Regulatory Compliance Associates Inc.
Address: 10411 Corporate Dr #102, Pleasant Prairie, WI 53158 Hours: Closed ⋅ Opens 9AM Wednesday9AM–5PMThursday9AM–5PMFriday9AM–5PMSaturdayClosedSundayClosedMonday9AM–5PMTuesday9AM–5PMSuggest an edit Unable to add this file. Please check that it is a valid photo. Phone: (262) 288-6300: Category: : : : Website: : Place name: : Website: http://www.rcainc.com/ Category: Corporate office Suggest an editUnable to add this file. Please check that it is a valid photo. Unable to add this file. Please check that it is a valid photo. Questions & answers Ask a questionBe the first to ask a question Add a photoThanks for sharing!Your photo will be posted publicly on Google.Contribute MoreDoneUpload public photos of Regulatory Compliance Associates Inc. Posting publicly on the Web Write a review Reviews Be the first to review
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Regulatory Compliance Associates Inc. Employees
Aon Hewitt September 2015 - Present
RL Canning October 2012 - September 2015
DeVry University November 2010 - October 2012
Regulatory Compliance Associates, Inc February 2009 - September 2010
Skills
Student Affairs, Sourcing, Recruiting, Interviews, Customer Service, Admissions, Enrollment Management, College Recruiting, Management, Networking, Higher Education, Coaching, Resume Writing, Microsoft Office, Training, Microsoft Excel, Social Networking, Leadership, Applicant Tracking...
Education
University of Missouri-Columbia 2004 — 2008
Bachelor’s Degree, Political Science
Nypro, a Jabil Company April 2014 - Present
Jabil October 2012 - Present
Jabil August 2011 - March 2014
Regulatory Compliance Associates, Inc. August 2009 - August 2011
Baxter Healthcare April 2004 - August 2009
Baxter Healthcare May 1998 - March 2004
Baxter Healthcare 1996 - 1998
Baxter Healthcare August 1994 - May 1996
Hecules Defense Electronics August 1987 - August 1994
Skills
Medical Devices, Product Development, Risk Management, FDA, Design Control, CAPA, Validation, ISO 13485, V&V, R&D, Quality System, GMP, ISO 14971, Manufacturing, Cross-functional Team..., Process Improvement, ISO, Testing, Quality Assurance, Quality Management, Engineering, Program Management, FMEA, Leadership, Management, Lean Manufacturing, Root Cause Analysis, Electronics, Continuous Improvement, 21 CFR Part 11, DMAIC, Design of Experiments, SPC, Systems Engineering, Process Engineering, Design for Manufacturing, Integration, Engineering Management, Process Simulation, Change Control, Supplier Quality, Contract Manufacturing, Quality Auditing, Manufacturing..., Quality Control, Manufacturing Operations, Product Lifecycle...
Education
Massachusetts Institute of Technology - Sloan School of Management 2001 — 2004
University of South Florida 1981 — 1987
BSEE, Circuit Design
Regulatory Compliance Associates Inc. October 2014 - Present
Baxter Healthcare 1993 - 2010
Skills
Quality Management, Quality System, Training, FDA GMP, ISO 13485, Consulting, Compliance, Program Management, Medical Devices, Change Control, Biotechnology, Organizational..., CAPA, Validation, FDA, Biopharmaceuticals, Pharmaceutical Industry, Complaint Management, Quality Auditing, Regulatory Requirements, Sop, Quality Assurance, Quality Control, ISO 14971, Design Control, GMP, Aseptic Processing, V&V, Regulatory Submissions, 21 CFR Part 11, Computer System..., Quality System...
Education
Judson University
Bachelor of Science (B.S.), Biology/Biological Sciences, General
Regulatory Compliance Associates Inc. January 2015 - Present
Regulatory Compliance Associates, Inc. (RCA) May 2013 - Present
The Insight Talent Solutions October 2011 - April 2013
Wheaton Franciscan Healthcare July 2011 - April 2013
Lockstep Solutions LLC September 2011 - October 2011
Insight Talent Solutions September 2008 - March 2009
Skills
Technical Recruiting, Sourcing, Interviewing, End to End Recruiting, Applicant Tracking..., Internet Recruiting, Talent Acquisition, Screening Resumes, Contract Recruitment, Staffing Services, Screening, Recruiting, Interviews, Training, Talent Management, Vendor Management, Leadership, Management
Education
Marquette University 2008 — 2008
SHRM Certificate, Essesntials in Human Resources
Delhi University 2000 — 2002
Masters, Social Work with emphasis in Human Relations and Employee Welfare
Delhi University 1997 — 2000
Bachelors, Sociology
Regulatory Compliance Associates Inc. August 2014 - Present
Career Break for One year Round the World Travel February 2013 - Present
Nutrilite June 2004 - February 2013
Upsher-Smith Laboratories July 1998 - June 2004
Merial, A Sanofi Company September 1991 - July 1998
Education
Texas Lutheran 1987 — 1991
Bachelor of Arts (B.A.), Chemistry
ProPharma Group October 2013 - Present
Quality Core Consulting, LLC June 2013 - Present
Sprout Pharmaceuticals June 2013 - October 2013
Regulatory Compliance Associates, Inc. February 2013 - April 2013
Quintiles November 2011 - September 2012
Pfizer Pharmaceuticals October 2008 - November 2010
Wyeth Biotech 2007 - 2008
Wyeth Vaccines 2005 - 2007
Bayer July 1994 - January 2005
Skills
Quality Assurance, Quality Management, Quality Operations, Quality Systems, Quality Auditing, cGMP, Batch Release, Documentation Practices, Document Control, Annual Reports, Change Control, LIMS, SAP, Livelink, Lean Manufacturing, Root Cause Analysis, Validation, Process Validation, Cleaning Validation, Pharmaceuticals, Biotechnology, Vaccines, Aseptic Processing, Trending, Collaboration, Strategic Communications, Pharmaceutical Industry, V&V, GMP, Quality System, FDA, Software Documentation, Document Management, Manufacturing, CAPA, Cross-functional Team..., Technology Transfer, Process Simulation, 21 CFR Part 11, GLP, Computer System..., Sop, Biopharmaceuticals, Continuous Improvement, Pharmaceutics, Regulatory Submissions, Trackwise, Regulatory Requirements, ISO 13485, Deviations
Education
North Carolina State University - College of Management 1990 — 1993
BA, Business Administration, concentration in Marketing
Wayne Community College 1988 — 1990
ALKU Consulting May 2015 - Present
Regulatory Compliance Associates Inc. October 2014 - March 2015
Validant January 2014 - August 2014
ABC Laboratories November 2011 - January 2014
