Job Title: Training Support Specialist

Location: Scarborough, Maine, 04074

Duration: 06 Months

Shift: Monday – Friday, 8am - 5pm flexible

Min. Pay starts from: $28/hr on W2

Job Description:

Supports the administration of the Learning Management System (LMS) and management for the Quality System Training Program to ensure employees are trained to perform their activities.

• Provides Subject Matter Expertise on the learning process including learning management system 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 a direct and proactive relationship with internal and external customers, has a strong understanding of current customer needs, anticipates and addresses issues, escalating as applicable.
• Authors and reviews learning documentation/material.
• Supports audit readiness to ensure successful audit inspection results related to the Learning system and/or processes.
• Ensures training program meets quality standards.
• Coordinate and support completion of training programs that are required to meet cGMP requirements.
• Maintains applicable administrative procedures and policies to ensure compliance with business process and regulatory expectations.
• Conduct training curriculum reviews and revise training plans accordingly
• Create and assist with the development of training materials.
• Coordinating resources (other presenters/instructors, course materials, training space, etc.),
• Create/manage a qualified train the trainer program

Education:

• BS in preferably in Education, Science Engineering, Human Resources, Business, Instructional Design, or related discipline or equivalent combination of education and experience.
• 2-5 years experience in the medical device or regulated industry preferred.
• Demonstrated proficiency using Microsoft Word, PowerPoint, and Excel

Preferred qualifications:

• Familiar with federal and other regulations, e.g. QSR’s, ISO 13485, CMDR, IVDD/IVDR
• Knowledge of adult learning delivery techniques and general principles of adult learning a plus.
• Ability to think strategically and provide direction to the management team along with the capacity to balance both short term and long term issues effectively.
• Preparing and delivering presentations
• Requires strong written and verbal communication skills.
• Requires strong organizational and time management skills, and the ability to prioritize multiple responsibilities and projects.
• Requires ability to deal appropriately with regulatory agencies.
• Requires working knowledge of training requirements required by regulatory agencies (documentation, effectivity, etc.)
• Must be able to work independently under minimal supervision.
• Must follow standard safety policies and procedures.
• Experience utilizing word processing software (e.g. Microsoft Office - Word, Excel and PowerPoint)