Regulatory Compliance Associates Inc.

Description

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

Employee
Years
Job
Industry
Josh Lesniak Josh Lesniak Greater Chicago Area Details
Josh Lesniak's Regulatory Compliance Associates Inc. Experience February 2009 - September 2010
Job Campus Recruiter at Aon Hewitt
Industry Information Technology and Services
Experience
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

Angel Lasso Angel Lasso Tampa/St. Petersburg, Florida Area Details
Angel Lasso's Regulatory Compliance Associates Inc. Experience August 2009 - August 2011
Job Director Engineering Services at Nypro, a Jabil Company
Industry Medical Devices
Experience
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

Teresa Harrison Teresa Harrison Pleasant Prairie, Wisconsin Details
Teresa Harrison's Regulatory Compliance Associates Inc. Experience October 2014 - Present
Job Quality Specialist, Regulatory Compliance Associates, Inc.
Industry Pharmaceuticals
Experience
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

Anjali Unnikrishnan Anjali Unnikrishnan Greater Chicago Area Details
Anjali Unnikrishnan's Regulatory Compliance Associates Inc. Experience January 2015 - Present
Job Talent Manager at Regulatory Compliance Associates Inc.
Industry Staffing and Recruiting
Experience
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

Michelle Heiter Michelle Heiter Spencer, Iowa Details
Michelle Heiter's Regulatory Compliance Associates Inc. Experience August 2014 - Present
Job Consultant
Industry Pharmaceuticals
Experience
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

Doug Bullard Doug Bullard Raleigh-Durham, North Carolina Area Details
Doug Bullard's Regulatory Compliance Associates Inc. Experience February 2013 - April 2013
Job Senior Consultant of Compliance at ProPharma Group | Experience in Quality, Validation and GMP training | Author
Industry Biotechnology
Experience
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

Paul Wanback Paul Wanback Boca Raton, Florida Details
Paul Wanback's Regulatory Compliance Associates Inc. Experience October 2014 - March 2015
Job Pharmaceutical Consultant
Industry Pharmaceuticals
Experience
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

Mark Iwicki Mark Iwicki Greater Chicago Area Details
Mark Iwicki's Regulatory Compliance Associates Inc. Experience May 2009 - January 2012
Job Senior Quality Consultant
Industry Medical Devices
Experience
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

Michael Scharf Michael Scharf Greater Chicago Area Details
Michael Scharf's Regulatory Compliance Associates Inc. Experience May 2008 - June 2011
Job President & C.E.O. at Dellshire Development and Compliance Inc.
Industry Medical Devices
Experience
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

Mike Parkes Mike Parkes Greater Chicago Area Details
Mike Parkes's Regulatory Compliance Associates Inc. Experience May 2008 - Present
Job Principal at Regulatory Compliance Associates Inc
Industry Pharmaceuticals
Experience
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

Ryan Hudek Ryan Hudek Greater Chicago Area Details
Ryan Hudek's Regulatory Compliance Associates Inc. Experience March 2012 - March 2012
Job Quality Audit Compliance Manager at Mylan Institutional
Industry Pharmaceuticals
Experience
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

Susan Justice Susan Justice Greater Chicago Area Details
Susan Justice's Regulatory Compliance Associates Inc. Experience August 2010 - January 2011
Job Quality Engineer at Ethicon via Alku International
Industry Pharmaceuticals
Experience
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

Seyed Khorashahi Seyed Khorashahi Tampa/St. Petersburg, Florida Area Details
Seyed Khorashahi's Regulatory Compliance Associates Inc. Experience March 2015 - Present
Job Chief Operating Officer at Regulatory Compliance Associates Inc.
Industry Medical Devices
Experience
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

Mallory Scharf Mallory Scharf Helena, Montana Details
Mallory Scharf's Regulatory Compliance Associates Inc. Experience June 2009 - August 2009
Job Corps Member at Montana Conservation Corps
Industry Environmental Services
Experience
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

