Operational Area Quality Senior Specialist (Contract)

Vertex Pharmaceuticals • Boston, MA

5d • $61 - $69 • Hybrid

About The Position

The GMP Operational Quality Senior Specialist supports the principles and application of quality assurance and regulatory compliance. The incumbent supports or executes a wide range of straightforward activities and supports new/existing project initiatives. This individual is primarily responsible for coordinating the delivery of Annual Product Quality Review (APQR) and Quarterly Product Quality trending.

Requirements

• Experience with event investigations (deviations), Root Cause Analysis (RCA), and CAPA.
• Experience with network-based applications such as Veeva.
• Knowledge of current industry trends and ability to use the latest technologies.
• Experience supporting multiple projects/teams within stated objectives and timelines.
• Experience supporting cross-functional team members and collaborate effectively.
• Good communication skills (written and verbal) and the ability to exchange potentially complex information.
• Able to integrates activities with other groups, departments and project teams as needed.
• Demonstrated ability to support evaluation of quality matters and solve straightforward problems using technical experience and judgement based on precedent.
• Ability to work in a fast-paced environment and meet quality, accuracy, and timeliness objectives.
• Expanded conceptual knowledge of cGMP's in a pharmaceutical setting.

Responsibilities

• Delivery of Annual Product Quality Reviews (APQRs) for all commercial products.
• Coordinates with SMEs to develop the scope and author content of APQRs.
• Ensures appropriate CAPA actions are identified.
• Ensures completed reports are approved and archived.
• Assist with executing and developing quarterly product quality trending for commercial products manufactured at Vertex and Contract Manufacturing Organizations.
• Assist with preparation of Quality Management Review materials.
• Identifies and facilitates continuous improvement efforts.
• Helps represent Vertex Quality on cross-functional working teams, applying strong communication and collaboration skills.
• Support continuous improvement projects.

Benefits

• compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior