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

Job Description:

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.

Key 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.

Qualifications:

• 
  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

$55-$62/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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No C2C or Third-Party Vendors