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.

This position reports directly to the Director of GMP Operational Quality, Compliance and Technical Operations

Key Responsibilities:

The responsibilities of this position may include, but are not limited to, the following:

• 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.

Minimum qualifications:

Education and Experience:

• 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

Pay Range

$55-$65/hr

Requisition Disclaimer

This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals ("Vertex"). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements

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