Senior Quality Specialist
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About The Position
The Senior Quality Specialist is a member of the Quality group providing support for all aspects of Development, Phase I-IV clinical, scale-up activities, and commercial manufacturing, testing, and release, as applicable. This role supports internal and external quality operations and systems, including facility/equipment, utilities, materials, production, laboratory, packaging/labeling, and general compliance. The position assures compliance with current domestic and international GMPs and regulatory agencies. The Senior Quality Specialist contributes to and may lead operational teams in the development, management, harmonization, and improvement of quality systems and procedures. This role also assists in decision-making that requires developing options to solve moderate to complex issues.
