Quality Assurance include, but are not limited to, the support of batch record management, retrieval and generation of batch conformance documentation (CoC and CoA), completion of batch record reviews for domestic market, intermediate and finished product releases for domestic market, support site Quality owned investigations, data compilation/support for internal/external audits and regulatory inspections, SOP development and review, Supplier Quality Management and other Quality Assurance related functions as required. The Specialist must demonstrate strong leadership capability, critical thinking skills, and the ability to work independently to ensure job responsibilities are conducted in a timely and reliable manner to meet production demands.
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