Cook MyoSite, Inc. is on a mission to make regenerative medicine a part of everyday medicine. We’re investigating our core technology, autologous muscle-derived cells, for the potential treatment of several muscle-related disorders. We at Cook MyoSite have the potential to make a difference in the lives of countless people around the world, and we also have the potential to make a difference in yours. Joining our team is an opportunity to ignite your passion, grow your potential, and define your purpose. If you’re curious, motivated by helping others, and driven by integrity, we invite you to apply.
The Training Specialist I at Cook MyoSite, Inc. helps identify, develop, and support the implementation of training programs to ensure consistency, compliance, and effectiveness within and across all departments.
• Adhere to all guidelines related to training as established by regulatory authorities and company systems
• Develop, implement, and maintain training within the company
• Maintain training database and records management of all training materials
• Responsible for the development and delivery of applicable training sessions (OJTs, CAPA trainings, etc.), as warranted
• Ensure that trainings are relevant to the affected roles by assisting department with Job Code architecture
• Provide guidance to leadership regarding job codes
• Communicate incongruences in training to departmental management and provide recommendations for rectification
• Assist Departmental Trainers in scheduling and completing OJT tasks
• Review and complete all associated training forms/paperwork following GDP guidelines
• Maintain an open line of communication with the Training Department; attend inter-departmental meetings as needed
• Collaborate with and provide guidance to department Subject Matter Experts (SMEs) to develop/maintain position Training Plans
• Maintain Designated Trainer status
• Act as liaison for new hires
• Assist in conducting recurring GxP trainings
• Provide guidance on the development of training materials.
• Review training material as needed
• Assists in identifying/creating/developing/implementing/reviewing training based on audits, CAPAs, gaps, discussions
• Audit Learning Management System to ensure compliance with SOPs.
• Undergraduate degree in any field or 6 years direct, relevant experience in a training or quality environment to provide a comparable background
• Minimum of 1-3 years' experience in training atmosphere within Pharmaceutical/Biopharmaceutical or manufacturing is preferred
• Knowledge of cGMP concepts and guidelines is preferred
• Proficient knowledge of Microsoft Office software, and other general office equipment.
• Basic understanding of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical product manufacturing
• Ability to work in collaborative and independent work situations and environments with minimal supervision
• Maintain composure and competence under stressful situations; demonstrate flexibility and adaptability
• Must work and interact effectively and professionally with and for others throughout various levels of the global organization to achieve company goals
• Office Setting (no travel): This is a Hybrid position | General office, warehouse, and laboratory setting
• Ability to conduct and hear ordinary conversation and telephone communication.
• Must be able to work extended hours beyond normal work schedule to include, but not limited to, evenings, weekends, extended work hours and/or extra work hours, sometimes on short notice as required.
• Ability to work under specific time constraints.
• Must be able to sit at desk, in meetings and/or work on a computer for long or extended periods of time.
• Visual and manual acuity for working with computers and equipment.
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