Joy Williamson, CQA Joy Williamson, CQA Phoenix, Arizona Area Details
Joy Williamson, CQA's Regulatory Compliance Associates Inc. Experience April 2005 - Present
Job Product/Process Validation Specialist at Regulatory Compliance Associates, Inc.
Industry Medical Devices
Experience
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

Kurt Attermeier Kurt Attermeier Greater Chicago Area Details
Kurt Attermeier's Regulatory Compliance Associates Inc. Experience November 2014 - Present
Job Engineering Consultant at Regulatory Compliance Associates Inc.
Industry Medical Devices
Experience
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

Brendan McCrea Brendan McCrea Greater St. Louis Area Details
Brendan McCrea's Regulatory Compliance Associates Inc. Experience June 2007 - Present
Job at RCA, Inc
Industry Medical Devices
Experience
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

Scott Soukup Scott Soukup Greater Chicago Area Details
Scott Soukup's Regulatory Compliance Associates Inc. Experience September 2010 - Present
Job Senior Quality Management System Professional
Industry Medical Devices
Experience
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 Woods Janney Woods Greater Chicago Area Details
Janney Woods's Regulatory Compliance Associates Inc. Experience May 2008 - October 2012
Job Owner, Janney's Collection (www.JanneysCollection.com)
Industry Furniture
Experience
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

Lisa Lee Michels, J.D., M.S.O.L.Q. Lisa Lee Michels, J.D., M.S.O.L.Q. Page, Arizona Details
Lisa Lee Michels, J.D., M.S.O.L.Q.'s Regulatory Compliance Associates Inc. Experience August 2015 - Present
Job Associate General Counsel and Regulatory Expert at Regulatory Compliance Associates, Inc.
Industry Medical Devices
Experience
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

Larry Bonk Larry Bonk Tucson, Arizona Area Details
Larry Bonk's Regulatory Compliance Associates Inc. Experience February 2014 - Present
Job Manufacturing/Quality Pharma Industry
Industry Pharmaceuticals
Experience
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

Jason Parkes Jason Parkes Greater Chicago Area Details
Jason Parkes's Regulatory Compliance Associates Inc. Experience June 2013 - Present
Job Engineering Consultant at Regulatory Compliance Associates Inc.
Industry Pharmaceuticals
Experience
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

Mitchell Januszewski Mitchell Januszewski Greater Chicago Area Details
Mitchell Januszewski's Regulatory Compliance Associates Inc. Experience June 2013 - Present
Job Principal and Board Member, Regulatory Compliance Associates Inc.
Industry Pharmaceuticals
Experience
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

Holli Gontz Holli Gontz Scranton, Pennsylvania Area Details
Holli Gontz's Regulatory Compliance Associates Inc. Experience November 2010 - January 2012
Job Design Quality Engineer at DePuy Synthes Institute
Industry Medical Devices
Experience
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

Ty Duginske Ty Duginske Greater Chicago Area Details
Ty Duginske's Regulatory Compliance Associates Inc. Experience October 2014 - Present
Job Director of Pharmaceuticals & Biologics at Regulatory Compliance Associates Inc.
Industry Pharmaceuticals
Experience
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

Mackenzie (Kenzie) Donovan Mackenzie (Kenzie) Donovan Greater Chicago Area Details
Mackenzie (Kenzie) Donovan's Regulatory Compliance Associates Inc. Experience August 2015 - Present
Job Director of Sales Operations at Regulatory Compliance Associates Inc.
Industry Medical Devices
Experience
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

Valerie Welter Valerie Welter St. Joseph, Missouri Area Details
Valerie Welter's Regulatory Compliance Associates Inc. Experience June 2009 - July 2010
Job Director Quality Management at Bayer Healthcare, AH Inc.
Industry Pharmaceuticals
Experience
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

