Compli, LLC

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Compli, LLC Employees

Employee
Years
Job
Industry
Bruce Huval Bruce Huval Greater New Orleans Area Details
Bruce Huval's Compli, LLC Experience January 2001 - Present
Job Owner, Compli, LLC
Industry Pharmaceuticals
Experience
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

RICARDO Torres-Rivera RICARDO Torres-Rivera Puerto Rico area Details
RICARDO Torres-Rivera's Compli, LLC Experience June 2013 - December 2013
Job CSV Consultant at ProPharma Group
Industry Pharmaceuticals
Experience
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

Jay Goldberg Jay Goldberg Greater Philadelphia Area Details
Jay Goldberg's Compli, LLC Experience December 2001 - Present
Job Chief Financial Officer at Compli. LLC
Industry Pharmaceuticals
Experience
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.)

Zachary Smiley Zachary Smiley Swiftwater, Pennsylvania Details
Zachary Smiley's Compli, LLC Experience February 2012 - June 2013
Job Manager Quality Validation at Sanofi Pasteur
Industry Pharmaceuticals
Experience
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

James Vroman James Vroman Rochester, Minnesota Details
James Vroman's Compli, LLC Experience December 2004 - January 2008
Job Senior Software Quality Engineer
Industry Medical Devices
Experience
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

Anthony Petrigni Anthony Petrigni Birmingham, Alabama Area Details
Anthony Petrigni's Compli, LLC Experience November 2014 - Present
Job Validation Specialist at Evonik Industries (Contract)
Industry Pharmaceuticals
Experience
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 Cohn Lawrence Cohn Greater Philadelphia Area Details
Lawrence Cohn's Compli, LLC Experience June 2010 - September 2010
Job CEO, CTO, President Lawrence J Cohn Contracting
Industry Pharmaceuticals
Experience
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

Randall Howard Randall Howard Tampa/St. Petersburg, Florida Area Details
Randall Howard's Compli, LLC Experience November 2000 - February 2002
Job Distinguished Quality Director with the vital skills to lead a pharmaceutical, medical device company towards excellence
Industry Pharmaceuticals
Experience
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

Marsha Holt Marsha Holt Kansas City, Missouri Area Details
Marsha Holt's Compli, LLC Experience October 2009 - Present
Job Quality Assurance / Validation Consultant
Industry Pharmaceuticals
Experience
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

Sandra Nolte Sandra Nolte Greater Boston Area Details
Sandra Nolte's Compli, LLC Experience January 2011 - December 2011
Job Validation Consultant
Industry Biotechnology
Experience
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