Training Specialist

The Training Specialist is responsible for actively working with Learning Management System in maintaining, monitoring, and updating data along with user support; interfaces with all departments providing support and oversight of training record compliance to ensure GMP standards for training and documentation are adhered to and maintained. The Training Specialist is also responsible for group and individual training sessions, including scheduling, training delivery, materials/media development and record keeping. Assists with Development & Delivery in developing content and formatting training materials. Organizes and presents training sessions to groups or individuals in the areas of regulatory related processes such as SOPs, cGMP, Occupational Health and Safety related issues and to provide support and oversight of training compliance as necessary. Participates in other quality systems activities such as internal audit, inspection preparation and change control as required. Ensure course material, training records and databases are maintained in a cGMP & OSHA compliant manner Review records for accuracy and completeness, filing; ensure training records are kept current and compliant with record retention schedule. Track/monitor training and provide timely, accurate information including metrics to management for actions needed to ensure compliance. Use and maintain the validated Quality Learning Management System (LMS) and ensure the application is used to its full potential: o User set ups, security roles, system setup, system maintenance, application specific evaluation and testing including executing system protocols for upgrades o o Maintain course registration, preparing statistical reports and analysis for metrics to evaluate performance and progress of trainees. Deliver presentations that effectively engage and communicate Develop print material including graphic design D o Education or Equivalent: Bachelor''s Degree or equivalent experience in a learning and development/training/HR related field Experience: 3 - 5 years of experience in training or education FDA or related regulatory work environment experience preferred Knowledge/Skills Requirements: High level of attention to detail Ability to work independently on multiple projects Works well in a team environment Possess and demonstrate excellent verbal, written and interpersonal communications skills Well organized and detail and multi-task oriented Works well under pressure and able to prioritize workloads Review reports, etc. for accuracy and logic Meet deadlines and work under pressure with limited supervision Should be familiar with cGMP and safe work practices Demonstrate initiative; develop ideas, and collect them from others; Demonstrate a bias toward action, get things done; be willing to take a position, and assert influence to drive improvement. Demonstrated ability to read, write, and speak clear English

Created: 2021-11-29