ValSource, LLC
Description
Address: 918 Horseshoe Pike, Downingtown, PA 19335 Phone: (610) 269-2808Place name: Website: : : : : : : Hours: Category: Website: http://www.valsource.com/ Category: Professional Services 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. · Own this business?Add missing informationAdd business hours 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 Val Source Posting publicly on the Web Write a review Reviews Be the first to review
ValSource, LLC List of Employees There's an exhaustive list of past and present employees! Get comprehensive information on the number of employees at ValSource, LLC. You can filter them based on skills, years of employment, job, education, department, and prior employment.
ValSource, LLC Salaries. You can even request information on how much does ValSource, LLC pay if you want to. Learn about salaries, pros and cons of working for ValSource, LLC directly from the past employees.
Find People by Employers You can rekindle an old relationship, reconnect with a long-lost friend, former boss, business acquaintance who might be useful in your new line of work. With our employee database, the possibilities are endless. All you have to do is type in a couple of keywords and we'll bring you the exact information you wanted!
83 ValSource, LLC employees in database. Find out everything there's to know about ValSource, LLC employees. We offer you a great deal of unbiased information from the internal database, personal records, and many other details that might be of interest to you.
ValSource, LLC Employees
Employee
Years
Job
Industry
Andrew Chamblin Andrew Chamblin's ValSource, LLC Experience June 2014 - Present
Job Southeast Regional Manager at ValSource, LLC
Industry
Experience
ValSource, LLC June 2014 - Present
Skills
Validation, Process Validation, Project Management, Risk Assessment, Commissioning, Lyophilization
Education
Salisbury University
Bachelor's Degree, Biology: Minor, Chemistry
ValSource, LLC June 2014 - Present
Skills
Validation, Process Validation, Project Management, Risk Assessment, Commissioning, Lyophilization
Education
Salisbury University
Bachelor's Degree, Biology: Minor, Chemistry
Jhamel Williams Jhamel Williams's ValSource, LLC Experience June 2006 - May 2009
Job Senior Lead Validation Engineer at VALSPEC
Industry Pharmaceuticals
Experience
VALSPEC January 2014 - Present
Bristol-Myers Squibb October 2012 - December 2013
Merck May 2009 - October 2012
ValSource, LLC June 2006 - May 2009
Skills
Microsoft Office, Microsoft Excel, Microsoft Word, Customer Service, PowerPoint, English, Windows, Research, Outlook, Public Speaking, Automation, Change Control, Testing, Validation, Troubleshooting, 21 CFR Part 11, Biotechnology, CAPA, FDA, Manufacturing, PLC, Pharmaceutical Industry, SOP
Education
Campbell University 2000 — 2005
Bachelor of Science (BS), Pharmaceutical Sciences
VALSPEC January 2014 - Present
Bristol-Myers Squibb October 2012 - December 2013
Merck May 2009 - October 2012
ValSource, LLC June 2006 - May 2009
Skills
Microsoft Office, Microsoft Excel, Microsoft Word, Customer Service, PowerPoint, English, Windows, Research, Outlook, Public Speaking, Automation, Change Control, Testing, Validation, Troubleshooting, 21 CFR Part 11, Biotechnology, CAPA, FDA, Manufacturing, PLC, Pharmaceutical Industry, SOP
Education
Campbell University 2000 — 2005
Bachelor of Science (BS), Pharmaceutical Sciences
Matt Hausman Matt Hausman's ValSource, LLC Experience November 2014 - Present
Job Validation Consultant at ValSource, LLC
Industry Political Organization
Experience
ValSource, LLC November 2014 - Present
Forked River Butcher Shop March 2012 - November 2014
Federal Trade Commission 2013 - 2013
Skills
Microsoft Office, Customer Service, Microsoft Word, Research, PowerPoint, Public Speaking, Social Media, English, Teamwork
Education
Stockton University 2010 — 2013
Bachelor of Arts (B.A.), Political Science
ValSource, LLC November 2014 - Present
Forked River Butcher Shop March 2012 - November 2014
Federal Trade Commission 2013 - 2013
Skills
Microsoft Office, Customer Service, Microsoft Word, Research, PowerPoint, Public Speaking, Social Media, English, Teamwork
Education
Stockton University 2010 — 2013
Bachelor of Arts (B.A.), Political Science
Matt Lambert Matt Lambert's ValSource, LLC Experience February 2010 - March 2011
Job Validation Engineer at Argos Therapeutics
Industry Biotechnology
Experience
Argos Therapeutics April 2015 - Present
Independent Validation Professional 2007 - Present
NNE Pharmaplan October 2013 - October 2014
ValSource, LLC February 2010 - March 2011
KBR, Inc. (formerly BE&K BioPharm) June 2007 - February 2009
PerkinElmer 2005 - 2006
Microbac Laboratories, Inc. (formerly Southern Testing & Research Labs) August 2000 - October 2004
Skills
Analytical Chemistry, 21 CFR Part 11, Validation, HPLC, Gas Chromatography, TOC, Commissioning, Laboratory Equipment, GMP, Sop, Change Control, FDA, LIMS, V&V, Pharmaceutical Industry, OOS, Water for Injection, Ion Chromatography, Chromatography Data..., UV/Vis, APIs, HEPA Filtration, Quality Assurance, Temperature Mapping, Clean Rooms, Biotechnology, Solid Oral Dosage Forms, Purified Water, User Requirements, IQ/OQ/PQ, CAPA, P&ID, Autoclave, Wet Chemistry, Kaye Validator, Compliance Remediation, Computer System..., Aseptic Processing, Quality Control, Chemistry, USP, Sterilization, Chromatography, Laboratory, GxP, Calibration, Parenteral, Dissolution, Analytical Method..., Technology Transfer
Education
University of Central Oklahoma 1995 — 1999
B.S., Forensic Science
Northern Oklahoma College 1993 — 1996
A.A., Social Science
Perry H.S.
