- Title: Documentation Specialist
- Code: RCI-81988
- Location: Des Plaines Illinois (IL) 60018
- Posted Date: 03/18/2020
- Duration: 8 Months
Talk to our Recruiter
- Name:Sumit Rawat
- 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 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.
- 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.
- 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