Training Specialist

Position Summary

We are looking for a Training Specialist who will be responsible in maintaining quality and compliance processes associated with training and development to ensure GMP requirement and the company’s compliance requirements are met.

Duties & Responsibilities

• Design, develop and coordinate training program needs.
• Develop and/or review and maintain site curriculums and training requirements in the Veeva Electronic Learning Management System (EDMS).
• Act as a subject matter expert for the Veeva EDMS and collaborate across functional areas to develop and align the site training requirements.
• Ensure that all training requirements and curriculum is reviewed within required intervals.
• Ensure GMP training documentation is maintained and controlled per company procedures.
• Author procedural documents related to area of responsibility and participate in activities to support regulatory agency inspections.
• Create dashboards and training reports within Veeva.
• Monitor, track, and trend training.
• Act as document control to route procedural documents in the Veeva EDMS to ensure accuracy, completeness, and alignment with procedures.
• Support document control and other quality systems activities as needed.  

Required Qualifications

• A minimum of 4 years’ experience in the pharmaceutical or medical device industries.
• Bachelor or associate level degree in Pharmaceutical Sciences, Biology or related field preferred. High School degree with 6+ years of experience of cGMP production experience may be considered.
• Strong project management, organization, and execution skills with ability to managing multiple projects and priorities.
• Excellent interpersonal and written communication skills and experience using various software/electronic applications required.  

Preferred Qualifications

• Experience with Veeva
• Yellow belt certification