Patheon Pharmaceutical July 2010 - May 2011
DSM Pharmaceutical January 2009 - July 2010
Norwich Pharmaceutical July 2007 - September 2008
Quality Chemical Laboratories May 2004 - January 2007
Pfizer July 2001 - January 2003
Skills
HPLC, UV/Vis, Validation, FTIR, Dissolution, Method Development, TOC, Viscosity, GMP, LIMS, Gas Chromatography, Analytical Chemistry, Sop, FDA, Pharmaceutical Industry, Chemistry, USP, Cleaning Validation, GLP, UV, GC-FID, GC-Headspace, Laboratory, Wet Chemistry, V&V, CAPA, ELISA, TLC, Quality Control, Assay Development, Organic Synthesis, Empower, Biochemistry, SOP
Education
S.U.N.Y Plattsburgh 2003 — 2004
Master of Arts, Natural Science
S.U.N.Y Plattsburgh 1998 — 2001
Bachelor of Science, Cellular Biochemistry
State University of New York College at Plattsburgh 1998 — 2001
BS, Cellular Biochemistry
Avarent LLC January 2012 - Present
Regulatory Compliance Associates, Inc. May 2009 - January 2012
Baxter Healthcare Corporation 2005 - 2009
Baxter Healthcare 2002 - November 2005
Baxter Healthcare 1999 - 2002
Baxter Healthcare 1992 - 1999
Baxter Healthcare 1989 - 1992
Baxter Healthcare 1986 - 1989
Skills
ASQ, Validation, ISO 13485, CAPA, Quality System, FDA, Quality Auditing, Design Control, ISO 14971, Change Control, Calibration, Quality Management, GLP, Continuous Improvement, Six Sigma, GxP, V&V, Aseptic Processing, ISO, Quality Assurance, R&D, GMP, Supplier Quality, Computer System..., Product Development, Medical Devices, Manufacturing, Regulatory Affairs, Quality Control, Pharmaceutical Industry, Document Management, Sop, Software Documentation, Regulatory Submissions, Regulatory Requirements, 21 CFR Part 11, Cleaning Validation, Technology Transfer, LIMS, Biopharmaceuticals, Biotechnology
Education
Loyola University Chicago 1972 — 1979
BS, Biology
Dellshire Development and Compliance Inc. July 2011 - Present
Regulatory Compliance Associates, Inc. May 2008 - June 2011
Baxter Healthcare, Cellular Therapies 2005 - 2008
Baxter Healthcare, Corporate Engineering 2003 - 2005
Baxter Healthcare 2000 - 2003
Baxter Healthcare, IV Systems Div. 1993 - 1999
Skills
Product Development, Medical Devices, Operations Management, Project Management, Strategy, Manufacturing, Organization, Pharmaceutical Industry, Lean Manufacturing, Six Sigma, Quality System, FDA, Leadership, ISO 13485, CAPA, Design Control, V&V, Validation, GMP, Integration, Cross-functional Team..., Management, Business Process..., Commercialization, Engineering, Project Planning, Regulatory Affairs, Quality Auditing, Product Launch, R&D, Quality Assurance, CRM, Design of Experiments, Biotechnology, Regulatory Requirements, 21 CFR Part 11
Education
University of Illinois at Chicago 1976 — 1980
BS, Bioengineering
Regulatory Compliance Associates Inc. May 2008 - Present
CPJ Concepts, LLC 2011 - 2012
Hospira April 2004 - May 2008
Baxter 2000 - 2003
Baxter Healthcare 1995 - 2000
Baxter 1989 - 1995
Baxter November 1978 - January 1989
Skills
Medical Devices, Biotechnology, Quality Management, Manufacturing, Pharmaceutics, FDA, CAPA, Pharmaceutical Industry, Regulatory Affairs, GMP, Enterprise Product Risk..., Risk Assessment, Quality System, ISO 13485, Quality Auditing, Change Control, Sop, Biopharmaceuticals, 21 CFR Part 11, Regulatory Requirements, Quality Control, Quality Assurance, Technology Transfer, R&D, ISO, Regulatory Submissions, Continuous Improvement, Six Sigma, Lifesciences, Design Control, Cross-functional Team..., Computer System..., GLP, Product Launch, GxP, ISO 14971, Microbiology, Root Cause Analysis, Aseptic Processing, Clinical Trials, FDA GMP, CRO, Drug Development, Commercialization, SOP, Life Sciences
Education
University of Alabama in Huntsville 1973 — 1978
M.S., Microbiology
Mylan December 2014 - Present
Now Foods September 2013 - December 2014
Now Foods March 2012 - September 2013
Regulatory Compliance Associates, Inc. March 2012 - March 2012
First Priority, Inc January 2012 - March 2012
First Priority, Inc January 2011 - January 2012
IBA July 2009 - January 2011
IBA March 2007 - July 2009
United States Infrastructure Corp., Inc. (USIC) January 2002 - November 2006
Skills
CAPA, Aseptic Processing, cGMP, Validations, GMP, SOP, USP, Change Control, FDA, 21 CFR Part 11, Validation, GxP, Regulatory Requirements, Quality Auditing, Computer System..., Regulatory Affairs, Environmental Monitoring, Quality Systems, QC, Pharmaceuticals, Regulatory Submissions, Generics, Process Validation, GLP, LIMS, ISO standards, Contract Manufacturing, HPLC, Analytical Chemistry, Clean Rooms, Calibration, Quality Assurance, Pharmacovigilance, Life Sciences, Design Control, Aseptic technique, Gowning validation, Bioburden Studies, Sterility Testing, ASTM, Sop, Pharmaceutical Industry, Quality Management
Education
Joliet Junior College 2006 — 2009
General Studies & Biology, 3.67
Technology Center of DuPage 2000 — 2000
Certificate, Medical Laboratory Assistant, A
ETHICON Johnson & Johnson June 2015 - Present
Thermofisher Scientific November 2014 - March 2015
Baxter Healthcare via USDM October 2011 - December 2013
Leica Microsystems January 2011 - June 2011
Regulatory Compliance Associates, Inc. August 2010 - January 2011
US Data Management January 2009 - November 2010
US Data Management November 2009 - May 2010
2009 - 2009 Validant Consulting November 2009 - May 2010
Validant July 2009 - October 2009
Cardinal Health May 2006 - August 2008
Skills
CAPA, FDA, V&V, Quality System, Software Documentation, Root Cause Analysis, 21 CFR Part 11, Validation, GMP, Change Control, Sop, Pharmaceutical Industry, Biotechnology, Calibration, Computer System..., Cross-functional Team..., Design Control, FMEA, GLP, GxP, Hardware Diagnostics, ISO, ISO 13485, LIMS, Lifesciences, Manufacturing, Medical Devices, Pharmaceutics, Process Improvement, Quality Assurance, Quality Auditing, Quality Control, Regulatory Affairs, Regulatory Requirements, Six Sigma, Technical Writing, Testing, Trackwise, Documentation, Training, Continuous Improvement, Document Management
Education
Illinois State University 1993 — 1995
Bachelor, Biology
in Medical Laboratory Technology @ CLC 1993 — 1995
Bachelor of ScienceAssociate of Applied Science, Biology @ ISU
Regulatory Compliance Associates Inc. March 2015 - Present
Covidien July 2011 - February 2015
