Sr. Quality Assurance Specialist – Operational Quality, External Manufacturing (VCGT) (Contract) 27669

Vertex Pharmaceuticals • Boston, MA

7h • $55 - $62

About The Position

The Operational Area Senior Quality Specialist will provide QA support for manufacturing operations, analytical laboratory operations and materials management for external manufacturing programs at VCGT. This role will review batch data, including batch records, deviations, in-process data, EM data, QC release and stability testing and other quality systems documentation as needed in support of product disposition.

Requirements

• Bachelor’s degree in a scientific or allied health field with 3-5 years of relevant work experience, or relevant comparable background.
• Knowledge of cGMP's in a pharmaceutical setting
• Experience providing QA support and oversight of GMP manufacturing and GMP laboratory operations.
• Experience successfully leading event investigations, deviations and change controls
• Experience with network-based applications such as Veeva, LIMS and Oracle
• Strong attention to detail
• Effective communication skills, both verbal and written

Responsibilities

• Reviews master batch records and provide customer approval for quality tasks for externally manufactured products
• Reviews analytical laboratory testing data including method validation and QC testing with providing customer approval for externally manufactured products.
• Performs final review of executed batch and/or critical systems documentation including certificate of analysis / certificate of conformance and determines acceptability by using standard operating procedure
• Ensures presence and acceptability of all required documentation prior to the release of the product and/or system.
• Reviews and approves investigations, deviations, and change controls for external programs
• Supports the day-to-day management of the batch release process.
• Communicates proactively with internal and external partners and management
• Assists in the maintenance and archival of document management such that documents are readily available and easily retrievable.
• Escalates critical and major findings to Quality management.

What This Job Offers

• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees