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QA Document Control Specialist

Quality Assurance | Philadelphia, PA | Full Time, Contract, and Temporary | From $30.00 to $40.00 per hour

Job Description

QA Document Control Specialist ROCGJP00039433

  • Hourly pay: $30-$40
  • Worksite: Leading biotechnology company (Philadelphia, PA 19104 - Onsite)
  • W2 Employment, Group Medical, Dental, Vision, Life, Retirement Savings Program, PSL
  • 40 hours/week, 10 Month Assignment

A leading biotech company is looking for a QA Document Control Specialist. The candidate will work to develop, deploy, and support the Veeva Quality Document System, manages, and tracks all GMP documentation.

QA Document Control Specialist Responsibilities:

  • Manage and maintain controlled documents in Electronic Document Management System (EDMS) ensuring documents go through controlled documents life cycle in accordance established procedures.
  • Coordinate the review, finalization, and archival of Spark policies, procedures, and other controlled
    documents.
  • Manage EasyVista (EV) on all incidents and requests for the EDMS and close all tickets in a timely manner.
  • Serve as an administrator of the EDMS including user account management, system configuration, troubleshooting and work with EDMS vendor(s).

QA Document Control Specialist Qualifications:

  • 2-5 years of experience in working with documentation in a regulated industry.
  • BS/BA in Biology, Chemistry, Engineering, related science discipline.
  • Computer literacy required; advanced Microsoft Office skills (Outlook, Word, Excel, PowerPoint)
  • Knowledge of GMP concepts and guidelines.
  • Experience with document control activities.
  • Experience with document control systems.
  • Effective knowledge of maintaining a document and data control system.
  • A general understanding of FDA regulatory requirements as they relate to documentation.
  • Extensive MS Word processing and formatting experience.
  • Experience in automating processes utilizing MS Office products.

Shift:

  • May require occasional shift work, including weekends, off-hours, and holidays as needed.

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