QualComp Consulting Services
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QualComp Consulting Services Employees
QualComp Consulting Services January 2014 - April 2014
QualComp Consulting Services June 2013 - October 2013
Merck May 2008 - December 2012
Organon September 2004 - May 2008
Organon February 2002 - September 2004
Organon June 2001 - February 2002
LTS - Lohmann Therapy Systems September 1999 - June 2001
Lamart Corporation February 1998 - September 1999
Web-Cote Ind.Inc., April 1992 - February 1998
Woodwork Enterprises January 1988 - October 1990
Skills
Sterile Manuf., LOC Manuf., Transdermal Manuf., Solid Dosage Manuf., Clean Rooms, Sanitization, BMS, Aseptic Intervention, Batch Record Review, SOP Review, Supervision, Quality Control, cGMP, QA Auditing, Process Improvement, Vendor Management, Trackwise, LIMS, SAP, QAS, BTS, Converting and Web..., Gamma Gauge Inline..., Metalwork Manufacturing, Machining, GMP, Reviews, Quality Assurance
Education
Montclair State University 2003 — 2005
Technical/Mechanical School, Sanok, Poland 1976 — 1981
Diploma
Maquet Getinge Group June 2014 - Present
QualComp Consulting Services April 2014 - June 2014
Massachusetts General Hospital - Harris Orthopaedics Lab (HOL) June 2013 - August 2013
Bristol-Myers Squibb - Clinical Supply Operations - Manufacturing June 2012 - August 2012
NYU Langone Medical Center - Rusk Institute June 2010 - August 2010
Rutgers University - Industrial Engineering Department July 2008 - August 2008
The Cancer Institute of New Jersey - Robert Wood Johnson Medical Center July 2007 - August 2007
Skills
Public Speaking, PCR, Biomechanics, Pharmaceutical Industry, Manufacturing, Management, Conflict Resolution, Cell Culture, Matlab, Solidworks, Laboratory Skills, Six Sigma, Continuous Improvement, Gel Electrophoresis, Microsoft Applications, Orthopaedics, OpenSim, Polymer Science, Abaqus FEA, Labview, Minitab, Product Innovation, LabVIEW, Process Improvement, Medical Devices, Product Complaints, Microsoft Excel
Education
Rensselaer Polytechnic Institute 2009 — 2013
Bachelor of Science (BS), Biomedical Engineering
Watchung Hills Regional High School
QualComp Consulting Services August 2014 - Present
PVH Corp. January 2014 - July 2014
SSATB August 2010 - February 2013
Source4Teachers March 2008 - May 2011
United States Postal Service October 2007 - September 2008
Skills
Public Speaking, Microsoft Office, Event Planning, Microsoft Excel, Customer Service, PowerPoint, Research, Microsoft Word, Social Media, Outlook, Social Networking, Editing, Community Outreach, Nonprofits, Higher Education, Management, Fundraising
Education
Rutgers University-New Brunswick 2001 — 2008
Bachelor of Science (B.S.), Kinesiology and Exercise Science
Rutgers, The State University of New Jersey-New Brunswick 2001 — 2008
Bachelor of Science (BS), Exercise Science
Amicus Therapeutics September 2015 - Present
QualComp Consulting Services June 2014 - July 2015
Novo Nordisk October 2013 - December 2013
Johnson & Johnson September 2012 - October 2013
Novo Nordisk August 2010 - September 2012
Citi July 2006 - February 2007
Randstad on site at Merrill Lynch February 2006 - June 2006
Skills
Applicant Tracking..., New Hire Orientations, Taleo, Onboarding, Human Resources, Employee Relations, Recruiting, PeopleSoft, Microsoft Office, Full-life Cycle..., Strategic Sourcing, Background Checks, E-Verify, New Hire Processes, Third Party Vendors, Event Planning, Diversity Planning, Union Experience, Kenexa, Electronic I-9, Employee Referral..., Medical Devices, Non-disclosure..., Contract Negotiation, Consent Decree, Talent Management, Management, Talent Acquisition, Temporary Placement
Education
Howard University 2001 — 2005
Business Management, Management, Human Resources, and Labor Relations
Franklin HighSchool
Moody's Analytics June 2015 - August 2015
PSEG May 2014 - May 2015
QualComp Consulting Services October 2013 - May 2014
Best Buy August 2013 - March 2014
Geek Squad April 2012 - September 2013
Skills
Microsoft Office, Computer Hardware, Microsoft Word, Customer Service, Computer Repair, Microsoft Excel, OS X, Networking, Programming, Computers, PowerPoint, Windows, Hardware, Java, Troux, SharePoint, Active Directory, Eclipse, SQL
Education
Montclair State University 2012 — 2016
Bachelor's Degree, Computer Science
Academy for Information Technology 2008 — 2012
High School, Information Technology
GSK November 2014 - Present
Novartis Consumer Health November 2014 - Present
Novartis Consumer Health May 2013 - October 2014
QualComp Consulting Services April 2013 - May 2013
Merck April 2000 - December 2012
Enzon Pharmaceuticals August 1998 - April 2000
Skills
CAPA, GMP, FDA, GxP, Six Sigma, Change Control, Sop, Validation, 21 CFR Part 11, LIMS, Trackwise, Quality Assurance, Quality System, Process Improvement, Continuous Improvement, Aseptic Processing, V&V, Pharmaceutical Industry, ISO, Cleaning Validation, GLP, Quality Control, GAMP, Regulatory Affairs, Technology Transfer, Quality Auditing, FDA GMP
Education
Stevens Institute of Technology
MS, Technology Management
Monmouth University
BS, Biology
