Compli, LLC
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Compli, LLC Employees
Compli, LLC January 2001 - Present
The Validation Group 1997 - 2001
Jacobs Engineering, Inc. 1995 - 1997
Raytheon Engineers and Constructors 1990 - 1995
Skills
Project Management, Automation, Start-ups, Quality Assurance, Business Development, GMP, Technology Transfer, Validation, Pharmaceutical Industry, FDA, Team Building, New Business Development, Cross-functional Team..., Testing, Medical Devices, Quality System, Sop, Change Control, Computer System..., 21 CFR Part 11, Process Simulation, Biotechnology, Process Improvement, Quality Auditing, ISO 13485, Quality Control, V&V, Lifesciences, Pharmaceutics, Regulatory Affairs, Software Documentation, CAPA, Program Management, Quality Management, R&D, Process Engineering, Document Management, SOP
Education
Southeastern Louisiana University
Bachelor's of Science
ProPharma Group March 2014 - Present
Compli, LLC June 2013 - December 2013
Independent Consultant: IT Management March 2006 - June 2013
NSHMBA 2003 - 2008
Eli Lilly and Company September 1999 - August 2005
Skills
Program Management, SDLC, SharePoint, Team Leadership, Business Analysis, Project Management, ITIL v3 Foundations..., ITIL Service Strategy, EHS Management Systems, Software Design, Strategic Communications, Document Management, SOP development, Database Design, Economic Development, Technological Innovation, Technology Transfer, GIS systems, Business Workflows, Technology Roadmapping, Technology Needs..., Instructor-led Training, SWOT analysis, Persuasive Presentations, Business Intelligence..., Change Management, Technical Support, Customer Service, IT Project Leadership, Root Cause Analysis, Deviation Management, Computer System..., 21 CFR Part 11, Risk Assessment, Test Management, IT Audit, Databases, Governance, Testing, Validation, Visio
Education
University of Puerto Rico-Rio Piedras 1995 — 1999
Bachelor of Business Administration (BBA), Management Information Systems, General
University of Puerto Rico-Rio Piedras
Master in Planning, Development Economics and International Development
Compli. LLC December 2001 - Present
The Validation Group September 1998 - November 2001
Avellino's Tire & Auto Centers January 1991 - September 1998
Skills
Financial Analysis, Forecasting, Financial Reporting, Managerial Finance, Financial Modeling, Accounting, Internal Controls, Strategic Financial..., Corporate Finance, Budgets, Finance, Business Planning
Education
Drexel University - College of Business and Administration 1994 — 1996
Master of Business Administration (M.B.A.), Accounting Control
Muhlenberg College 1985 — 1989
Bachelor of Arts (B.A.)
Sanofi Pasteur March 2015 - Present
Intuitive Technology Solutions June 2013 - January 2015
Compli, LLC February 2012 - June 2013
Validation Technologies, Inc. August 2011 - February 2012
Experis September 2010 - August 2011
ManpowerGroup June 2010 - September 2010
Chaperone Technologies, Inc September 2009 - December 2009
Proctor and Gamble June 2002 - September 2003
Skills
Validation, Quality Assurance, GMP, Cleaning Validation, 21 CFR Part 11, CAPA, Vaccines, Manufacturing, Change Control, Technical Writing, Deviations, Pharmaceutical Industry, GLP, LIMS, GAMP, GxP
Education
East Stroudsburg University of Pennsylvania 2005 — 2010
BA, Chemistry
Tunkhannock Area High School
Preventice January 2015 - Present
Independent Consultant March 2014 - January 2015
Datalynx US, Inc. October 2013 - February 2014
CVRx February 2008 - July 2013
Compli, LLC December 2004 - January 2008
Skanska USA Building Inc. September 2003 - November 2004
Foster Wheeler June 2001 - September 2003
NNE Pharmaplan (Formerly Flaval Validation Group) December 2000 - June 2001
NNE Pharmaplan (Formerly Flaval Validation Group) March 1998 - December 2000
Vroman Systems Validation February 1996 - March 1998
Skills
Validation, 21 CFR Part 11, Computer System..., ISO, Quality Assurance, GMP, Requirements Analysis, FDA, Medical Devices, Risk Management, Agile, Compliance, Software Quality..., Auditing, Quality Systems, Change Management, Documentation, Software / Firmware QSR..., QSR, Quality System, IEC 62304, Medical Device Directive, Part 820, ISO 14971, Class III Medical..., Agile Methodologies, Sop, GLP, GAMP, Software Documentation, GxP, Quality Control, ISO 13485, V&V, Root Cause Analysis, Quality Management, Testing, CAPA, Design Control, R&D, Continuous Improvement, Change Control, Process Simulation, Quality Auditing, Automation, Manufacturing, Regulatory Affairs, Minitab, Product Development, Six Sigma
