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 at Cook MyoSite will help identify, develop and support the implementation of training programs to ensuring consistency, compliance, and effectiveness within and across all departments.
• Develop, implement, and maintain training within the Quality System
• Implement and maintain training database and records management of all training materials
• Assist in designing and implementing training resulting from audits, Corrective Actions and/or training resulting from identified performance errors
• Adhere to all guidelines pertaining to training established by the Quality Systems
• Assist in designing and maintaining reports to track training compliance and progress
• Assist in working with management to develop and maintain training curricula
• Work strategically with managers to maintain compliance to training curricula and training courses
• Maintain a general awareness of company events and employees’ day-to-day activities to stay on top of company affairs
• 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
• Knowledge of cGMP concepts and guidelines strongly desired
• 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
• Office Setting: 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.