Regulatory Compliance Associates, Inc. August 2009 - July 2011
Baxter Healthcare June 2000 - August 2009
Beckman Coulter 1988 - 2000
Skills
Requirements Management, FDA, ISO 13485, Design Control, Embedded Systems, Medical Devices, Software Development, Safety Management..., Validation, Embedded Software, Software Engineering, Cross-functional Team..., R&D, Biomedical Engineering, Quality Assurance, Process Improvement, Quality Management, CAPA, Quality System, ISO 14971, Six Sigma, GMP, Engineering Management, V&V, ISO, Testing, Strategy, Management, 21 CFR Part 11, Continuous Improvement, Process Simulation, FMEA, Root Cause Analysis, Hardware Diagnostics, Computer System..., Product Development, Manufacturing, Systems Engineering, Design of Experiments, Product Launch, Change Control, DMAIC, Commercialization, Firmware, Process Engineering, Product Lifecycle..., Software Documentation, Automation
Education
Florida International University
Electrical Engineering & Computer Science
Florida International University
Montana Conservation Corps May 2014 - Present
Epic January 2012 - May 2014
White Buffalo Organic Farm August 2011 - October 2011
Cook County State's Attorney's Office June 2010 - August 2010
Self-Help Initiative Support Services August 2009 - December 2009
Regulatory Compliance Associates, Inc. June 2009 - August 2009
Skills
Community Development, Community Outreach, Teaching, Public Speaking, Microsoft Word, Copy Editing, Research, Customer Service, Editing, Microsoft Excel, Program Management
Education
Grinnell College 2007 — 2011
B.A., Political Science
University of Ghana 2009 — 2009
Political Science, Conflict Resolution, Literature of the African Diaspora
Johnsburg High School 2003 — 2007
Diploma
Regulatory Compliance Associates, Inc. April 2005 - Present
Regulatory Compliance Associates Inc. August 2013 - March 2014
Regulatory Compliance Associates Inc. May 2012 - August 2013
Regulatory Compliance Associates Inc. April 2011 - April 2013
Regulatory Compliance Associates Inc. January 2009 - March 2011
Regulatory Compliance Associates, Inc. April 2008 - January 2009
Regulatory Compliance Associates Inc. June 2006 - March 2008
Regulatory Compliance Associates Inc. September 2005 - July 2006
Regulatory Compliance Associates Inc. April 2005 - June 2006
Manpower Professional October 2004 - April 2005
Skills
Documentations, Complaint Management, Supply Management, CAPA, FDA, ISO 13485, Quality Assurance, Sop, V&V, Biotechnology, GMP, Medical Devices, Quality System, Root Cause Analysis, GxP, Validation, Change Control, Software Documentation, Quality Control, GLP, Biopharmaceuticals, Quality Management, Regulatory Affairs, Pharmaceutical Industry, 5S, Minitab, FDA GMP, Regulatory Requirements, Computer System..., 21 CFR, GAMP, Design of Experiments, Pharmaceutics, Cleaning Validation, Supplier Quality, 21 CFR Part 11, Six Sigma, Quality Auditing, Design Control, Cross-functional Team..., ISO 14971, Manufacturing, Document Management, Technology Transfer, Aseptic Processing, Commercialization, Regulatory Submissions, DMAIC, Process Simulation, ISO
Education
Northern Illinois University 1996 — 2000
Bachelor of Science
Regulatory Compliance Associates Inc. November 2014 - Present
Rexam Healthcare January 2014 - June 2014
Rexam September 2011 - 2014
Rexam November 2008 - September 2011
Rexam Healthcare 2004 - 2008
Baxter Healthcare November 1981 - August 2003
Skills
ISO, ISO 13485, Injection Molding, Lean Manufacturing, Manufacturing, Six Sigma, Program Management, Medical Devices, Quality System, Validation, Plastics, 5S, FDA, Cross-functional Team..., Value Stream Mapping, Product Development, Operational Excellence, Root Cause Analysis, FMEA, Design Control, Extrusion, Kaizen
Education
Marquette University 1976 — 1980
BS, Biomedical Engineering
Regulatory Compliance Associates, Inc. June 2007 - Present
Young Innovations December 1999 - September 2004
Lumend January 1998 - November 1999
CR BARD 1988 - 1998
Skills
FDA, Quality System, Pharmaceutical Industry, Medical Devices, CAPA, Design Control, Quality Assurance, V&V, Leadership, Manufacturing, Validation, Cross-functional Team..., Strategic Planning, Product Development, Regulatory Filings, Quality Management, ISO 13485, Biotechnology, Six Sigma, Engineering, Project Management, Pharmaceutics, GMP, Change Management, ISO, Integration, Start-ups, Design of Experiments
Education
University of Massachusetts Lowell 1988 — 1992
BSME, Engineering
Regulatory Compliance Associates, Inc. September 2010 - Present
Motorola - Mobile Devices January 2008 - November 2009
Motorola - Mobile Devices January 2002 - December 2007
Motorola - Mobile Devices December 2000 - March 2001
Motorola - Energy System Group September 1997 - December 1999
Baxter Healthcare February 1977 - February 1997
Skills
Program Management, Change Management, Six Sigma, Document Management, Cross-functional Team..., SDLC, Quality Management, Quality Assurance, Quality System, CAPA, DMAIC, Iso 9000, Manufacturing, ISO, Software Documentation, Process Improvement, Medical Devices, Lean Manufacturing, Supply Chain, FDA, Validation, V&V, PMP, Management, Training, Testing, Change Control, Project Portfolio..., Operational Excellence
Education
Fort Hays State University 1988 — 1992
MBA, Business
Fort Hays State University 1972 — 1976
BS, Marketing
Janney's Collection January 2001 - Present
West Monroe Partners October 2012 - March 2013
Regulatory Compliance Associates, Inc. May 2008 - October 2012
Culligan International May 2005 - March 2008
SteriClean May 2002 - August 2005
Harrison Conference Center July 2001 - May 2002
Domino Amjet, Inc February 2000 - June 2001
Skills
Product Development, Sales Management, Medical Devices, Strategic Planning, Business Development, Spanish-English, Marketing Strategy, New Business Development, Process Improvement, Cross-functional Team..., Strategy, Start-ups, Account Management
Education
Universidad de las Américas, A.C. 1973 — 1977
Regulatory Compliance Associates Inc. August 2015 - Present
Oriel STAT A MATRIX March 2014 - July 2015
L2M Consulting LLC April 2011 - March 2014
Wright Medical Technology December 2008 - August 2011
Smith and Nephew May 2006 - December 2008
Baxter Healthcare March 2003 - May 2006
