Job Details

  • Title: Documentation Specialist
  • Code: RCI-81988
  • Location: Des Plaines Illinois (IL) 60018
  • Posted Date: 03/18/2020
  • Duration: 8 Months
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  Job Description

Document Specialist

Summary

  • The ideal candidate must be able to problem solve, manage projects, influence internal and external groups and provide of assigned projects
  • Not meeting the schedule requirements may result in delay of implementation of the new the new Medical Device Regulations for Invitro Diagnostics (IVD-R).
  • This Document Specialist is responsible for authoring and processing change requests supporting the implementation of Division QMS IVD-R team to assist with coordination of change packages and documentation for successful completion regulation.
  • Guidance to project teams for documentation requirements. Project management skills is also desirable.
Main Responsibilities:
  • Must have strong organizational, communication and human relation skills to deal with the functional areas
  • Must be able to problem solve, manage projects, influence internal and external groups and provide leadership
  • Must complete documentation of new processes or revisions to existing processes accurately and on-time.
  • Reviews documents for consistency with similar or related documents
  • Edits and processes documents such operating procedures, forms, training materials, and other related quality
  • Ensures that any changes made to existing documents are appropriate, justified, and as with new documents are approved by the required functional areas according to established procedures system documents
  • Must be able to rearrange priorities on short notice to react to (internal) customer needs.
  • Quality of the product is directly linked to the accuracy of the associated documentation to project teams for documentation requirementswithin the division.
Description
  • Provide high level of attention to details 
  • Review, approve and route change request in electronic system
  • Review, approve and process change orders in electronic system Support internal/external audits in compliance with FDA and ISO practices and procedures  
  • Multi task across several projects while maintaining strict adherence to project schedules and budget constraints