Position Summary

The position of Quality Training Compliance Specialist is within our Infectious Disease business unit (BU) supporting sites globally. This role provides training support and expertise to employees to ensure continued compliance with Quality System and administration of the BU Learning Management System. The Quality Training Compliance Specialist is responsible for the maintenance of the Learning Management System, training reporting, and records.

This job description will be reviewed periodically and is subject to change by management.

2. Essential Duties and Responsibilities
Carries out duties in compliance with established business policies and procedures.
Demonstrates commitment to the development, implementation and effectiveness of applicable Quality Processes as per ISO, FDA, and other regulatory agencies.
Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
Responsibility to understand and maintain awareness of the quality consequences which may occur from the improper performance of their specific job.
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.),
Perform other duties and projects as assigned

3. Basic Qualifications – Education / Experience / Skills
BS in preferably in Education, Science, Engineering, or a related discipline, or equivalent combination of education and experience.
Experience in Quality Management Systems preferred.
Experience utilizing word processing software (e.g. Microsoft Office - Word, Excel and PowerPoint)