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Document Specialist
Ref No.: 18-31488
Location: Branchburg, New Jersey
Position Type:Contract
Skill Type
Skill Type:Professional
The Document Specialist performs daily activities according to approved procedures, templates and standards.
Primary activities include editing of Master Documents using MS Word, updating document properties (metadata), tracking of document status, managing of version control, format conversion, distribution, and archiving within the EDMS (Electronic Document Management System).
In addition, the Document Specialist:
Communicates with Change Management sponsors and document authors to ensure proper implementation of change requests.
Monitors implementation of Master documents associated with New Product Launches and Change Requests.
Maintains document templates, project tracking logs, and databases.
Proofreads documentation and reviews for compliance to templates and formatting standards.
Provides technical or procedural guidance to staff on use of templates and database systems used for documentation.
Assesses Master Document distribution activities and adherence to procedure.
Participates in the archival and storage of Master Documents according to the Master Document Retention schedule

Candidate must be proficient in MS Word, Excel, and Visio.
Candidate should possess strong analytical skills, project management skills, focus and attention to detail and must be a strong team player.
Candidate should have:
Experience with managing documents in an EDMS in a Medical Device or Pharmaceutical environment.
Experience working on multi-site, inter departmental projects
Knowledge of the 820 CFR/ISO 13485 as it pertains to Document Controls
Bonus to have Experience with Electronic Batch Records (MES).