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Documentation Specialist I

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Position Role/Tile: Documentation Specialist I

The Document Specialist will prepare and route for approval project-related documentation.
This will involve managing many incoming documents and adhering to tight schedules.
The Document Specialist will report into Document Control and work closely with Design Quality Assurance, Project Management and Development teams.
Medical Device and/or Pharmaceutical experience is highly desirable

Skills Essential Functions:
Under general supervison, prepares and routes for approval product-related deliverables per the RUO Product Development Process and approval matrix. Deliverables will include requirements documents, protocols, plans, reports, etc. Reviews submitted documents to verify references, grammar and formatting. Verifies proper templates and revisions were used. Ensures document alignment with templates. Works with document authors to correct issues.
Manages project workspaces and workflows within the EDMS system.
Manages the approval process to ensure the timely release of documentation.
Provides assistance to document authors to aid in formatting of documents, e.g. pagination, headings, image placement, section numbering, etc.
Works closely with Design Quality Assurance, Development and Project Management teams to ensure documents are approved in a timely manner.

Essential Knowledge and Skills:
Must be able to manage and meet multiple project deliverables and deadlines.
Ability to work independently and have proven time management skills.
Excellent English, spelling, and grammar skills.
Able to adapt to a fast-paced, changing environment.
Must be able to work well with all levels of associates, from entry level to management.
Must be well organized, thorough, and detailed oriented.
Must be able to review and edit content to ensure accuracy and proper formatting.
Keywords Education Must possess a combination of education and experience as follows:
Minimum Associate's degree in Biological Sciences, Chemistry, or related field
2+ years or relevant experience in the diagnostics or pharmaceutical industry focusing on controlled documentation
Proficient with Microsoft Office (Word, Excel, PowerPoint and Visio)
Knowledge of Electronic Document Management System (EDMS) a plus (i.e. DiaDoc, Documentum, Agile, Arena, etc.)
SAP experience a plus.

Central Business Solutions, Inc,
37600 Central Ct.
Suite #214
Newark, CA 94560.
Central Business Solutions, Inc(A Certified Minority Owned Organization)
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Central Business Solutions, Inc
37600 Central Court Suite 214 Newark CA, 94560
Phone: (833)247-8800 Fax: (510)-740-3677

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