Senior Specialist, QA

The Commercial Quality Specialist is responsible for independently providing Commercial Quality support in the affiliate.  Scope of activities includes quality system requirements associated with:  pharmaceutical products, medical devices, combination products, biologics and cosmetics.  Specific areas of support may include Storage and Distribution, potential quality events/product shortage execution, Supplier Controls, Product Quality Review, Risk Management, Agency inspections/internal audits, CAPA, and overall Quality Manual requirements.  The Sr. Specialist has an in- depth knowledge of one or more elements and is considered a subject matter expert in these areas.  This position will ensure that all product, process or system related quality activities supporting the business at the affiliate from receipt of final product through distribution are in compliance with Corporate, governmental, and local reg...

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