Job Details

  • Title: Documentation Specialist
  • Code: RCI-ABT-79797
  • Location: Lake Forest Illinois (IL) 60045
  • Posted Date: 10/08/2019
  • Duration: 11 Months
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  Job Description

Document Specialist

Summary:

  • This Document Specialist is responsible for authoring and processing change requests supporting the implementation of the new Medical Device Regulations for Invitro Diagnostics (IVD-R).
  • This position will work with the Diagnostics Division QMS IVD-R team to assist with coordination of change packages and documentation for successful completion of assigned projects.
  • Not meeting the schedule requirements may result in delay of implementation of the new regulation.
  • The ideal candidate must be able to problem solve, manage projects, influence internal and external groups and provide guidance to project teams for documentation requirements.
  • Project management skills is also desirable.

Main Responsibilities:

  • 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 procedure
  • Edits and processes documents such operating procedures, forms, training materials, and other related quality system documents
  • Reviews documents for consistency with similar or related documents
  • Must be able to rearrange priorities on short notice to react to (internal) customer needs
  • Must complete documentation of new processes or revisions to existing processes accurately and on-time. Quality of the product is directly linked to the accuracy of the associated documentation.
  • Must be able to problem solve, manage projects, influence internal and external groups and provide leadership to project teams for documentation requirements
  • Must have strong organizational, communication and human relation skills to deal with the functional areas within the division.