Baxter Healthcare 2004 - 2005
GE Medical System December 1999 - March 2003
Skills
Medical Devices, FDA, ISO 13485, Regulatory Affairs, Design Control, CAPA, Quality System, CE marking, ISO 14971, GMP, Validation, Pharmaceutical Industry, Quality Auditing, Regulatory Submissions, Regulatory Requirements, Biotechnology, Lifesciences, PMA, Sop, V&V, Change Control, Auditing, Software Documentation, Quality Assurance, Commercialization, Internal Audit, Clinical Trials, 21 CFR, Risk Assessment, 21 CFR Part 11, SOP, Life Sciences
Education
University of Wisconsin-Madison 1992 — 1996
B.S, Bachelor of Science
University of Tulsa College of Law 1996 — 1999
J.D, Juris Doctorate
Marian College of Fond du Lac 2001 — 2003
M.S.O.L.Q, Masters of Science in Organizational Leadership and Quality
Regulatory Compliance Associates Inc. February 2014 - Present
Panaridus June 2013 - December 2013
Bonkers on Main March 2010 - March 2012
MainstreetDeli LLC January 2010 - January 2012
Abbott January 1998 - September 2010
Abbott January 1998 - September 2010
Abbott January 1998 - January 2000
Abbott January 1989 - January 1998
Skills
Quality Assurance, Operations Management, Cross-functional Team..., Pharmaceutical Industry, Leadership, Manufacturing, Training, Sop, Product Development, Sales, HPLC, Forecasting, Employee Training, Process Improvement, Project Management, Team Building, Management, Strategic Planning, CAPA, GMP, Medical Devices, SOP
Education
Concordia University-Wisconsin 1994 — 2001
Bachelor of Arts (B.A.), Communication
Concordia University
B.A, Communication
Regulatory Compliance Associates Inc. June 2013 - Present
NantPharma August 2010 - March 2013
Regulatory Compliance Associates, Inc. November 2009 - August 2010
Skills
Medical Devices, Quality Assurance, Manufacturing, Engineering, Pharmaceutical Industry, Continuous Improvement, CAPA, Quality System, Quality Auditing, R&D, FDA, Leadership, Validation, ISO 13485, V&V
Education
Iowa State University 2006 — 2009
Bachelor of Science, Mechanical Engineering
College of Lake County 2004 — 2006
Regulatory Compliance Associates, Inc. June 2013 - Present
Regulatory Compliance Associates Inc. January 2001 - June 2013
Oak Grove Technologies Inc./ Quintiles 1994 - 2000
Baxter Healthcare 1980 - 1993
Skills
Medical Equipment, Medical Devices, FDA, CAPA, Design Control, ISO 13485, Quality System, V&V, Validation, GMP, Pharmaceutical Industry, Regulatory Affairs, 21 CFR Part 11, Biotechnology, Change Control, R&D, Sop, Regulatory Submissions, FMEA, Computer System..., Pharmaceutics, Regulatory Requirements, Program Management, ISO 14971, Lifesciences, Six Sigma, Quality Assurance, Cross-functional Team..., Quality Auditing, Biopharmaceuticals, GLP, Quality Control, Technology Transfer, FDA GMP, GxP, Clinical Trials, 21 CFR, Quality Management, Commercialization, DMAIC, ISO, Design of Experiments, Manufacturing Operations, Supplier Quality, Biomedical Engineering, Root Cause Analysis, Contract Manufacturing, Aseptic Processing, Cleaning Validation, Clinical Development
Education
University of Illinois at Urbana-Champaign 1973 — 1977
Engineering
University of Wisconsin
BSME, Mechanical Engineering
DePuy Synthes Institute April 2014 - Present
Independent Consultant December 2012 - April 2014
Zimmer through Black Diamond Network May 2012 - December 2012
Covidien through Black Diamond Networks February 2012 - May 2012
Regulatory Compliance Associates, Inc. November 2010 - January 2012
Boston Scientific through The Experts March 2007 - October 2010
Smiths Medical through Oxford International January 2006 - March 2007
Novartis through Spearhead Industries November 2003 - December 2005
Wyeth Pharmaceuticals (now Pfizer) through Genilogix, LLC June 2003 - September 2003
Cetan Technologies November 2000 - June 2003
Education
Harvard University
Computer Science
Regulatory Compliance Associates Inc. October 2014 - Present
Baxter August 2009 - October 2014
Catalent May 2005 - August 2009
Cardinal Health May 2005 - August 2009
CSL Behring April 1997 - May 2005
ZLB Behring April 1997 - May 2005
Centeon April 1997 - May 2005
Aventis Behring April 1997 - May 2005
Marsam Pharmaceuticals March 1994 - April 1997
Schein Pharmaceuticals March 1994 - April 1997
Skills
Validation, Pharmaceutical Industry, Aseptic Processing, GMP, FDA, CAPA
Education
University of Michigan 1989 — 1993
BSE(ME), Mechanical Engineering
Regulatory Compliance Associates Inc. August 2015 - Present
Regulatory Compliance Associates Inc. January 2013 - August 2015
Regulatory Compliance Associates Inc. May 2011 - January 2013
Skills
Lifesciences, Program Management, Medical Devices, FDA, Cross-functional Team..., Strategy, Regulatory Affairs, Pharmaceutical Industry, Biotechnology, Six Sigma, 21 CFR Part 11, Computer System..., Manufacturing, Change Control, R&D, Quality Assurance, Start-ups, CAPA, ISO 13485, Product Development, Quality System, V&V, Validation, GMP, Design Control, Regulatory Requirements, Regulatory Submissions, Pharmaceutics, Product Launch, Quality Management, Clinical Trials, Sop, Process Engineering, DMAIC, GLP, Biopharmaceuticals, Process Improvement, Continuous Improvement, Quality Auditing, SOP
Education
Georgetown University 2007 — 2011
Deerfield Academy 2003 — 2007
Bayer Healthcare, LLC January 2013 - Present
Teva Pharmaceuticals July 2010 - January 2013
Regulatory Compliance Associates, Inc. June 2009 - July 2010
Regulatory Compliance Associates, Inc. 2009 - July 2010
Baxter Healthcare February 2009 - June 2009
Hospira, Inc. September 2004 - February 2009
Hospira/Abbott 2004 - February 2009
Abbott Laboratories 2000 - 2003
Coopers-Pittman Moore 1987 - 1993
Skills
FDA, GMP, CAPA, Validation, Change Control, Quality System, Medical Devices, Pharmaceutical Industry, Regulatory Affairs, ISO 13485, V&V, Root Cause Analysis, Design Control, GxP, GLP, Computer System..., Quality Auditing, Continuous Improvement, GAMP, R&D, Aseptic Processing, Auditing, Quality Assurance, Manufacturing, Cleaning Validation, Supplier Quality, Quality Management, Compliance, Biotechnology, Regulatory Submissions, Six Sigma, ISO, Document Management, GCP, Sop, Regulatory Requirements, 21 CFR Part 11, Pharmaceutics, LIMS, Quality Control, Sterilization, Technology Transfer, ISO 14971, DMAIC, Analytical Chemistry, SOP, Sterility Assurance, FDA GMP, Trackwise, 21 CFR
