James is an instructional designer with more than 20 years’ experience providing learning and development solutions in the Biotech industry. He is adept in GMP training and managing Quality Assurance personnel and has a reputation for authoring clear and comprehensive guidelines, procedures, presentations and publications. His education includes a master’s degree in Pharmaceutical QA/RA from Temple University.
Sampling of Projects
- At Merck & Company, James authored global guidelines on Selection and Testing of High Purity/Process Water Systems, and co-authored divisional guidelines on environmental monitoring. He conducted formal training on environmental control and water systems validation for global sites including Spain, Puerto Rico, Malaysia, France, the United Kingdom and the US.
- At Astrazeneca, James created a comprehensive computer-based training program with practice session for approximately 1,000 system users.
- At ImClone, James created a comprehensive course on pharmaceutical water systems.
- At Shire Pharmaceuticals, James provided cGMP training for Engineering and Utilities staff.
- At Wyeth, James worked with subject matter experts to develop materials for instructor-led training on the company’s worldwide adverse event reporting database. Instructed new hire and safety surveillance training.
- MS, Pharmaceutical QA/RA, Temple University
- BA, Psychology, Indiana University of Pennsylvania