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Quality, Senior Training Associate

Quality,Senior Training Associate
Position Summary
The primary role of the Sr. Training Associate will be to manage Amicus training needs for the organization, including curriculum development, maintenance, and conduct and/or coordination of training. This role will work to effectively maintain employee curriculums through interaction with Business Partners and to ensure appropriate reporting, notifications and metrics are employed. Additionally, this role will ensure procedures capture the link between training curriculum and job descriptions. All training records (i.e. CV/Resume, JD, classroom records) are archived and retrievable to support compliance activities for the organization.
Roles and Responsibilities
Identifying subject matter experts (SME) to develop training materials
Identifying 'off the shelf' e-learning programs, as needed
Supporting and further developing GxP curriculums
Work with management and business partners to identify and develop training curriculum and identify role changes requiring training support
Developing and executing training procedures ensuring effectiveness of the process
Developing and reporting metrics on training requirements and perform necessary follow up to drive completion to ensure that identified training goals are reached.
Acting as the training module administrator for the Amicus LMS
Providing sub-administrative support
Providing consistent, reliable, and accurate reporting on the state of GxP and non-Gx training activities
Meticulously document all training plans, presentations, and acknowledgements in the relevant training management system
Providing archive and inspection readiness support whenever required.
Performs other projects and duties as assigned.
Requirements
BA or BS in related field
Experience and Skills
3 to 5 years' experience working in a FDA regulated industry (Pharmaceutical, Biotechnology or Devices).
Working knowledge of FDA, ICH and Global regulations and best practices for Training/Learning Management.
Experience in database management, reporting and trending systems.
Previous Master Control, Compliance Wire or Learning Management experience required.
Travel
0-5%



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