Senior Quality Specialist

Description

We're looking for a Senior Quality Specialist, working in the Pharmaceuticals and Medical Products industry in 210 Welsh Pool Road, Exton, Pennsylvania, 19341, United States.

Responsibilities:

• Provides quality assurance support of validation, manufacturing, and testing of clinical trials materials and serves as a quality assurance resource for the Pilot Plant staff.
• Provides quality support within the Pilot Plant in the execution of key quality systems, including equipment, system, and utility validation, SIP, Autoclave, and ongoing process improvement efforts.
• Provides quality support to processes such as batch release, deviation and CAPA management, facility management/maintenance processes, validation, and change management.
• Provides review of technical, validation, and other protocols and reports, with emphasis on adherence to quality systems, and with FDA, EMEA, ICH, and JP regulations/guidance.
• Maintains Quality systems while ensuring seamless and efficient efforts are applied to ongoing validation, maintenance, automation, and change management processes while ensuring compliance with established policies and procedures.