Quality Assurance Specialist - Analytical Data Review (Contract) 25946

Job Description

This QA position will work with internal and external QA teams and QC labs ensuring adherence to compliance while supporting both clinical and commercial release and stability testing of a genetically edited cell therapy product.  The position will provide compliance support to both clinical and commercial data review and data management.  This person will support QA activities related to GMP release and stability as well as lifecycle improvement for methods related to raw material, in-process, and drug product samples. The GMP-facing nature of this work requires keen attention to detail and understanding of analytical compliance expectations.  

This position is a hybrid position based in Boston that requires the ability to work independently while actively communicating key risks to management.

The Key Responsibilities are as follows:

• Support the lead point of contact for QA activities occurring at multiple contract manufacturing and test organizations, including release & stability testing, method equipment/software validation, and adherence to project timelines.
• Support QA operations for a gene edited hemoglobinopathy cell therapy product and helps troubleshoot technical aspects of analytical methods related to the release of biologics and cell therapy products.
• Authors and reviews data, SOPs, COAs, analytical methods, protocols, and reports.
• Ensures all external laboratory records adhere to cGMP/GDP expectations.
• Supports compliance related teams working towards the goal of continuous improvement.
• Assists with OOS/OOT investigations/deviations and to identify corrective actions to prevent reoccurrence

Pay Range

$45-$55/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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No C2C or Third-Party Vendors