Senior Quality Operations Specialist (Contract) 21976

General Summary:

The Sr. Quality Operations 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 Duties and Responsibilities:

• As part of the GMP Operational Quality group primarily responsible with providing quality oversight and support to Vertex Cell and Gene Therapy operations in the following key areas/activities; support of manufacturing operations across all phases of development and commercial, support of analytical laboratory, materials management, and facility/engineering groups.
• Responsible for batch disposition activities.  Review batch data, including batch records, deviations, in-process data, EM data, QC release testing and other quality systems as applicable to determine acceptability of product disposition.
• Responsible for review and approval of COAs, and product release
• Provide production floor support and provide guidance for GMP product quality and compliance for product release, including resolution of product quality investigations and quality issues of a significant nature, and provides direction for product disposition decisions including shipment.
• Review and approval of manufacturing documents
• Participate in compliance walkthroughs for inspection readiness and help drive the closure of any observations
• Responsible for identifying risks and communicating gaps for GMP process/systems, quality processes optimization for area/equipment release, material disposition, quality systems etc.
• Participate in continuous improvements of department processes
• Communicates proactively with internal and external 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.
• Strong leadership skills with the ability to thrive in a high throughput environment
• Collaboration / Teamwork: Ability to independently lead cross-functional teams and represent the Quality unit
• Communication: Ability to communicate effectively across all organizational levels
• Critical Thinking / Problem Solving: Ability to evaluate quality matters and make decisions utilizing risk-based approach
• Attention to detail

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
• 3+ years experience in field

$43-53/hr

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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If you do not agree with the Atrium Terms and Conditions, you can still complete your application for this position by emailing your resume to our team at tempstaffing@vrtx.com. Please include the job title in the subject of your email.

No C2C or Third-Party Vendors