Associate Scientist- Quality Control - JUNO ONLY

Posted 6 days 3 hours ago by Ascent Services Group

Permanent
Not Specified
Science & Technology
Washington, Seattle, United States, 98109
Job Description
Associate Scientist- Quality Control
Seattle, WA

The Global Product Quality Specialist, Critical Reagent / Raw Materials / Tech. Transfer Coordinator will be responsible for planning and overseeing critical reagent and critical raw materials in support of global method transfer activities across global product quality. More specifically they will be managing key deliverables associated with clinical and commercial critical reagent / raw material needs across multiple programs. This may include inventory management, key stakeholder collaboration, strategic planning, and coordination between multiple sites and functions. We are looking for someone who can 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 as needed. Performs other QA duties as assigned.

Basic Qualifications:
  • Minimum of 5-7 years of demonstrated success as a leader of complex business or technology initiatives. BA or BS degree.
  • Detail oriented with high degree of focus. Able to follow instructions and procedures, both written and verbal.
  • 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.
  • Scientific background with basic understanding of typical analytical methods and Quality Control
  • Able to perform with minimal supervision and contribute in a team environment.
  • Experience with eQRMS, electronic documentation systems (Veeva), and other quality systems.
  • Basic knowledge and ability in using Microsoft Office Package.
  • Understanding of FDA, EMA, ICH, USP, and EP guidelines and regulations associated with the quality control of biological products.


Job Requirements:
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