GMP training manager

4/26/21

Lexington, KY 40511

1218

FullTimeRegular

The GMP Technical Trainer is responsible for the development and implementation of cGMP training programs for manufacturing employees.
Works in conjunction with manufacturing leadership to identify needs and ensure that team members’ skill levels appropriately meet business needs.
  • Conduct training needs analysis to identify knowledge and/or procedural gaps within the manufacturing process
  • Create and oversee on-the-job training criteria through the development of train-the-trainer programs
  • Routinely deliver various cGMP training sessions for new and existing employees, focusing on specific SOPs, equipment, change controls, documentation, and health and safety-related topics
  • Manage and maintain training content and records in accordance with internal and external regulations
  • In conjunction with HR and EHS, ensure the effectiveness of new hire onboarding activities
  • Implement a formalized skill matrix to promote growth and development
  • Issues reports on the status of training initiatives
  • Track new hire training progress and ensure completion
  • Evaluate the effectiveness of all training initiatives and implement changes as necessary
  • Ensure quality and safety guidelines are included appropriately within training content
  • Provide support in regulatory and customer audits related to training documentation
  • Contribute to the development and reviewing of SOPs, Technical Manuals and safety procedures
  • Bachelor’s degree in a scientific discipline, or equivalent 5+ years GMP training experience in the pharmaceutical industry
  • 5-7 years experience in a biotech/pharmaceutical, GMP, or FDA regulated environment, preferably in a training or leadership capacity
  • Experience in training to those who may not be familiar with cGMP concepts
  • Experience with the preparation and delivery of training materials
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