Education
Almeda University
Bachelor of Science (BS), Computer Science
Columbia Centro Universitario-Caguas 1993 — 1994
Administration
University of New Hampshire 1988 — 1988
Business
Universidad del Turabo 1986 — 1986
Programming
Universidad de Puerto Rico 1981 — 1982
Accounting
Compli, LLC November 2014 - Present
Compli, LLC November 2014 - Present
Castle Validation November 2011 - October 2014
Lyophilization Services of New England May 2005 - December 2010
Bio-Concept Laboratories, Inc. February 2003 - May 2005
HADCO / Sanmina-SCI May 1988 - August 2001
Skills
GMP, Validation, CAPA, Change Control, Manufacturing, Quality System, Quality Assurance, Technical Writing, Deviations, Discrepancy Resolution, Aseptic Technique, Aseptic Processing, Cleaning Validation, FDA GMP, Sterilization, Clean Rooms, External Validation
Education
UMass Lowell 1993 — 2014
BS Mechanical Engineering Technology, Mechanical Engineering
Lawrence J Cohn Contracting January 2008 - Present
Compli LLC June 2010 - September 2010
Teva Pharmaceuticals 2008 - 2009
Merck & Co. Inc. April 1973 - June 2007
Skills
Validation, GMP, Pharmaceutical Industry, Technology Transfer, Sop, HPLC, FDA, Analytical Chemistry, CAPA, Quality System, 21 CFR Part 11, Quality Assurance, SOP
Education
Drexel University 1968 — 1973
BS, Chemistry and Biology
RK Howard Enterprises Inc. April 2001 - Present
Ion Labs, Inc. September 2012 - September 2013
Formulated Solutions March 2009 - August 2012
Watson Laboratories February 2002 - September 2004
Compli, LLC November 2000 - February 2002
Vital Signs May 1996 - June 2000
Becton Dickinson May 1990 - February 1996
Skills
GMP, FDA, Quality Assurance, Validation, Quality System, Pharmaceutical Industry, Continuous Improvement, Analytical Chemistry, HPLC, V&V, Regulatory Affairs, Medical Devices, Management, R&D, Sop, Quality Auditing, Change Control, Recruiting, CAPA, Deviation and..., NDA, ANDA, NADA, PMA,..., Six Sigma, Process/Product..., Equipment Qualification, Multicultural Business..., Training and Development, Crisis Management, Multicultural Team..., Client Relationship..., Cross Functional..., Performance Optimization, Warning Letter..., 21 CFR Part 111, ISO 13485, ISO 9000, 21 CFR Part 210/211, Risk Assessment, Product Complaints, 21 CFR 211, CMDCAS, MHRA, TGA, ANVISA, ICH, ISO 14971 Risk..., Laboratory Management, Technical Asessments, Gap Analysis, Stability Studies, Recalls
Education
University of Maryland Baltimore County 1985 — 1989
BA
Regulatory Affairs Professional Society
Certificate in Regulatory Affairs
Villanova University
Master Certificate Six Sigma - Black Belt, Lean Six Sigma, Greenbelt Coursework
Evonik Laboratories January 2015 - Present
Compli LLC October 2009 - Present
Nesher Pharmaceuticals (USA) LLC October 2009 - May 2013
Evonik 2013 - 2013
Bayer HealthCare 2007 - 2009
Crabtree & Associates, LLC March 2005 - June 2007
Performance Validation 2003 - 2005
Bayer HealthCare 1995 - 2000
Sanofi Winthrop 1991 - 1994
Marion Merrell-Dow 1981 - 1991
Skills
FDA, Validation, Laboratory Equipment, Aseptic Technique, Information Systems, GLP, GMP, Quality Assurance, Aseptic Processing, GxP, Quality System, Pharmaceutical Industry, Quality Control, 21 CFR Part 11, Medical Devices, Change Control, GAMP, Sop, Pharmaceutics, Technology Transfer, Regulatory Requirements, SOP development, Trackwise, Document Management, Equipment Qualification, CAPA, V&V, Software Documentation, Microbiology, Quality Auditing, Cleaning Validation, LIMS, Regulatory Affairs, Biopharmaceuticals, Regulatory Submissions, Biotechnology, Laboratory, HPLC, Chromatography, Analytical Chemistry, Lifesciences, ISO 13485, Vaccines, GCP, Clinical Trials, Process Simulation, Drug Development, R&D, Computer System..., SOP
Education
Avila University 1989 — 1990
Natural Science
Longview Community College 1986 — 1988
Associate of Arts, Emphasis in Science
Genzyme May 2014 - October 2014
Histogenics September 2013 - May 2014
Compli LLC January 2011 - December 2011
Shire (ICQ Consultants) February 2010 - June 2011
Biogen Idec October 2007 - December 2009
Bayer July 2006 - May 2007
Sanofi Pasteur February 2006 - May 2006
Massachusetts Public Health Biologic Laboratories April 2005 - January 2006
Biovest January 2005 - April 2005
Amgen December 2003 - October 2004
Skills
Validation, CAPA, V&V
Education
Boston University 2004 — 2005
Universidad de Los Andes 1988 — 2003
BA
University of Massachusetts Lowell
Biotechnology
Worcester Polytechnic Institute
MBA