JobMesh

Operational Quality Senior Specialist (Contract) 28773

Vertex Pharmaceuticals · Boston, Massachusetts, US

Job Description The operational Area Senior Quality Specialist will provide QA support of manufacturing operations, analytical laboratory operations and mate...

Job description

Job Description The operational Area Senior Quality Specialist will provide QA support of manufacturing operations, analytical laboratory operations and materials management for the external manufacturing programs at VCGT. This role will review batch data, including batch records, deviations, in-process data, EM data, QC release testing and other quality systems documentation as needed in support of product disposition. KEY RESPONSIBILITIES: - Reviews executed batch records and provides customer approval for quality tasks for externally manufactured products - Performs final review of executed batch and/or critical systems documentation and determines acceptability by using standard operating procedures - Ensures presence and acceptability of all required documentation prior to the release of the product and/or system - Support the day-to-day management of the batch release process - Assist the facility in preparation for quality audits and participate in corporate audits and external inspections as needed - Communicates proactively with internal and external patterns and management - Maintains files such that documents are readily available and easily retrievable - Assists departm...