John J. Hopkins has over 20 years of experience in the pharmaceutical industry as a training specialist and quality assurance professional. He holds an MS in Biology from Adelphi University and a BS in Biology from Virginia Military Institute. Currently he is a Training Specialist IV at Forest Laboratories, where he develops and implements GMP/GLP training programs. Previously he worked at Watson Pharmaceuticals as a Quality Assurance Training Specialist, where he managed their training database. He has extensive experience training employees on regulatory compliance issues.

1. John J. Hopkins
Mastic Beach, NY 11951
Home: (631) 772-8004 | Cellular: (631) 605-2481 | hoppi@optonline.net
EDUCATION
Adelphi University. Garden City, NY. MS in Biology, August 2000.
Virginia Military Institute. Lexington, VA. BS in Biology May 1995.
EMPLOYMENT HISTORY
Forest Laboratories, Inc. Commack, NY 4/06 – Present
Training Specialist IV
 Supporting the various product development functions (analytical, method development, stability, pre-formulation/formulation, bio-
analytical and clinical manufacturing/packaging) in the development, conducting and administration of an effective and innovative
training program for R&D professionals
 Strong training background on GLP’s / GMP’s and Good Documentation Practices that extend into SOP training and
technical issues specific to each group
 Developing and implementing an effective SOP/GLP/GMP compliance training program using the ADDIE model
 Aiding department management in development of training programs for job specific training
 Evaluating and benchmarking GLP/GMP training programs within the industry
 Developing unique GMP/GLP training programs specific to current industry trends recent topics include: Good Documentation
Practices, Current FDA Enforcement & CAPA, Comparing the EMEA & FDA Regulations on IMPs/MPs, Comparing the OECD &
FDA GLPs, Proactive Compliance
 Focusing training effort based on results of audit reports, FDA Guidelines and industry trends
 Developing and implementing effectiveness checks to assure understanding of training material
 Implemented Saba training platform within PRD
 SME for all Saba related issues for PRD and various regulatory inspections
 Using the Saba platform created a unique way of an electronic sign-off-eliminating 90-95% of all training paperwork
 No 483 observations during various ( IMB/ FDA pre-approval/ FDA Bio-equivalences Studies in GLP) inspections within training
Watson Pharmaceuticals, Inc. Copiague, NY 11/01 – 4/06
Quality Assurance Training Specialist Senior
 Implemented the ISOtrain training database at the Copiague Site
 Site System Administrator for the ISOtrain database and SME for FDA inspections
 Implemented two ISOtrain PQ's related to moving to the Citrix server to provide internal customers with timely reports
 Interacted with corporate for ISOtrain IQ, OQ, PQ, and validation requirements to comply with Part 11
 Interacted and helped with new system start-ups at corporate and other sites
 Performed internal audits of ISOtrain system to enable customers to have appropriate information to make GMP decisions
 Used analytical skills to investigate and troubleshoot Part 11 compliance ISOtrain related issues
 Used investigative skills to do compliance audits on the ISOtrain system
 Involved with corporate and other sites in evaluating newer versions of ISOtrain and other potential training databases to
meet the company’s futures needs
 Identified issues and implemented corrective actions to solve root cause of ISOtrain problems
 Provided support, direction and coaching to ISOtrain system users in the areas of training, problem resolution and planning
 Trained over 200 new employees in GMP and GDPs
 Delivered scheduled GMP training to site employees
 Developed innovative GMP and GDP training programs (DVD Videos, pictures, games)
 Site GMP trainer and line trainer
 Experienced in Trackwise and the CAPA process
 Involved with site management in the LIMS implementation project within the laboratory, R&D and QA personnel
 Implemented and designed spreadsheets to provide site management with factual information as to where the site and
individual department stand with respect to training on a daily and weekly basis
 Observe and provide feedback on the training effectiveness at the site to department management and supervisors
 Implemented and designed spreadsheets for Laboratory and Quality Assurance for financial capacity planning
 Implemented and designed spreadsheets for Purchasing, Production, and Inventory Control to better manage and prepare
for production flow and financial decision making

