- 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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- Name:Sumit Rawat
- Email: email@example.com
- Phone: 908-704-8843 ✖ 232
- 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.
- 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.