Education
University of Missouri-Kansas City 1980 — 1984
Microbiology, General
Regulatory Compliance Associates Inc. November 2014 - Present
Harbor House April 2013 - October 2014
Brew Cafes April 2011 - November 2012
Skills
Statistical Data..., Data Mining, Mathematics, Statistical Modeling, Research, Combinatorics, Calculus, Microsoft Excel, Microsoft Office, PowerPoint, Customer Service, Microsoft Word, Social Media, Statistics, Facebook, Management, Time Management, Sales, Event Planning, Communication, Social Networking, Leadership, Validation, FDA, Quality Assurance
Education
Marquette University 2010 — 2014
Bachelor of Science (B.S.), Mathematics
Fresenius Kabi USA November 2012 - Present
Abbott Molecular December 2011 - November 2012
Regulatory Compliance Associates, Inc. October 2011 - December 2011
Akorn, Inc April 2011 - September 2011
Abbott Laboratories July 2006 - January 2011
Hospira May 2004 - June 2006
Abbott Labortatories September 2003 - May 2004
Baxter Healthcare December 2001 - July 2003
Baxter Healthcare September 1998 - December 2001
Baxter Healthcare December 1994 - August 1998
Skills
CAPA, GMP, Clinical Development, Medical Devices, Pharmacovigilance, Quality Assurance, NDA, Change Control, Regulatory Affairs, Clinical Research, CTD, IND, Drug Development, Global Drug Development, Pharmaceutical Industry, Pharmaceutical Research, Regulatory Submissions, Regulatory Compliance, Regulatory Documentation
Education
Roosevelt University 1997 — 2003
MS, Biotechnology and Chemical Sciences
University of Wisconsin-Stevens Point 1988 — 1992
BS, Biology
CutisPharma, Inc. May 2015 - Present
Fresenius Kabi USA March 2013 - April 2015
Pinnacle Biologics December 2011 - March 2013
Regulatory Compliance Associates Inc. November 2010 - November 2011
Hospira July 2008 - November 2010
Hospira March 2006 - July 2008
Hospira September 2004 - March 2006
Molecular Formulations, LLC January 2004 - September 2004
Advanced Life Sciences March 2001 - December 2003
Apotex Inc. August 1997 - March 2001
Skills
Pharmaceutical Industry, Strategic Planning, Quality System, Project Management, R&D, Research, Business Development, Biotechnology, Strategy, Start-ups, Biopharmaceuticals, Business Strategy, Clinical Development, Cross-functional Team..., Drug Development, Drug Discovery, Drug Testing, Entrepreneurship, FDA, GMP, Global Regulatory..., Leadership, Lifesciences, Management, Medical Devices, Oncology, Pharmaceutics, Platform Development, Process Improvement, Product Development, Product Launch, Program Management, Quality Systems Design, Regulatory Affairs, Strategic Communications, Strategic Leadership, Technology Transfer, Training, Validation, Formulation, Regulatory Submissions, GLP, Life Sciences
Education
University of Illinois at Chicago
Ph.D., Pharmaceutics/Biopharmaceutical Sciences
Lewis University
MBA, Marketing
B Sweet & Savory Bakery & Catering January 2014 - Present
Northeastern University November 2010 - January 2014
TransEnterix, Inc. September 2009 - January 2011
Regulatory Compliance Associates, Inc April 2007 - August 2008
Teleflex Medical April 2007 - August 2008
bioMerieux, Inc February 2006 - November 2006
bioMerieux, Inc February 2004 - February 2006
UNC Healthcare 2003 - 2004
UNC Healthcare 1999 - 2003
Skills
FDA, Interpersonal..., CAPA, Quality System, Quality Assurance, GMP, ISO 13485, Medical Devices, Six Sigma, Sop, Regulatory Affairs, GLP, Process Improvement, Quality Management, Quality Control, ISO, Software Documentation, Manufacturing, Minitab, Validation, Testing, 21 CFR Part 11, Design Control, Regulatory Requirements, Product Development, V&V, Lifesciences, R&D
Education
Northeastern University 2009 — 2010
MS, Regulatory Affairs for Drugs, Medical Devices and Biolgics
Winston-Salem State University 2005 — 2007
BS, Clinical Laboratory Science
MPP Consulting, LLC May 2012 - Present
Regulatory Compliance Associates Inc. 2013 - 2013
MPP Consulting, LLC November 2011 - September 2012
MPP Consulting, LLC September 2011 - November 2011
MPP Consulting, LLC June 2009 - July 2011
MPP Consulting, LLC August 2008 - April 2009
MPP Consulting, LLC April 2006 - March 2008
MPP Consulting, LLC August 2005 - April 2006
MPP Consulting, LLC January 2006 - March 2006
MPP Consulting, LLC December 2004 - July 2005
Skills
CAPA, GMP, FDA, 21 CFR Part 11, Validation, V&V, Quality Assurance, Quality System, Aseptic Processing, Change Control, Computer System..., GxP, Manufacturing, Medical Devices, Pharmaceutical Industry, Sop, Technology Transfer, Regulatory Affairs, ISO 13485, Regulatory Requirements, Quality Control, Six Sigma, Testing, Software Documentation
Education
University of North Carolina at Greensboro 1989 — 1994
Bachelor of Science (BS), Chemistry
Therapeutic Proteins International, LLC July 2015 - Present
Regulatory Compliance Associates Inc. January 2014 - July 2015
Regulatory Compliance Associates Inc. August 2013 - January 2014
Baxter Healthcare May 2012 - August 2013
Baxter Healthcare July 2011 - May 2012
Cerexa August 2010 - June 2011
Cedar Associates LLC May 2009 - August 2009
Skills
Microsoft Excel, Microbiology, Databases, Editing, PowerPoint, Microsoft Office, Microsoft Word, Project Management, Regulatory Affairs, Lifesciences, Clinical Research, Data Analysis, Validation, Regulatory Submissions, Life Sciences, FDA
Education
The Johns Hopkins University 2015 — 2017
Master’s Degree, Regulatory Science
University of Notre Dame 2007 — 2011
B.S., Biology, Minor in Philosophy
Bellarmine College Prep
Shell November 2013 - Present
Halliburton January 2012 - November 2013
Regulatory Compliance Associates, Inc. November 2011 - January 2012
Regulatory Compliance Associates, Inc. September 2010 - November 2011
Pentair Water May 2010 - September 2010
Cummins, Inc April 2009 - September 2009
Kidde Aerospace & Defense 2008 - 2008
Advanced Energy Corp. August 2007 - December 2007
Skills
Manufacturing, Finite Element Analysis, Completions, Completion, Training, Deepwater, Engineering, Analysis, Solidworks, Project Engineering, Energy, Visual Basic
Education
North Carolina State University 2005 — 2009
BS, Mechanical Engineering
