Document Specialist

  • location: Sunnyvale, CA
  • type: Contract
  • salary: $31.17 - $36.67 per hour

job description

Document Specialist

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QA Document Control Specialist

Job Summary

Assists in maintaining a compliant, efficient Quality Assurance Document Management program.

Job Responsibilities

  • Under direct supervision, perform day-to-day Document Control activities:

    • Process DCR packages and review for correctness and completeness
    • monitor and update in-process documents
    • create, assign and archive QA controlled lab notebooks and logbooks
    • assist in managing the electronic document management system
    • assist in managing access to Master Documents in the Document Control Vault
    • create reports
  • Performs duties in support of established records management procedures, including scanning, filing and managing offsite records storage and retrieval. Participate in internal audits
  • Assist in updating SOPs
  • Participate in regulatory inspections
  • Provide user assistance with using the Electronic Document Management System
Education & Qualifications

  • High school diploma with 2 years of general document control experience
  • 0-2 years of pharmaceutical experience in a GMP environment.
  • 0-2 years experience using and administering electronic document management tools
  • General knowledge of electronic documentation systems, data retrieval, and electronic file formats
  • Working knowledge of Quality Systems, GMP-related requirements and ICH guidelines, desirable.
  • Willing to learn new areas of responsibility.
  • Detail oriented with solid problem solving acumen.
  • Ability to work effectively in a team environment.
  • Ability to analyze and reconcile moderately complex issues.
  • Must have demonstrated initiative and accountability in a fast paced environment.
  • Excellent verbal and written communication and interpersonal skills.
  • Proficient with computers and word processing software (i.e. Microsoft Office products).

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance
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