Training Specialist
GForce Life Sciences, Scarborough, ME, United States
Supports the administration of the Learning Management System (LMS) and management of the Quality System Training Program to ensure employees are trained to perform their activities
Provides subject matter expertise on the learning process, including the LMS, to other functional areas
Ensures effective communication, monitoring, and promotion of learning activities
Liaises with division, managers, and team leaders to continuously improve learning processes and/or systems
Establishes and maintains relationships with internal and external stakeholders, anticipates needs, and escalates issues as applicable
Authors and reviews learning documentation and materials
Supports audit readiness related to learning systems and processes
Ensures training programs meet quality standards
Coordinates and supports completion of training programs required to meet cGMP requirements
Maintains administrative procedures and policies to ensure compliance with business processes and regulatory expectations
Conducts training curriculum reviews and revises training plans as needed
Creates and assists in the development of training materials
Coordinates training resources including instructors, materials, and training space
Creates and manages a train-the-trainer program
Qualifications:
Bachelor’s degree in Education, Science, Engineering, Human Resources, Business, Instructional Design, or related discipline, or equivalent combination of education and experience
2–5 years of experience in a medical device or regulated industry preferred
Proficiency with Microsoft Word, Excel, and PowerPoint
Familiarity with applicable regulations (e.g., QSR, ISO 13485, CMDR, IVDD/IVDR) preferred
Knowledge of adult learning principles and delivery techniques preferred
Strong written and verbal communication skills
Strong organizational and time management skills with the ability to prioritize multiple responsibilities
Ability to prepare and deliver presentations
Ability to think strategically and provide direction while balancing short- and long-term priorities
Ability to interact appropriately with regulatory agencies
Working knowledge of regulatory training requirements (e.g., documentation, effectiveness)
Ability to work independently with minimal supervision
Adherence to standard safety policies and procedures
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Provides subject matter expertise on the learning process, including the LMS, to other functional areas
Ensures effective communication, monitoring, and promotion of learning activities
Liaises with division, managers, and team leaders to continuously improve learning processes and/or systems
Establishes and maintains relationships with internal and external stakeholders, anticipates needs, and escalates issues as applicable
Authors and reviews learning documentation and materials
Supports audit readiness related to learning systems and processes
Ensures training programs meet quality standards
Coordinates and supports completion of training programs required to meet cGMP requirements
Maintains administrative procedures and policies to ensure compliance with business processes and regulatory expectations
Conducts training curriculum reviews and revises training plans as needed
Creates and assists in the development of training materials
Coordinates training resources including instructors, materials, and training space
Creates and manages a train-the-trainer program
Qualifications:
Bachelor’s degree in Education, Science, Engineering, Human Resources, Business, Instructional Design, or related discipline, or equivalent combination of education and experience
2–5 years of experience in a medical device or regulated industry preferred
Proficiency with Microsoft Word, Excel, and PowerPoint
Familiarity with applicable regulations (e.g., QSR, ISO 13485, CMDR, IVDD/IVDR) preferred
Knowledge of adult learning principles and delivery techniques preferred
Strong written and verbal communication skills
Strong organizational and time management skills with the ability to prioritize multiple responsibilities
Ability to prepare and deliver presentations
Ability to think strategically and provide direction while balancing short- and long-term priorities
Ability to interact appropriately with regulatory agencies
Working knowledge of regulatory training requirements (e.g., documentation, effectiveness)
Ability to work independently with minimal supervision
Adherence to standard safety policies and procedures
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