Operational Area Senior Quality Specialist (Contract) 29503

Vertex Pharmaceuticals•Boston, MA

1d•$55 - $65

About The Position

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.

Requirements

Bachelor’s degree in a scientific or allied health field or the equivalent combination of education and experience
Experience providing QA support and oversight of GMP manufacturing operation
Experience successfully leading event investigations, Root Cause Analysis and CAPA
Experience with network-based applications such as Oracle, TrackWise, Veeva
Knowledge of current industry trends and ability to use the latest technologies

Responsibilities

Reviews and approves investigations, CAPA’s and change controls
Acts as Quality Owner for deviations, including review and approval of associated CAPA, and coordinates with Manufacturing Technical Ops (MTO) to ensure assignment within QA team for minor quality events.
Assists Change Control owners with ensuring compliance to change procedure requirements, assesses and approves change controls as Quality
Quality triage and impact assessor of investigations/deviations, reviews corrective action plans for adequacy and compliance. This includes root cause analysis and product impact assessments for investigations.
Ensures appropriate CAPA actions are identified and addressed.
Communicates proactively with internal partners and management.
Escalate critical and major finding to Quality management and monitor key performance indicators in collaboration with Quality Systems and other GXP Operational areas.