Jason Fitz

ADJUNCT PROFESSOR
School: Schaefer School of Engineering & Science
Department: Mechanical Engineering
Email: jfitz@stevens.edu
Education
  • MS Pharmaceutical Manufacturing, Stevens Institute of Technology 
  • Graduate Certificate Validation & Regulatory Affairs, Stevens Institute of Technology
  • Graduate Certificate Pharmaceutical Manufacturing, Stevens Institute of Technology
  • BS Environmental Science, Ramapo College of NJ
General Information

I am an Associate Director of Quality Operations at Regeneron Pharmaceuticals in Tarrytown, NY. Within this role I am responsible for providing professional expertise and leadership in the Quality function. I oversee the Quality Operations processes and direct the activities of my team with respect to Quality Systems (deviations, CAPA, change control, training, metrics), Information & Records Management (GLP Archives, Documentation Repository, Documentation Control), QA Project Management, and QA & Operations Training.

 

I am a graduate of Stevens with a MS in Pharmaceutical Manufacturing. I enjoyed my classes, the learning experience, my professors and Stevens so much that I sought a way to give back, and had the opportunity to do so when I joined the Stevens External Advisory Board for Pharmaceutical Manufacturing & Engineering (PME) Graduate Program. I have been a adjunct faculty member since 2016.

Experience
  • 2016-Present, Associate Director Quality Operations, REGENERON PHARMACEUTICALS, INC., Tarrytown, NY
  • 2014-2015, Acting Manager QAA GLP, REGENERON PHARMACEUTICALS, INC., Tarrytown, NY 
  • 2013-2015, Senior Manager QAA Quality Systems, REGENERON PHARMACEUTICALS, INC., Tarrytown, NY
  • 2008-2013 Quality Improvement Manager, MERCK, Summit, NJ 
  • 2006-2008 Senior QA Specialist, MERCK, Summit, NJ 
  • 2004-2006, Owner, MAXCOM CONSULTING, LLC, Montclair, NJ 
  • 2004-2005, Manager of Quality, DAY & ZIMMERMAN VALIDATION SERVICES, Philadelphia, PA 
  • 2002-2004, QA Compliance Specialist, SCHERING-PLOUGH, Kenilworth, NJ 
  • 2000-2002, GMP Quality Systems Specialist, KIEHL’S SINCE 1851 (L’OREAL) WEST CALDWELL, NJ 
  • 1998-2000, Analytical Chemist, SCHERING-PLOUGH KENILWORTH, NJ 
  • 1997-1998, Radiation Safety Lab Technician, HOFFMAN-LA ROCHE, NUTLEY, NJ
Professional Service
  • Certified Manager of Quality / Organizational Excellence, ASQ, License 17749
  • Mini-MBA Course, Bottom Line Training and Consulting
  • Certified Change Agent, Merck
  • Certified Lean Practitioner Lean Manufacturing Program, EMS Consulting Group
  • Lean Six Sigma Black Belt, Six Sigma Partnering, LLC and Merck
  • Certified Lead Auditor Computer Vendors, Schering Plough
Honors & Awards
  • Outstanding Academic Achievement Award MS in Pharmaceutical Manufacturing Program, Stevens Institute of Technology
  • Design & Assessment of Effective 15 Minute Training, PDA Biennial Training Conference, May 2006
Selected Publications
Magazines
  1. Jason C. Fitz. (2006). "Laboratory Instrument Qualification: Solving the Puzzle", Pharmaceutical Engineering, Mar/Apr, 26 (2).
  2. Jason C. Fitz. (Oct 2005). "How to Validate a Tablet Press", Tablets & Capsules, 3 (7).
  3. Jason C. Fitz. (Aug 2005). "How OTCs Win with GMPs", CI.
  4. Jason C. Fitz. (2005). "Be Trained to Train", ISPE PharmaBulletin, March/April, 12 (2).
  5. Jason C. Fitz. (2004). "The Deviation Lifecycle", NGP Next Generation Pharmaceutical, 1 (Q4), I.
  6. Jason C. Fitz. (2004). "If You Build It, They Will Come How to Build a Training Plan and Program", ISPE PharmaBulletin, May/June, 11 (3).
Courses
  • PME 530 Introduction to Pharmaceutical Manufacturing
  • PME 542 Global Regulation and Compliance in the Pharmaceutical Industry