2. John J. Hopkins | Mastic Beach, NY 11951
Home: (631) 772-8004 | Cellular: (631) 605-2481 | hoppi@optonline.net
Laboratory Trainer
 Ensured that all personnel were trained in the essentials of complying with GMPs, GLPs, and GDPs within the laboratory
 Comprehensively trained all personnel to meet the objectives and purposes of all SOPs in the laboratory department
 Assisted in the creation of training modules for each job function within the laboratory
 Implemented and developed SOP training and qualification programs for all laboratory personnel
 Directed and conducted all laboratory training and administering evaluations to determine the effectiveness of the training
program
 Trained new chemists in all essential safety SOPs
 Implemented a laboratory orientation program for all new chemists
 Updated laboratory training program to respond to new SOP system
Adelphi University, Garden City, NY 5/98 - 8/00
Teaching Assistant/ Laboratory Manager/ Research Scientist
 Gained expertise in teaching college level biology courses and laboratories
 Responsibilities included lecturing, teaching, training, tutoring, proctoring and lab preparation
 Supervised and trained undergraduates in both molecular biology techniques and equipment
 Gained experience in laboratory management and research skills
 Duties included responsibility for immunology and virology lab, direction of undergraduates, two mouse colonies (HIV
Transgenic and tumor) in the animal facility, four cell culture lines (PC12, Vero, Hela, HaCaT) and several scientific research
experiments
 Helped coordinate specific projects and protocol development
 Selected from over 100 masters students for the position
 Two accepted research projects for publications in major scientific journals
United Parcel Service Inc., Uniondale, NY 12/97 -11/01
Supervisor
 Responsible for dispatching over 50 UPS trucks
 Responsible for over 17,000 packages serviced daily
 Duties included responsibility for service, training, quality, efficiency and production within the facility with over 30 employees
 Promoted to management within the first five months of working with company
 Supervised Oceanside center in which seven trainees currently made book under my tutelage
 Transferred to Garden City center to help rebuild former production levels
 Member: Preload Damage Committee
 Awarded: Supervisor of the Month, March 2000
 Supervised primary unload operations, primary unload small sort and air operations
A.S.P.A. Management Corporation, Patchogue, NY 8/95 -12/97
Assistant Manager/ Manager
 Managed all facets in facility operations
 Duties included customer service, responsibility for staff, training and security within the facility
 Responsible for all facility operations and accountable for $380,000 of current inventory and $1.5 million in gross funds a year
 Obtained $30,000 reduction of inventory through effective management of staff
 Promoted to management within first three months of working with corporation
 Managed new facility during development stage of expanding corporation
SPECIAL SKILLS
 GMP Trainer Certification (Skills Plus International)
 Skilled in Adult Learning Theory
 Highly Skilled in using the ADDIE process for Adult Learning Theory
 Training Database Implementation
 Training Database Management
 Over 14 years experience using various Learning Management Systems
 Certified: Current Good Manufacturing Practice (cGMP) and FDA Inspections for the Pharmaceutical and Allied Industries
(21 CFR 210-211) (1.8 CEU)

3. John J. Hopkins | Mastic Beach, NY 11951
Home: (631) 772-8004 | Cellular: (631) 605-2481 | hoppi@optonline.net
 Certified: Hazardous Waste Operations and Emergency Response (29 CFR 1910.120)
 Certified: Haz-Mat Employee (49 CFR, Docket HM-126F)
 Certified: Hazwoper Awareness (29 CFR 1910.120)
 Certified: CPR (American Heart Association)
 Certified: First Aid (National Safety Council)
 Proficient with the use of Microsoft applications (Word, Excel and PowerPoint)
 Highly skilled in all levels of ISOtrain training database management system
 Highly skilled in all levels of the Saba platform training system
 Experienced in eDocs, TrackWise, LIMS, e-notebook, POMS
 Experienced trainer in controlled substances and Ab+
 Member: Emergency Spill Response Team (Watson)
 Member: Site Safety Committee (Watson)
 Member: Laboratory Safety Committee (Watson)
 Coordinated a Laboratory Safety Committee (Watson)
 Bred and worked with FVB/N-TG26 HIV Transgenic Mice using HSV-1 and -2
 Experienced in growth and liter of HSV-1 and -2 using Monkey Kidney (Vero) cells
 Proficient in the use and instruction of southern blot, gel electrophoresis, PCR, SDS polyacrylamide gel, SDS-PAGE
Electrophoresis, aseptic techniques, tissue and cell culture, monoclonal antibodies, ELISA, UV, IR, GC and standard wet
chemical techniques
 Maintained and operated animal facility at Adelphi University
RESEARCH AND PUBLICATIONS
 Herpes Simplex Virus Type-1 and -2 Pathogenesis is Restricted by the Epidermal Basement Membrane. Archives of Virology 2000;
145:385-396.
 HIV Surface glycoprotein gp-120 Enhances HSV-1 Pathogenesis. UMI Dissertation Services. UMI Number: 1400280