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We are hiring a Clinical Documentation Specialist near San Jose, CA!

San Jose Metro Area, CA

Post Date: 05/17/2018 Job ID: JN -052018-21612 Job Type: Clinical

  • Perform daily activities related to the document and record management process, document support for development, and training system.
  • Provides superb customer support while ensuring compliance to regulatory requirements and internal policies and procedures.
  • Secures and controls legacy development files and obsolete files to maintain traceability and prevent misuse.
  • Ensures obsolete revisions are removed from points of use.
  • Provides guidance to document initiators in document formatting according to approved procedures, templates and standards, such as routing, tracking of document status, approval notification, version control.
  • Formats documents according to templates.
  • Ensures complete Change Requests, monitor approval.
  • Collaborates with supervisors to assign training requirements for new employees. Enters group training records in training system. Runs proactive training gap reports.
  • Supports Development in creation, maintenance and design transfer of BOMs, part specifications, and manufacturing drawings and instructions to Production.
  • Ensures quality records and reports are reviewed, organized, scanned and filed. Retains and manages records according to company record retention requirements.
  • Supports internal and external audits.
  • Provides documents and data records in a timely fashion.
  • Participates in audit preparation, meetings, and responds to questions related to job function. Manages requests in audit ready room.
  • Maintains office supplies for Quality department.

  • AA or Bachelor s Degree, or high school degree with equivalent experience.
  • 3-5 years related experience in quality records management in a cGMP environment.
  • Excellent organization and attention to detail.
  • Excellent verbal and written communication including spelling, grammar and editing skills.
  • Strong interpersonal skills, ability to work independently and in teams.
  • Microsoft Word expertise with a solid understanding of the review and formatting tools required.
  • Visio, Excel, and PowerPoint competencies.
  • EDMS electronic document management system and/or LIMS experience.

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