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