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Quality - Global Product Quality Specialist 

resume-library  |  United States  |  

United StatesUnited States (US)
Tv & Film Production/Production
Work Type:
Work Time:
Full Time


Quality - Global Product Quality Specialist

Job Description: Global Product Quality Specialist

The Global Product Quality Specialist will be responsible for managing (and owning as needed) documentation and change controls associated with key deliverables to clinical and commercial documentation across multiple programs. Functional responsibilities include tracking of multiple work streams and collaborate across multiple functions (i.e. Site QA/QC, manufacturing, validation, IT, manufacturing science and technology, analytical development, etc.) to ensure all technical and compliance requirements are met per clinical and commercial development timelines.

" Support Change control, Deviation and CAPA management, and author and/or review GxP documents as required.

" Support the revision and/or review of Specifications, Protocols, Annual Product Quality Review (APQR) templates and documents as required.

" Support GxP document management in electronic documentation systems (e.g., Veeva etc.).

" Provide assistance to other Global Product Quality staff members as needed. Performs other QA duties as assigned.

Basic Qualifications:

" Minimum of 3 plus years working under GMP conditions. BA or BS degree.

" Strong written, verbal, and organizational skills, and ability to work in inter-disciplinary and cross-functional teams.

" Experience with Infinity, eQRMS, electronic documentation systems (Veeva), and other quality systems is preferred.

" Experience with owning change controls is required.

" Scientific background with basic understanding of analytical methods, stability, specifications and Quality Control

" Understanding of FDA, EMA, ICH, USP, and EP guidelines and regulations associated with the quality control of biological products.

" Detail oriented with high degree of focus. Able to follow instructions and procedures, both written and verbal.

" Able to understand complex work practices.

" Ability to work in a high paced team environment, meet deadlines, and prioritize work from multiple projects.

" Able to perform with minimal supervision and contribute in a team environment.

" Basic knowledge and ability in using Microsoft Office Package.

Additional Job Requirements: