Contract

QMS Specialist

SalaryCompetitive
LocationBoston, Massachusetts, United States
SectorPharmaceuticals & Biotechnology

Description

QMS Specialist (Contract)

SUMMARY

The Quality Management Systems Specialist will provide assistance for the Quality Documentation and GxP Training programs, including preparing for and facilitating the transition to a new electronic training system, day-to-day document processing, and supporting continuous improvement of document and user databases.

PRIMARY RESPONSIBILITIES

  • Create and maintain user accounts in the electronic training system
  • Update and maintain user profiles, groups, and training curricula
  • Issue training assignments to end users
  • Assist with review of GxP documents for completeness, consistency, and formatting
  • Initiate document approval workflows (i.e., support and facilitate reviews, consolidate comments and redlines, track workflows)
  • Work with cross-functional departments to initiate and track document revisions
  • Provide support for electronic training system activities

QUALIFICATIONS

  • BA or AD or equivalent work experience preferred
  • 1-2 years document control or GxP training experience preferred
  • Excellent technical skills required; candidate must be comfortable working in and collaborating with users across multiple computer systems
  • Strong organizational skills, including the ability to execute ongoing multi-step processes
  • Ability to multitask and work efficiently and independently with all levels of the organization
  • Experience using Microsoft Office applications required
  • Experience with Adobe Acrobat Pro, Excel, and Microsoft Visio a plus
  • Veeva Vault experience a plus
  • Exposure to GxP regulations a plus

 

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