- Title: Documentation Specialist
- Code: RCI-ABT-78294
- Location: Lake Forest Illinois (IL) 60045
- Posted Date: 07/11/2019
- Duration: 12 Months
- Status: Open
- Email: email@example.com
- Phone: 908-704-8843 ✖ 232
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
- 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
- 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)
- Not meeting the schedule requirements may result in delay of implementation of the new regulation
- Must be able to problem solve, manage projects, influence internal and external groups and provide leadership to project teams for documentation requirements
- Reviews documents for consistency with similar or related documents
- 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.
- Edits and processes documents such operating procedures, forms, training materials, and other related quality system documents
- Must be able to rearrange priorities on short notice to react to (internal) customer needs.
- 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
- Must have strong organizational, communication and human relation skills to deal with the functional areas within the division.