Perry H.S.
Argos Therapeutics April 2015 - Present
Independent Validation Professional 2007 - Present
NNE Pharmaplan October 2013 - October 2014
ValSource, LLC February 2010 - March 2011
KBR, Inc. (formerly BE&K BioPharm) June 2007 - February 2009
PerkinElmer 2005 - 2006
Microbac Laboratories, Inc. (formerly Southern Testing & Research Labs) August 2000 - October 2004
Skills
Analytical Chemistry, 21 CFR Part 11, Validation, HPLC, Gas Chromatography, TOC, Commissioning, Laboratory Equipment, GMP, Sop, Change Control, FDA, LIMS, V&V, Pharmaceutical Industry, OOS, Water for Injection, Ion Chromatography, Chromatography Data..., UV/Vis, APIs, HEPA Filtration, Quality Assurance, Temperature Mapping, Clean Rooms, Biotechnology, Solid Oral Dosage Forms, Purified Water, User Requirements, IQ/OQ/PQ, CAPA, P&ID, Autoclave, Wet Chemistry, Kaye Validator, Compliance Remediation, Computer System..., Aseptic Processing, Quality Control, Chemistry, USP, Sterilization, Chromatography, Laboratory, GxP, Calibration, Parenteral, Dissolution, Analytical Method..., Technology Transfer
Education
University of Central Oklahoma 1995 — 1999
B.S., Forensic Science
Northern Oklahoma College 1993 — 1996
A.A., Social Science
Perry H.S.
Perry H.S.
Devin Donahue Devin Donahue's ValSource, LLC Experience October 2011 - May 2015
Job Validation Engineer II at Acorda Therapeutics
Industry Biotechnology
Experience
Acorda Therapeutics, Inc. May 2015 - Present
ValSource, LLC October 2011 - May 2015
Institute for Healthcare Improvement - NCSU Chapter May 2011 - December 2012
WakeMed September 2008 - March 2010
Sigma Phi Epsilon - NC Beta February 2007 - August 2009
Skills
Bio-manufacturing..., Emergency Medical..., Biotechnology, Microsoft Office, PowerPoint, Microsoft Excel, Microsoft Word, Research, Data Analysis, Validation, Process Improvement, Leadership, Teamwork, Customer Service, Public Speaking, Marketing, SDS-PAGE, Community Outreach, GMP, Pharmaceutical Industry, Team Leadership, SOP, FDA
Education
North Carolina State University 2011 — 2012
Master of Nutrition - Professional Science Master, Human Nutrition
North Carolina State University 2006 — 2011
B.S. Nutrition Science, Minors in: Biomanufacturing Engineering, Psychology
Acorda Therapeutics, Inc. May 2015 - Present
ValSource, LLC October 2011 - May 2015
Institute for Healthcare Improvement - NCSU Chapter May 2011 - December 2012
WakeMed September 2008 - March 2010
Sigma Phi Epsilon - NC Beta February 2007 - August 2009
Skills
Bio-manufacturing..., Emergency Medical..., Biotechnology, Microsoft Office, PowerPoint, Microsoft Excel, Microsoft Word, Research, Data Analysis, Validation, Process Improvement, Leadership, Teamwork, Customer Service, Public Speaking, Marketing, SDS-PAGE, Community Outreach, GMP, Pharmaceutical Industry, Team Leadership, SOP, FDA
Education
North Carolina State University 2011 — 2012
Master of Nutrition - Professional Science Master, Human Nutrition
North Carolina State University 2006 — 2011
B.S. Nutrition Science, Minors in: Biomanufacturing Engineering, Psychology
Oswaldo Molina Oswaldo Molina's ValSource, LLC Experience February 2013 - Present
Job Validation Engineer at Valsource
Industry Pharmaceuticals
Experience
ValSource, LLC February 2013 - Present
Kaiser Aluminum June 2012 - February 2013
Unified Grocers June 2007 - February 2012
Skills
Purchasing, Inventory Management, Frozen Food, Negotiation, Supply Chain Management, Cross-functional Team..., Manufacturing, Process Improvement, Team Building, Leadership, Sourcing, Lean Manufacturing, Product Development, Team Leadership, Training, Management, Change Management, Sales Operations, Project Planning, Contract Negotiation, Project Management, Key Account Management, New Business Development, Sales Management, GMP, Food, Cleaning Validation, Automation, Validation
