HireLevel is looking for a Senior Documentation Specialist in Lake Forest, IL!
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
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.
Job Title: Senior Documentation Specialist
Job Category: Full-time, Long-Term Contract
Shift: Monday - Friday; 8:00 am - 5 pm
Pay Rate: $25+ per hour based on experience
Location: Lake Forest, IL
Similar Positions: Documentation, Office, Record Keeping, Administrative Assistant
Responsibilities of Senior Documentation Specialist:
- 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.
- 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.
Requirements of Senior Documentation Specialist:
- High school diploma or equivalent require, Bachelor’s Degree preferred.
- 3-5 years of related experience required.
- Individual must be able to use multiple software databases concurrently (e.g. ALMS, APLM, DMS, ePAS, GS1, Lotus Notes, SBM, Microsoft: Word, Excel) to work within a document management system, verify multiple sources of information and electronically route completed documents for approval.
- Microsoft Office (Word, Excel) proficiency is required.
- Prior experience working in healthcare/medical device manufacturing environment is beneficial.
- Ability to pass client's background and drug screening requirements.
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