Monash University, Australia 2007 — 2008
Mechanical Engineering Coursework
Pfizer June 2015 - Present
CliftonLarsonAllen January 2014 - April 2014
Regulatory Compliance Associates Inc. February 2013 - January 2014
Carthage College September 2011 - August 2013
Epopus, INC June 2010 - August 2010
Skills
Time Management, Microsoft Excel, Microsoft Office, Learning Quickly, Accounts Payable, Data Entry, Financial Accounting, Efficiency, Adaptability, Budgets, Microsoft Dynamics, SharePoint, Small Business..., Hyperion HFM, Hyperion EPM
Education
Carthage College 2011 — 2015
Bachelor of Arts (B.A.), Accounting & Spanish
Lawton High School 2007 — 2011
Regulatory Compliance Associates, Inc. January 2008 - Present
Baxter Healthcare and Fenwal, Inc. 2005 - 2007
Baxter Healthcare 2001 - 2005
Parker Hannifin 2000 - 2001
Covidien 1996 - 1999
Covidien 1991 - 1996
Baxter Healthcare June 1979 - November 1991
Skills
PMP, Problem Solving, Medical Devices, Pharmaceuticals, Stage-Gate, Quality Systems, Six Sigma, Project Portfolio..., Product Development, Program Management, PMO, Materials, Strategic Planning, Cross-functional Team..., Life Sciences, DMAIC, Team Leadership, TQM, ISO 13485, FDA, Process Engineering, Operational Excellence, Design Control, CAPA, R&D, Risk Management, Budgeting, FMEA, Pharmaceutical Industry, Quality System, Design of Experiments, Project Management, V&V, Management, ISO 14971, Engineering, Strategy, Validation, Quality Assurance, Process Improvement, Lean Manufacturing, Budgets, ISO, 21 CFR Part 11, Root Cause Analysis, Continuous Improvement, Testing, Leadership, Change Control, Injection Molding
Education
Northwestern University 1981 — 1985
Masters, Engineering Management
Northwestern University 1975 — 1979
Bachelor of Science, Chemical Engineering
Highland Park High School 1971 — 1975
Baxter International Inc. January 2013 - Present
Baxter July 2009 - December 2012
Regulatory Compliance Associates Inc 2002 - July 2009
Skills
FDA, FDA GMP, Validation, CAPA, Auditing, Field Corrective Action..., Risk Management, Project Management, ISO 13485, ISO 14971, Medical Devices, Technical Writing, Cross-functional Team..., GMP, V&V, Biomedical Engineering, Sop, Quality System, Manufacturing
Education
Mississippi State University 1998 — 2001
Master, Chemical Engineering
Beckman Coulter December 2014 - Present
Regulatory Compliance Associates Inc. March 2014 - December 2014
Johnson and Johnson MD&D February 2013 - March 2014
Life Technologies January 2011 - December 2012
Boston Scientific March 2009 - November 2010
Baxter Healthcare October 2001 - March 2009
Ford Motor Company May 1990 - October 2001
Skills
Design Control, Six Sigma, Quality System, V&V, Lean Manufacturing, Supplier Quality..., DMAIC, SPC, Reliability Engineering, Quality Assurance, Validation, Sop, Medical Devices, 21 CFR Part 11, CAPA, Supply Chain, Quality Control, GMP, Manufacturing..., FDA, Root Cause Analysis, Quality Auditing, ISO, Supplier Quality, Change Control, Operational Excellence, Value Stream Mapping, Quality Management, Design of Experiments, Reliability, 21 CFR, Cross-functional Team..., Continuous Improvement, Product Development, Manufacturing, ISO 13485, Change Management, FMEA, Leadership, ISO 14971, Process Simulation, Computer System..., Minitab, TQM, Auditing, Iso 9000, 5S, Kaizen
Education
Wayne State University
PhD, Manufacturing/Industrial
Wayne State University 1990 — 1992
MS, Manufacturing Engineering
National Institute of Technology Kurukshetra 1982 — 1987
BS, Mechanical
Northwestern University - Kellogg School of Management
Executive Education
The University of Chicago Booth School of Business
Executive Education
West Virginia State College
Creganna Medical June 2014 - Present
St. Jude Medical November 2012 - May 2014
St. Jude Medical August 2011 - November 2012
St. Jude Medical November 2010 - July 2011
Lovelace Respiratory Research Institute 2009 - 2009
Regulatory Compliance Associates, Inc. July 2006 - December 2008
Cardinal Health August 2002 - July 2006
Mentor Corporation January 2001 - August 2002
Skills
Medical Devices, V&V, Validation, ISO 13485, CAPA, FDA, Manufacturing, Sop, FMEA, Quality Assurance, ISO, GMP, ISO 14971, 21 CFR Part 11, Root Cause Analysis, DMAIC, Pharmaceutical Industry, Quality System, Minitab, Catheters, Manufacturing Operations, Pharmaceutics, Quality Control, FDA GMP, 21 CFR, Quality Auditing, Change Control, Continuous Improvement, CQA, Cross-functional Team..., Contract Manufacturing, Process Engineering, GxP, Biomedical Engineering, CE marking, Manufacturing..., Gage R&R, Supplier Quality, Process Capability, Lean Manufacturing
Education
Eastern New Mexico University 1985 — 1989
Bachelor of Science, Industrial Technology
Open to Opportunities January 2015 - Present
V & R Consulting Group January 2015 - Present
Richard Wolf Medical Instruments March 2008 - December 2014
Teleflex Medical 2006 - 2008
Regulatory Compliance Associates Inc. 2007 - 2007
V. Mueller Neuro/Spine, Cardinal Health 2001 - 2006
Cardinal Health 2000 - 2006
Baxter 1979 - 1996
Skills
Quality Systems, Surgical Instruments, Medical Devices, Quality Management, Manufacturing Management, CAPA, Quality Auditing, Design Control, FDA, GMP, QSR, 510 K, ISO 13485, Regulatory Affairs, ISO 14971, 21 CFR Part 11, CE marking, Quality Control, Aseptic Processing, 21 CFR, V&V, Manufacturing..., Computer System..., Six Sigma, Quality System, FDA GMP, Change Control, FMEA, Validation, Capital Equipment, Cross-functional Team..., Sterilization, DMAIC, Product Launch, Design of Experiments, R&D, ISO, SPC, CQA, GxP, Supplier Quality, Manufacturing, Quality Assurance, Continuous Improvement
Education
Fort Hays State University 1974 — 1980
BA, English and Business Administration
Kansas State University 1975 — 1976
Regulatory Compliance Associates Inc. June 2013 - Present
Regulatory Compliance Associates Inc. August 2009 - May 2013
Baxter 2005 - 2009
GE Healthcare 2001 - 2005
Critikon 1997 - 2001
Medtronic 1990 - 1997
Honeywell Aerospace 1985 - 1990
USAF 1981 - 1985
Skills
