James DeCarlo

I have been in Pharmeceutical Manufacturing for over 20 years.

Most recently I have been a contract Validation Engineer.

Twenty years of experience in the highly-regulated cGMP/cGLP Pharmaceutical and Medical Device industries.  Experience includes several years of Production Management at various pharmaceutical manufacturers, writing SOPs, deviations, non-conformance reports, and hands-on supervision and training of technicians.  All the while learning and implementing cGMP, cGDP, to meet FDA regulations, as well as ISO, OSHA, and EU standards. 

Went on to become a Quality Engineer in QA roles such as Technical Writing, batch record review, and deviation, NCR, OOS investigations, Root Cause Analysis, and close-outs.  Mastered the writing, execution, and summarizing of equipment commissioning, IQs/OQ/PQs and cleaning protocols, as well as Validation Master Plans, as a Sr. Validation Engineer.  Well versed in QA, QC, Project Management, GMP compounding and packaging of solids, oral liquids, and sterile injectables. 

An expert in Microsoft Office and well-rehearsed with many types of software including MS-Project, LIMS, SharePoint, TrackWise, AutoCAD, SolidWorks, and Visio.  A team player, highly motivated, and also works well independently to achieve project goals.  Always well organized.

BS in Biochemistry from SUNY Stony Brook.