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Functions as part of a team to provide documentation and quality management system support to people engaged in the research and development; production of PET biomarkers; and/or corporate support roles.Assists with maintenance of Engineering Change Notice System for product improvements, repairs and new product development. within the Agile PLM System.
Creates and maintains workflows within the Agile PLM system.
Monitors and maintains Agile PLM System.
Coordinates the interaction between engineering, manufacturing, field operations and marketing to ensure all changes are documented for audit purposes (may include FDA, ISO, IEEE).
Guides effective interaction between Engineering and Development and Operations to ensure all changes are documented for audit purposes.
Works cross-functionally with engineering, sales, and PETNET production to successfully implement strategic initiatives.
Incorporates new technology, products and processes into daily operation
Works in compliance with all regulatory standards including EH&S, cGMP, Radiation Safety, applicable pharmacy laws, DOT, and internal policies and interpretations of the above as required.
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