Alyssa Sherman Alyssa Sherman Chicago, Illinois Details
Alyssa Sherman's Regulatory Compliance Associates Inc. Experience November 2014 - Present
Job Consultant at Regulatory Compliance Associates Inc.
Industry Pharmaceuticals
Experience
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

Julie Potter, RAC Julie Potter, RAC Greater Chicago Area Details
Julie Potter, RAC's Regulatory Compliance Associates Inc. Experience October 2011 - December 2011
Job Senior Regulatory Specialist at Fresenius Kabi
Industry Pharmaceuticals
Experience
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

Sharon Ayd Sharon Ayd Greater Boston Area Details
Sharon Ayd's Regulatory Compliance Associates Inc. Experience November 2010 - November 2011
Job Pharmaceutical and Biotechnology R&D Executive | Specialty/Branded and Generic Drugs
Industry Pharmaceuticals
Experience
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

Bobbi Hadersbeck, Owner Bobbi Hadersbeck, Owner Raleigh-Durham, North Carolina Area Details
Bobbi Hadersbeck, Owner's Regulatory Compliance Associates Inc. Experience April 2007 - August 2008
Job Independent Business Owner at B Sweet & Savory Bakery & Catering
Industry Food & Beverages
Experience
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

Mina Pathel Mina Pathel Raleigh, North Carolina Details
Mina Pathel's Regulatory Compliance Associates Inc. Experience 2013 - 2013
Job Consultant, Medical Devices & Pharmaceuticals
Industry Medical Devices
Experience
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

Jack Winnike Jack Winnike Chicago, Illinois Details
Jack Winnike's Regulatory Compliance Associates Inc. Experience January 2014 - July 2015
Job Manager, Global Regulatory Affairs at Therapeutic Proteins International, LLC
Industry Pharmaceuticals
Experience
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

Evan Hendrix Evan Hendrix Austin, Texas Details
Evan Hendrix's Regulatory Compliance Associates Inc. Experience November 2011 - January 2012
Job Wellsite Supervisor In Training at Shell
Industry Oil & Energy
Experience
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

Colleen Taplin Colleen Taplin Greater Chicago Area Details
Colleen Taplin's Regulatory Compliance Associates Inc. Experience February 2013 - January 2014
Job Financial Analyst at Pfizer
Industry Accounting
Experience
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

Larry Servi Larry Servi Greater Chicago Area Details
Larry Servi's Regulatory Compliance Associates Inc. Experience January 2008 - Present
Job Medical Products Professional
Industry Medical Devices
Experience
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

May Shia Lee May Shia Lee Greater Chicago Area Details
May Shia Lee's Regulatory Compliance Associates Inc. Experience 2002 - July 2009
Job Quality Manager at Baxter
Industry Medical Devices
Experience
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

Gopal Mohanty, PhD Gopal Mohanty, PhD Greater Los Angeles Area Details
Gopal Mohanty, PhD's Regulatory Compliance Associates Inc. Experience March 2014 - December 2014
Job Director of Quality and Regulatory at Beckman Coulter
Industry Medical Devices
Experience
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

Joy Taylor Joy Taylor Greater Minneapolis-St. Paul Area Details
Joy Taylor's Regulatory Compliance Associates Inc. Experience July 2006 - December 2008
Job Sr. Quality Engineer at Creganna Medical
Industry Medical Devices
Experience
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

Ron Haselhorst Ron Haselhorst Greater Chicago Area Details
Ron Haselhorst's Regulatory Compliance Associates Inc. Experience 2007 - 2007
Job Senior Regulatory and Quality Professsional
Industry Medical Devices
Experience
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

Brian Matye Brian Matye Tampa/St. Petersburg, Florida Area Details
Brian Matye's Regulatory Compliance Associates Inc. Experience June 2013 - Present
Job Chief Executive Officer at Regulatory Compliance Associates Inc.
Industry Medical Devices
Experience
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 Larry Schadler Benton Harbor, Michigan Area Details
Larry Schadler's Regulatory Compliance Associates Inc. Experience March 2010 - December 2013
Job Consultant at Larry Schadler LLC
Industry Pharmaceuticals
Experience
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

