We are always looking for talented individuals to join our Quality team. Specific openings in Quality come about often. This is an evergreen role, meaning we are always accepting applications to build a pipeline of qualified candidates for future opportunities This is an ongoing opportunity for a Learning Quality, Standards Training and Improvement Specialist/Senior Specialist to join our team, if interested in opportunities, please apply. The Quality Specialist works 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. Candidate must have experience training in a GxP/pharma environment

  • Acts as SME (Subject Matter Experts) for GxP (Good x Practices) Training process and provide ongoing support, tool, and consulting to enable execution of the process
  • Supports GxP regulated employees’ adherence to GxP training program requirements
  • Provides guidance on general training issues of varying complexity
  • Participates in project teams that require training guidance
  • Assists in development of process changes and training materials
  • Liaises with functional Training Coordinators to align quality training initiatives
  • Maintains job aids and tools
  • Manages training materials within electronic document management system
  • Aids in the generation of KPI (Key Performance Indicators) to determine the effectiveness of the training program
  • Aids in review and analysis of training program metrics
  • Functions as a system business administrator for the LMS
  • Supports LMS validation
  • Creates and processes training forms
  • Scans and uploads training documentation
  • Provides customer support (troubleshooting, answering questions, addressing incident tickets)
  • Maintains learning objects, user groups, curricula, and learning assignments within LMS
  • Executes training ServiceNow requests for the following - Process Change Requests (PCR)
  • Collaborates with business partners to conduct Learning Needs Assessment and curricula assignment with business needs - GxP Training Requests
  • Resolves training assignment ticket requests submitted by learning community - Role-based Catalog Maintenance Review and update training catalogs for role-based training
  • Provides reports to evidence GxP personnel training qualifications, as needed
  • Bachelor’s degree and 3 – 5 years of relevant work experience, or relevant comparable background
  • Experience with Learning Management Systems (LMS)
  • Proficient in Zoom and the Microsoft Office suite of products
  • Candidate must have experience training in a GxP/pharma environment
  • Experience with Cornerstone OnDemand LMS
  • Strong problem-solving skills
  • Learning analytics and data analysis techniques
  • Professional verbal and written communication
  • Experience and ability to work easily and effectively with a wide range of people, demonstrating high emotional intelligence
  • Highly developed interpersonal and people management skills
  • Manage multiple projects concurrently with aggressive deadlines
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