Randstad Document Specialist in Northbrook, Illinois

Document Specialist

description

job details:

  • location:Northbrook, IL

  • salary:$28 - $33.78 per hour

  • date posted:Tuesday, July 18, 2017

  • job type:Contract

  • reference:21999

Job Title: Clinical Quality Documentation Specialist

Position Responsibilities

  • Guide and advise authors and SMEs of procedures and other quality documents owned by the Medical & Development organization as they develop documents that drive compliance and global harmonization

  • Assure that quality documents are aligned with the quality document architecture and standards

  • Review multiple documents, and track common and differing elements to aid in harmonizing efforts

  • Perform impact assessment of new, revised or obsoleted quality documents and complete related change request documentation

  • Manage the change control process for new and revised quality document, and ensure appropriate stakeholder review and approval of quality documents

  • Assist with the collection of quality documentation data and related metrics

Position Requirements

  • Bachelor's degree (preferred) with a minimum of two(2) years of experience managing and/or supporting quality document development/revisions in the pharmaceutical or healthcare industry

  • Associates degree with a minimum of five (5) years of experience managing and/or supporting quality document development/revisions in the pharmaceutical or healthcare industry

  • Basic working knowledge of GCP

  • Attention to detail in performing quality data management tasks

  • Experience using Microsoft Office products, including Word, Excel, Visio and PowerPoint

  • Experience with Documentum based systems a plus

  • Strong written and verbal communication skills

  • Ability to work in cross-functional teams

  • Good negotiation skills

  • Excellent organizational skills and the ability to handle multiple priorities and projects

Benefits

  • Medical, Dental, and Vision Insurance

  • 401K Plan with Company Match

  • Life and AD&D Insurance