Medical Devices, Design Control, Leadership, Quality Assurance, Cross-functional Team..., Project Management, ISO 13485, Software Development, ISO 14971, Pharmaceutical Industry, Validation, Continuous Improvement, Program Management, CAPA, FDA, R&D, ISO, Process Improvement, Strategic Planning, Testing, Product Lifecycle..., FMEA, Manufacturing, Quality System, Embedded Systems, Quality Management, Team Leadership, GMP, Commercialization, Lean Manufacturing, Biotechnology, V&V, Engineering, Product Development, Six Sigma, Product Management, Regulatory Affairs, Operations Management, GLP, Process Engineering, Design for Manufacturing, Sop, Lifesciences, Change Control, Root Cause Analysis, DMAIC, Regulatory Submissions, Design of Experiments, Biomedical Engineering, Start-ups
Education
University of Minnesota - Carlson School of Management 1988 — 1991
MBA, Operations
University of Wisconsin-Superior 1977 — 1981
BS, math
Osseo-Fairchild High School 1974 — 1977
Larry Schadler LLC 2007 - Present
NSF International 2014 - 2014
NSF International 2014 - 2014
NSF International 2014 - 2014
Regulatory Compliance Associates, Inc. March 2010 - December 2013
US Data Management - Larry Schadler LLC January 2012 - February 2012
Luttrell Consulting Group - Larry Schadler LLC April 2011 - September 2011
Raland Technologies - Larry Schadler LLC February 2009 - April 2011
IT&E - Larry Schadler LLC February 2007 - February 2009
Lloyd's Register Serentec - Larry Schadler LLC February 2006 - February 2007
Skills
Process Validation, Validation, Computer System..., Medical Devices, 21 CFR Part 11, Compliance, Cleaning Validation, Regulatory Requirements, Quality Engineering, GxP, Quality Systems, Biotechnology, Pharmaceuticals, Quality Assurance, SOP, Software Quality..., Software Validation, CAPA, SDLC, Documentation, Remediation, cGMP, Life Sciences, FDA, LIMS, Manufacturing, Gap Analysis, GMP, Change Control, Aseptic Processing, Automation, Biopharmaceuticals, Design Control, Document Management, FDA GMP, FMEA, GLP, ISO, ISO 13485, ISO 14971, Lifesciences, Pharmaceutics, Quality Auditing, Quality Management, Quality System, Regulatory Submissions, Root Cause Analysis, Software Documentation, Technology Transfer, Testing
Education
Indiana University South Bend 1982 — 1984
MSBA, Business Administration
South Bend Medical Foundation 1975 — 1976
ASCP, Medical Technology
Michigan State University 1971 — 1975
BS, Medical Technology
Jabil November 2010 - Present
Regulatory Compliance Associates, Inc. November 2009 - June 2011
Baxter Healthcare, Inc January 2006 - August 2009
Baxter Healthcare, Inc June 2004 - August 2009
Baxter Healthcare, Inc January 1996 - January 2004
Baxter Healthcare, Inc January 1990 - January 1996
Baxter Healthcare, Inc January 1984 - January 1990
Johnson & Johnson, Inc January 1980 - January 1984
Johnson & Johnson, Inc January 1976 - January 1980
Skills
FDA, IT Management, Medical Devices, DMAIC, Product Development, CAPA, Cross-functional Team..., Engineering, Management, Quality System, Validation, Design of Experiments, Testing, Six Sigma, V&V, R&D, ISO 13485, Root Cause Analysis, Manufacturing, Quality Assurance, Design Control, Technology Management, Leadership, Quality Management, Electronics, Process Improvement, ISO 14971, Continuous Improvement, Commercialization, ISO, GMP, Lean Manufacturing, FMEA, Quality Auditing, Product Support, Biomedical Engineering, SPC, Design for Manufacturing, 21 CFR Part 11, Manufacturing..., Minitab
Education
Rensselaer Polytechnic Institute 1975 — 1976
M. Eng, Biomedical Engineering
Rensselaer Polytechnic Institute 1971 — 1975
B.S, Biomedical Engineering
Regulatory Compliance Associates, Inc. July 2009 - Present
Baxter Healthcare 2001 - June 2009
3Com Crop. 1998 - 2001
Skills
Design Control, Validation, Medical Devices, FDA, CAPA, Project Management, Cross-functional Team..., Quality System, Program Management, Pharmaceutical Industry, Quality Assurance
Education
Northern Illinois University
MBA, Business Administration
Illinois Institute of Technology
MSEE, Electrical and Computer design Engineering
Southern Illinois University, Carbondale
BSEE, Electrical Engineering
Regulatory Compliance Associates, Inc. May 2013 - Present
American Renolit Corporation LA July 2009 - Present
Maetrics 2008 - 2009
RCA Consulting 2008 - 2008
Leiner Health Products 2007 - 2007
Pharmaceutical Systems, Inc. 1994 - 2006
Skills
Quality System, Medical Devices, Validation, Manufacturing, V&V, ISO 13485, Change Control, Quality Assurance, FDA, CAPA, Quality Auditing, GMP, Process Improvement, ISO, Continuous Improvement, Six Sigma, Analysis, Sop, Cross-functional Team..., Microsoft Excel
Education
Lake Forest Graduate School of Management
Business
OpAns, LLC June 2012 - Present
OpAns, LLC February 2012 - June 2013
OpAns, LLC November 2010 - April 2012
Regulatory Compliance Associates, Inc. July 2007 - August 2008
SEC Associates October 2000 - July 2007
Aetna, INC. 1998 - 2000
Skills
Gap Analysis, Technical Analysis, 21 CFR Part 11, Validation, Sop, Software Documentation, Computer System..., GMP, GxP, Testing, Medical Devices, SDLC, V&V, Quality Management, FDA, Quality Assurance, SOP, Pharmaceutical Industry, Quality Control
Education
College of Charleston 1982 — 1986
BA, Political Science/International Studies
Regulatory Compliance Associates Inc. August 2008 - Present
Hospira Pharmaceuticals October 2005 - March 2008
GlaxoSmithKline January 1990 - March 2005
GlaxoSmithKline (GSK) 2001 - 2005
Education
University of Arizona 1973 — 1976
MS, Microbiology/Biochemistry
Regulatory Compliance Associates Inc. April 2003 - Present
Searle / Monsanto / Pharmacia 1994 - 2003
Pharmacia (formerly Searle) 1994 - 2002
Mallinckrodt Venerinary 1981 - 1994
Skills
Validation, Leadership, GxP, ERP, 21 CFR Part 11, Quality System, CAPA, Automation, Software Documentation, FMEA, Computer System..., V&V, Quality Assurance, FDA, GMP, Testing, GAMP, Cleaning Validation, Medical Devices, Lean Manufacturing, Regulatory Submissions, Pharmaceutics, Process Improvement, Quality Control, Biotechnology, Sop, Lifesciences, Process Control, FDA GMP, Regulatory Requirements, Management, ISO, Change Control, GLP, Root Cause Analysis, ISO 13485, Continuous Improvement, Pharmaceutical Industry, Document Management, Quality Auditing, R&D, Design Control, Supplier Quality, ISO 14971, Design of Experiments, 21 CFR, Calibration, Six Sigma, Quality Management, Cross-functional Team...
