Full time
Vertex Pharmaceuticals
Boston, MA, USA
Job Description: The Operational Area Senior Quality Specialist will provide QA support for manufacturing operations, analytical laboratory operations and materials management for external manufacturing programs at VCGT. This role will review batch data, including batch records, deviations, in-process data, EM data, QC release and stability testing and other quality systems documentation as needed in support of product disposition. Key Responsibilities : Reviews master batch records and provide customer approval for quality tasks for externally manufactured products Reviews analytical laboratory testing data including method validation and QC testing with providing customer approval for externally manufactured products. Performs final review of executed batch and/or critical systems documentation including certificate of analysis / certificate of conformance and determines acceptability by using standard operating procedure Ensures presence and acceptability of all...


