Position Overview
Description
Specialist – Document Control. have a cross-functional project that involves over 300 documents. This contractor will: Actively manage/lead the project and provide status updates to leadership Work with document owners to complete periodic review evaluation of their documents and ensure they enter the periodic review verdict in the record. If document update is needed, route documents in the Document Management System (we use Veeva so experience with that platform is preferred) REQUIRED COMPETENCIES (KNOWLEDGE, SKILLS AND EXPERIENCE) Bachelor’s Degree in a life sciences or engineering discipline with a minimum of 5 years of experience in a GMP regulated Biologics or Pharmaceutical environment. In-depth knowledge and understanding of Quality Management System regulations and requirements, global quality standards and cGMPs relating to documentation, training and electronic systems, including electronic records and signatures. Strong authorship and ability to communic...