Education
Louisiana Tech University 1966 — 1973
BS & MS, Mechanical Engineering
Regulatory Compliance Associates, Inc. May 2013 - Present
Abbott Laboratories March 2003 - April 2012
Regulatoy Compliance Associates 2012 - 2012
Validant 2012 - 2012
Abbott Laboratories March 2003 - March 2009
Abbott Diagnostic Division January 1997 - March 2003
Abbott Diagnostics 1986 - 2000
Abbott Laboratories 1992 - 1997
Abbott Laboratories 1990 - 1992
Condell Memorial Hospital August 1977 - March 1986
Skills
CAPA, Complaint Handling, Medical Device Design..., Documentation, Document Management, Pharma GMP, Quality System..., Risk Management, Process Improvement, Process Mapping, Certified Quality..., Project Management, Training & Development, Mentoring, Performance Metrics, Visio, Minitab, Lean Six Sigma Black..., Change Control, ISO standards, ICH, Quality System, Business Process Mapping, Pharmaceutical Industry, Medical Devices, FDA, GLP, Software Documentation, Six Sigma, Complaint Management, ISO, GMP
Education
Lake Forest Graduate School of Management 1988 — 1991
MBA
DePaul University 1968 — 1972
BS, Medical Technology
Regulatory Compliance Associates, Inc. March 2012 - Present
AJR Instruments Inc. May 1992 - Present
Occamd 2010 - 2011
Baxter Healthcare June 2006 - August 2009
ConMed Linvatec 1993 - 2006
University of South Florida February 2004 - April 2005
Motorola Semiconductor 2000 - 2001
AT&T PARADYNE Corp 1988 - 1992
Paradyne 1988 - 1992
Paradyne Networks 1988 - 1992
Skills
PCB design, Pneumatics, Sensors, Schematic Capture, Hydraulics, Motors, System Design, Motor Control, Analog, Power Supplies, Microprocessors, Test Equipment, Electro-mechanical, Electronics, FPGA, Data Communication, Mixed Signal, Microcontrollers, Orcad, Digital Electronics, Signal Integrity, Embedded Systems, CPLD, Xilinx, Actuators, Hardware Design, DSP, Altium Designer, Analog Design, Power Electronics, Circuit Design, Firmware, Digital Design, Analog Circuit Design, Hardware Architecture, Integrated Circuit..., Medical Devices, Labview, Testing, R&D, Engineering, Electrical Engineering, Design Control, Device Drivers
Education
Fairleigh Dickinson University 1982 — 1983
BSEE, Electrical engineering
Oxford Global Resources April 2014 - Present
Validant July 2013 - Present
Spectranetics September 2010 - July 2013
Oxford Global Resources September 2008 - April 2011
Shire Human Genetic Therapies 2008 - 2010
Regulatory Compliance Associates, Inc 2009 - 2009
Teleflex Medical June 2006 - March 2008
Angiotech 2008 - 2008
GSK 1998 - 2006
Skills
21 CFR Part 11, Computer System..., SAP, Quality System, Change Management, ERP, Software Quality..., Test Management, System Testing, Validation, Quality Assurance, FDA, Sop, Change Control, PMP, GMP, GxP, Testing, Software Documentation, GAMP, CAPA, ISO 13485, Quality Management, Quality Auditing, V&V, LIMS, Quality Control, GLP, Medical Devices, Regulatory Requirements, Regulatory Affairs, ISO, Process Simulation, Document Management, Root Cause Analysis, SOP
Education
Colorado Christian University 1991 — 1994
BS, Organizational Management
AbbVie September 2014 - Present
AbbVie January 2013 - September 2014
Abbott Laboratories August 2010 - January 2013
Regulatory Compliance Associates, Inc. June 2010 - September 2010
Baxter July 2004 - December 2009
Baxter Healthcare November 2000 - July 2004
Baxter Healthcare May 1998 - November 2000
Baxter Healthcare November 1995 - May 1998
Jewel Food Stores Inc January 1986 - November 1995
Skills
Data Management, Quality Assurance, Document Management, Product Lifecycle..., Resource Management, Change Control, FDA, Policy Analysis, Quality System, Records Management, Validation, Sop, Regulatory Submissions, Clinical Trials, GCP, CTMS, Training, Regulatory Affairs, CAPA, GMP, ISO 13485, Continuous Improvement, Process Improvement, Medical Devices, Pharmaceutical Industry, Clinical Development, EDC, CRO, V&V, Cross-functional Team..., 21 CFR Part 11, Computer System..., GxP, Software Documentation, Regulatory Requirements, Change Management, Manufacturing, Quality Auditing, Quality Management
Education
Lake Forest Graduate School of Management 2010 — 2013
MBA, Organizational Behavior Studies
Roosevelt University 2000 — 2010
B.A., Business Administration
College of Lake County
Accounting, Business Management
PwC Consulting January 2012 - Present
Regulatory Compliance Associates, Inc. October 2010 - December 2011
Hospira July 2009 - August 2010
Hospira June 2003 - July 2009
Abbott Laboratories 1999 - 2004
Abbott Laboratories 1994 - 1999
Skills
FDA, Quality System, CAPA, Team Leadership, ISO 13485, Design Control, Medical Devices, Validation, GMP, Change Control, 21 CFR Part 11, Manufacturing, ISO 14971, Leadership, Quality Assurance, Quality Auditing, Quality Control, Quality Management, Regulatory Requirements, Root Cause Analysis, Sop, Start-ups, V, Software Documentation, Regulatory Affairs, Product Launch, Pharmaceutical Industry, ISO, Cross-functional Team..., Continuous Improvement, Biotechnology, Technology Transfer, Contract Manufacturing, Design of Experiments, Manufacturing Operations, Operational Excellence, Process Improvement
Education
University of North Carolina at Pembroke 1974 — 1976
BS, Chemistry
Regulatory Compliance Associates Inc. March 2014 - Present
Pleasant Prairie Premium Outlets May 2010 - December 2012
Aimco June 1999 - April 2001
MGS Machine January 1997 - March 1999
Skills
Accounting, Financial Reporting, Payroll Processing, Accounts Payable, Accounts Receivable, Audit, Payroll
Education
Minnesota State University, Moorhead 1990 — 1995
BS, Business/Accounting
Brainerd Senior High
Regulatory Compliance Associates, Inc. 2009 - Present
Leica Microsystems 2012 - 2012
Boston Scientific 2011 - 2011
Baxter 2006 - 2009
Baxter 2004 - 2006
Baxter 2001 - 2004
Skills
Quality Systems, Medical Devices, Manufacturing, Product Development, Compliance, Problem Solving, Design Control, ISO 13485, CAPA, Medical Device Product..., QSR, Change Control, DMAIC, Program Management, Quality Assurance, Quality Engineering, FMEA, Root Cause Analysis, R&D, PMP, GMP, Quality System, Six Sigma, Validation, Design of Experiments, Quality Control, Lean Manufacturing, Process Improvement, V&V, ISO, FDA, Pharmaceutical Industry, Cross-functional Team..., Engineering, Continuous Improvement, SPC, Quality Auditing, Process Engineering, Minitab, Supplier Quality, 21 CFR Part 11, Manufacturing Operations, Computer System..., Process Simulation, Regulatory Affairs, Sop, Regulatory Submissions, Regulatory Requirements, Project Management, Biotechnology
Education
Michigan Technological University 1983 — 1988
BS, Mechanical Engineering