Document Control Database Administrator - Mountain View

Mountain View  ‐ Onsite
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Keywords

Description

TITLE: Document Control and Database Administrator

DEPARTMENT: Quality Assurance

REPORTS TO: Director of Quality

EDUCATION/EXPERIENCE:

BA Degree / AA Degree or equivalent. Experienced in Document Control and Database management preferably in the medical device industry.

SUMMARY:

Responsible for creating, maintaining and improving the sites electronic Access databases; development, implementation and maintenance of Quality Management Software; and Document Control activities such as part number and order number assignments, revision control of documents/drawings, processing change orders, data entry and coordination in electronic databases, and paper documentation.

NECESSARY SKILLS:
  • Experienced in Good Documentation Practices
  • Advanced user knowledge of Microsoft Office, Access, Excel, Project, Visio, and Word
  • Proficient in Formatting, Drawing, Forms, Frames, Tables, Borders, Numbering, Inserting and Bookmarks.
  • Proficient in creating and modifying macros and advanced formulations between workbooks
  • Advanced programming in Microsoft Access
  • Experienced in implementation and maintenance of electronic document control databases
  • Experienced user of ERP software
  • Strong technical writing and oral communication skills
  • Self-motivated


  • ESSENTIAL FUNCTIONS:Support all requirements and/or functions of the Document Control Department
  • Responsible for all Document Control duties
  • Responsible for all electronic databases
  • Review incoming change requests for accuracy and completeness
  • Assign Part/Document Numbers and Document Change Order (DCO) Numbers; maintain a database of all numbers
  • Process DCO's, ensure all approval requirements are met, and compile required changes to documents.
  • Make recommendations to management about document control work flow for most efficient implementation of DCOs, including ensuring compliance with ISO and FDA requirements.
  • Maintain all controlled documents in a secure area
  • Ensure accuracy and integrity of data maintained in the document control database
  • Prioritize tasks as required to maintain a smooth and timely flow of Document Change Orders
  • Coordinate interaction between stakeholders to resolve discrepancies and ensure appropriate changes are documented.
  • File and distribute document copies in paper and electronic format
  • Create and change department procedures and documentation
  • Requisition supplies and materials
  • May be required to assist in other departments and/or perform other duties as assigned


  • ADDITIONAL NECESSITIES:
  • Provide a high level of service to internal customers, ensuring that documentation management occurs in a timely and thorough manner
  • Demonstrate a positive and professional demeanor throughout Quality Assurance and all departments
  • Understanding of 21 CFR 820, ISO 13485, MHLW Ministerial Ordinance 169 and the IVD Directive


  • To find out more about Real please visit www.realstaffing.com
    Start date
    12/2013
    Duration
    6 month to hire
    From
    Real Staffing
    Published at
    10.12.2013
    Project ID:
    638624
    Contract type
    Freelance
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