QualComp Consulting Services September 2014 - Present
Drexel University April 2013 - June 2014
Vapotherm September 2013 - March 2014
Drexel University February 2013 - December 2013
Philips June 2013 - September 2013
Defence Research and Development Organisation July 2011 - August 2012
Emtech Foundation January 2011 - March 2011
Soft Imaging and Medical Solutions June 2010 - August 2010
Defence Research and Development Organisation June 2009 - July 2009
Skills
Biomedical Engineering, Matlab, Medical Devices, Signal Processing, FDA, Embedded Systems, Quality Assurance, C, Image Processing, Regulatory Affairs, ISO 13485, C++, Simulations, Programming, Biomaterials, Cell Culture, Biomechanics, Mathematical Modeling, Medical Imaging, Microscopy, Solidworks, ECG interpretation, Data Analysis, Simulink, R&D, Clinical Trials, Medical Instrumentation, IRB approval, Rehabilitation..., Orthotics, Validation, Quality System, Minitab, Cross-functional Team..., SolidWorks
Education
Drexel University 2012 — 2014
Master of Science (M.S.), Biomedical Engineering, 3.71/4
Maharshi Dayanand University 2007 — 2011
Bachelor of Engineering (B.E.), Biomedical Engineering
Certified Yoga Instructor April 2014 - Present
MAETRICS September 2014 - January 2015
MAETRICS October 2012 - March 2014
Oxford Global Resources May 2012 - October 2012
QualComp Consulting Services May 2012 - July 2012
Validant September 2011 - May 2012
Rio Salado College February 2010 - July 2010
Virtual Goody Bags, L.L.C. May 2010 - May 2010
Edward Jones October 2009 - May 2010
W.L. Gore & Associates October 2006 - June 2009
Skills
Event Planning, Event Management, Training, Educational Technology, Adult Education, Elementary Education, Quality Assurance, Regulatory Submissions, International..., MDRs, Vigilance
Education
Arizona State University 2010 — 2011
M.A., Language & Literacy, 4.0
Arizona State University 2001 — 2003
B.A., Elementary Education and Teaching
QualComp Consulting Services April 2014 - Present
Verizon Wireless November 2012 - March 2014
Stereotaxis July 2011 - November 2012
Accellent January 2010 - June 2011
Spartech Corporation 2008 - 2009
Computerized Medical Systems, Inc. 2003 - 2008
Guardian Industries 2001 - 2003
Anheuser-Busch 1989 - 2000
Procter & Gamble 1984 - 1989
Skills
Quality System, Medical Devices, ISO 13485, FDA, Quality Assurance, Validation, CAPA, Manufacturing Operations, Packaging, Start-ups, ISO, Quality Management, Continuous Improvement, Design Control, Regulatory Affairs, Cross-functional Team..., Root Cause Analysis, V&V, Quality Auditing, Leadership, GMP, Lean Manufacturing, Process Simulation, DMAIC, Software, Six Sigma
Education
Saint Louis University 1997 — 2005
MBA, Operations / Supply Chain Mgnt
University of Missouri-Rolla
BS, Chemical Engineering
Barnhill & Associates, Inc. December 2003 - Present
Marion Weinreb & Associates, Inc. December 2005 - Present
Smart Consulting Group, LLC March 2015 - March 2015
Jay@barnhillassociates.net July 2014 - March 2015
Compliance Architects® February 2014 - June 2014
QualComp Consulting Services April 2012 - February 2014
Compliance Architects® May 2011 - December 2011
Steris Laboratories, Inc 2003 - 2004
Andrx Pharmaceuticals, Inc 2003 - 2003
DSM Pharmaceuticals 2000 - 2003
Skills
Strategic Planning, Cleaning Validation, Aseptic Processing, Chromatography, Customer Service, Six Sigma, Product Development, Chemistry, GMP, Software Documentation, analytical chemistry, audit, batch record, environmental monitoring, Root Cause Analysis, Root Cause Problem..., HPLC, Dissolution, Change Control, Deviation Management, Project Management, Quality Assurance, Quality System..., GDP, GLP, LIMS, Lean Thinking, Biologics, Pharmaceutical..., Pharmaceutical Sciences, Pharmaceutical..., Medical Devices, Process Improvement, Failure Analysis, Investigation, Fishbone, 5 Why, Pharmaceutical Packaging, Interpreting Data, Laboratory, Process Validation, Analytical Method..., TrackWise, Compliance, Equipment Qualification, Technical Transfers, Parenteral, Vaccines, Consulting, Technical Writing
Education
Barton College
Bachelor’s Degree, Cell Biology
Carling Communications August 2015 - Present
QualComp Consulting Services April 2013 - August 2015
SAIC June 2011 - April 2013
ViaSat January 2011 - June 2011
SAIC 2009 - 2011
BAE Systems August 2008 - September 2009
Science Applications International Corporation November 2007 - August 2008
Science Applications International Corporation June 2005 - October 2007
Skills
Financial Analysis, FAR, Financial Reporting, Auditing, Costpoint, Government Contracting, Accounting, Sarbanes-Oxley Act, GAAP, SAP, CAS Compliance, Cost Accounting..., Oracle 11i, Revenue Recognition, Internal Controls, Hyperion Enterprise, Financial Accounting, Finance, Analysis, Managerial Finance, General Ledger, Variance Analysis, Account Reconciliation, Accruals, Financial Audits, Internal Audit, Cost Benefit, Deltek, Financial Forecasting, Process Improvement, Budgets, Mergers & Acquisitions, Cost Accounting, Payroll, Business Process, Access, Invoicing
Education
San Diego State University-California State University
Bachelor's degree, Accounting