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Quality Specialist, Quality Standards, Training and Improvement
Boston, MA  Posted: 1/13/2020


Title/Role: Quality Specialist, Quality Standards, Training and Improvement           Area:  Quality Assurance
General position summary:

The Quality Specialist will work cross-functionally to support the training needs of business partners.  This training support includes the administration of the electronic learning management system, maintenance of the training catalog and development of training materials.  The Quality Specialist works with a high degree of independence and is adept at troubleshooting problems to create and execute improved internal procedures, and to ensure compliance with applicable regulatory requirements. This position reports to the Director of Quality Standards, Training and Improvement.

Key Responsibilities:
  • Functions as a system business administrator for the electronic Learning Management System (eLMS)
  • Collaborates with internal customers to design and develop custom training courses requested to support company initiatives
  • Ensures GxP regulated employees adhere to GxP training program requirements
  • Provides guidance on general training issues of minimal complexity
  • Participates in project teams that require training guidance
  • Provides instructor-led training on various GxP topics
  • Develops GxP controlled document training courses as needed
  • Develops and provides training on use of electronic systems
  • Observable knowledge of the following:
    • Applicable regulations and industry trends
    • Adult learning principles
    • e-Learning concepts and software
    • Provides audit/inspection support as needed
The responsibilities of this position may include, but are not limited to, the following:
  • As a system business administrator of the LMS responsible for the following:
    • Execute training tasks
      • Create and process training forms
      • Scan and upload training documentation
      • Provide biennial review oversight
      • Update document trackers with training information
      • Provide customer support (troubleshooting, answering questions, addressing incident tickets)
  • Provide training administration support:
    • Maintain job aids and tools
    • Generate metrics
    • Serve as member of project teams
    • Support electronic system validation
  • LO, Group, Curricula and Learning Assignment maintenance
  • Manage training materials within electronic document management system
  • Review, update training catalogs for role-based training
  • Collaborate with business partners to ensure alignment with business needs
Minimum qualifications:
  • Demonstrated ability to work independently and manage multiple projects that require collaboration across functional areas
  • Ability to work and coordinate cross-functionally
  • Experience with an eLMS (Cornerstone OnDemand experience a plus)
  • Experience with and ability to use Microsoft Office and associated tools (Word, Excel, PowerPoint)
  • Bachelor’s degree and 3 – 5 years of relevant work experience, or relevant comparable background
Preferred Qualifications:
  • Experience with Cornerstone OnDemand
  • Experience in Instructional Design / ADDIE
  • Experience with e-learning software (Articulate Storyline, Adobe Captivate)
  • GxP knowledge with understanding of global regulations
  • Ability to design, develop and deliver effective training; understands and adapts to varying learning styles

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