Training Compliance Specialist

4 weeks ago

Scarborough, Maine, United States Blue Star Partners, LLC Full time

Job Title: Training Support Specialist

Job Summary:

We are seeking a highly skilled Training Support Specialist to join our team at Blue Star Partners, LLC. The successful candidate will be responsible for providing training support and expertise to employees to ensure continued compliance with Quality System and administration of the divisional Learning Management System.

Key Responsibilities:

  • Support 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.
  • Provide Subject Matter Expertise on the learning process including learning management system to other functional areas.
  • Ensure effective communication, monitoring and promotion of learning activities.
  • Liaise with Division, Managers and Team Leaders to continuously improve learning processes and/or systems.
  • Establish and maintain 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.
  • Support 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

Requirements:

  • 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
  • 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)

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