Contract position: A leading biomedical organization located in Rockville, MD is looking for a Training Specialist. This is a 9-12 month contract opportunity. APPLY NOW!
Responsibilities for the Trainer
- Develop and conduct GMP and QMS training for the company, and implementing and managing the company electronic Learning Management System (eLMS) including end-user support.
- Assess and determine appropriate QMS and current Good Manufacturing Practices (GMP) training requirements
- Design & Development, Validation, Manufacturing, Distribution and Post-Market Compliance of Medical Device and IVD products.
- Owns the GMP and QMS training materials and ensures content is current and in compliance with applicable medical device regulations and standards (e.g. FDA QSR, ISO 13485) and internal procedures.
- Developing materials for and conducting Train the Trainer courses for designated employees.
- Work with Project Leads to determine required QMS and GMP training for project-specific personnel involved in medical device and IVD projects.
Requirements for the Trainer
- Bachelor's degree, with preference given to those in basic (e.g. biology, chemistry, physics, etc.) or life (e.g. physiology, human biology, etc.) sciences required
- 3+ years' experience in a training role or other quality-related function in a medical device or other regulated/GMP environment.
- Working knowledge of current Good Manufacturing Practices (GMP), 21 CFR Part 820 and ISO 13485:2016.
- Experience administering and/or using an eLMS, with preference given to candidates who have assisted in the implementation of an eLMS.
- Prior experience developing and conducting training, most notably QMS/GMP training.
- Comprehensive benefit package