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Documentation Associate

Oakland-Fremont-Pleasanton Metro Area, CA

Posted: 02/12/2019 Job Number: JN -022019-23678

This position supports the Development Documentation group, Service Engineers and Application Specialists within the Global Development department. This position will provide documentation and logistics support for a variety of activities, including but not limited to:

  • Scan and file hardcopy records of the log sheets for lab cleaning and instrument/Bio-safety cabinets.
  • Assist with metadata review and workflow initiation in an electronic documentation management system.
  • Manage highly confidential documents in hardcopy format.
  • Management of the hardcopy DHF documents in the cabinets and coordinate off-site storage/retrieval.
  • Assist with Development employee training management activities weekly gap report generation, training roster processing, assignment of training requirements to new employees, etc.
  • Manage information posted on group collaboration sites.
  • Coordinate IQ/OQ documentation activities: request document number, assemble document for execution, route for post-execution approval signatures, scan and post approved documents, ship approved documents to records management.
  • Support Instrument Management database for service activities: create general requests and work orders for execution in RAM (regulatory assets management tool) software tool, record service activities in team dashboard, and track activities to completion by following up with the service engineers.
  • Support instrument service activities in TrackWise (business-process management tool): transfer information from new RAM work orders into TrackWise tickets
  • High Proficiency w/MS Office required: Word, Excel, PowerPoint
  • High aptitude to learn and use other software tools and/or familiarity with:
    • MS SharePoint
    • SAP
    • TrackWise

Minimum: 1-2 years of experience working in a GMP/ISO regulated environment

Other Qualifications:

  • Demonstrated proficiency to learn new skills and software
  • Meticulous attention to detail to accurately document activities in validated software tools
  • Strong organizational, multi-tasking, and time management skills
  • Ability to be flexible with changing work priorities and follow procedures/supervisor instructions with a cooperative, can-do attitude
  • Strong work ethic and excellent communication skills
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