Thomas Hartranft, M.Eng. Thomas Hartranft, M.Eng. Tampa/St. Petersburg, Florida Area Details
Thomas Hartranft, M.Eng.'s Regulatory Compliance Associates Inc. Experience November 2009 - June 2011
Job Sr. Director, Design Services at Jabil
Industry Medical Devices
Experience
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

Sam Koniali Sam Koniali Greater Chicago Area Details
Sam Koniali's Regulatory Compliance Associates Inc. Experience July 2009 - Present
Job Experienced Sr. Engineering & Program Manager (PMP)
Industry Medical Devices
Experience
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

Mary Moriva Mary Moriva Greater Chicago Area Details
Mary Moriva's Regulatory Compliance Associates Inc. Experience May 2013 - Present
Job Executive Quality Consultant at Regulatory Compliance Associates, Inc.
Industry Pharmaceuticals
Experience
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

Cynthia Hale Cynthia Hale Raleigh-Durham, North Carolina Area Details
Cynthia Hale's Regulatory Compliance Associates Inc. Experience July 2007 - August 2008
Job Quality Assurance Manager at OpAns, LLC
Industry Pharmaceuticals
Experience
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

Stephen Plating Stephen Plating Greenville, South Carolina Area Details
Stephen Plating's Regulatory Compliance Associates Inc. Experience August 2008 - Present
Job Consulting Specialist at Regulatory Compliance Associates Inc.
Industry Pharmaceuticals
Experience
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

Stan Ward Stan Ward Greater Chicago Area Details
Stan Ward's Regulatory Compliance Associates Inc. Experience April 2003 - Present
Job Sr. Director, Automated Systems Validation at Regulatory Compliance Associates Inc.
Industry Pharmaceuticals
Experience
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

Joan Ward Joan Ward Greater Chicago Area Details
Joan Ward's Regulatory Compliance Associates Inc. Experience May 2013 - Present
Job Quality Subject Matter Expert/consultant at Regulatory Compliance Associates, Inc.
Industry Medical Devices
Experience
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

Gideon Hecht Gideon Hecht Tampa/St. Petersburg, Florida Area Details
Gideon Hecht's Regulatory Compliance Associates Inc. Experience March 2012 - Present
Job Electrical, software, and system Engineer
Industry Health, Wellness and Fitness
Experience
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

Patricia Garner Patricia Garner Indianapolis, Indiana Area Details
Patricia Garner's Regulatory Compliance Associates Inc. Experience 2009 - 2009
Job Consultant Senior CSV Lead at Oxford Global Resources
Industry Information Technology and Services
Experience
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

Lori Davis, MBA Lori Davis, MBA Greater Chicago Area Details
Lori Davis, MBA's Regulatory Compliance Associates Inc. Experience June 2010 - September 2010
Job Assistant Director, Quality Systems Pharmacovigilance System and Compliance at AbbVie
Industry Hospital & Health Care
Experience
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

Bernie Ellers Bernie Ellers Sarasota, Florida Area Details
Bernie Ellers's Regulatory Compliance Associates Inc. Experience October 2010 - December 2011
Job Management Consultant Quality Systems
Industry Medical Devices
Experience
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

Shereen Theisen Shereen Theisen Greater Chicago Area Details
Shereen Theisen's Regulatory Compliance Associates Inc. Experience March 2014 - Present
Job Accountant at Regulatory Compliance Associates Inc.
Industry Accounting
Experience
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

Jeff Packard Jeff Packard Greater Chicago Area Details
Jeff Packard's Regulatory Compliance Associates Inc. Experience 2009 - Present
Job Sr. Program Manager at Regulatory Compliance Associates, Inc.
Industry Hospital & Health Care
Experience
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