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Global Product Quality Specialist

Job Post Index 23461E-Sy##
Location Summit, NJ
Description: Description
  • Responsible for planning and leading change control implementation for multiple projects across global product quality.
  • More specifically they will be managing (and owning as needed) documentation and change controls associated with key deliverables to clinical and commercial documentation across multiple programs.
  • Provide quality oversight and keep track 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.
  • Follows-up to verify completion of activities.
  • Provides assistance to other Global Product Quality staff members
Skills: Qualifications
  • BA or BS degree.
  • Minimum of 5-7 years of demonstrated success implementing complex business or technology initiatives.
  • Minimum of 3 years working under GMP conditions..
  • Experience with owning change controls is required.
  • Scientific background with basic understanding of typical analytical methods 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.
  • Strong written, verbal, and organizational skills, and ability to work in inter-disciplinary and cross-functional teams.
  • Able to perform with minimal supervision and contribute in a team environment.
  • Basic knowledge and ability in using Microsoft Office Package.
  • Experience with eQRMS, electronic documentation systems (Veeva), and other quality systems is preferred

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