Education
California State Polytechnic University-Pomona
Bachelor of Science (BS), Chemical Engineering
ValSource, LLC February 2013 - Present
Kaiser Aluminum June 2012 - February 2013
Unified Grocers June 2007 - February 2012
Skills
Purchasing, Inventory Management, Frozen Food, Negotiation, Supply Chain Management, Cross-functional Team..., Manufacturing, Process Improvement, Team Building, Leadership, Sourcing, Lean Manufacturing, Product Development, Team Leadership, Training, Management, Change Management, Sales Operations, Project Planning, Contract Negotiation, Project Management, Key Account Management, New Business Development, Sales Management, GMP, Food, Cleaning Validation, Automation, Validation
Education
California State Polytechnic University-Pomona
Bachelor of Science (BS), Chemical Engineering
Michael Bolinsky Michael Bolinsky's ValSource, LLC Experience March 2003 - November 2005
Job Quality Technical Transfer Manager at Sharp Corporation (dba Sharp Packaging Solutions)
Industry Pharmaceuticals
Experience
Sharp Corporation (dba Sharp Packaging Solutions) June 2013 - Present
Sharp Corporation (dba Sharp Packaging Solutions) December 2010 - May 2013
Hyde Engineering + Consulting June 2008 - May 2010
Merck December 2005 - December 2007
ValSource, LLC March 2003 - November 2005
Elan Pharmaceuticals October 2000 - September 2002
Air Products March 1998 - September 2000
Air Products October 1995 - February 1998
Silberline October 1993 - September 1995
Silberline October 1989 - September 1993
Skills
Product Development, Microsoft Office, Six Sigma, Software Documentation, Validation, Microsoft Excel, Manufacturing, Process Improvement, Quality Assurance, SAP, Engineering, Continuous Improvement, Lean Manufacturing, Process Engineering, Quality System, Procurement, GMP, FDA
Education
Lehigh University 1988 — 1993
Master of Science (MS), Chemical Engineering
Penn State University 1980 — 1984
Bachelor's Degree, Chemical Engineering
Sharp Corporation (dba Sharp Packaging Solutions) June 2013 - Present
Sharp Corporation (dba Sharp Packaging Solutions) December 2010 - May 2013
Hyde Engineering + Consulting June 2008 - May 2010
Merck December 2005 - December 2007
ValSource, LLC March 2003 - November 2005
Elan Pharmaceuticals October 2000 - September 2002
Air Products March 1998 - September 2000
Air Products October 1995 - February 1998
Silberline October 1993 - September 1995
Silberline October 1989 - September 1993
Skills
Product Development, Microsoft Office, Six Sigma, Software Documentation, Validation, Microsoft Excel, Manufacturing, Process Improvement, Quality Assurance, SAP, Engineering, Continuous Improvement, Lean Manufacturing, Process Engineering, Quality System, Procurement, GMP, FDA
Education
Lehigh University 1988 — 1993
Master of Science (MS), Chemical Engineering
Penn State University 1980 — 1984
Bachelor's Degree, Chemical Engineering
Scott Ruch's ValSource, LLC Experience April 2009 - August 2014
Job Senior Cleaning Validation Associate
Industry Pharmaceuticals
Experience
Lannett Company August 2014 - Present
ValSource, LLC April 2009 - August 2014
DPT Laboratories January 2002 - April 2009
Skills
Cleaning Validation, Sterilization, Commissioning, IQ/OQ, Root Cause Analysis, Process Validation, Packaging Validation, 21 CFR Part 11, Aseptic Processing, CAPA, Change Control, GAMP, GMP, GxP, Sop, V, Validation
Education
Richard Stockton College of New Jersey 1997 — 2001
Bachelor of Science (BS), Chemistry
Lannett Company August 2014 - Present
ValSource, LLC April 2009 - August 2014
DPT Laboratories January 2002 - April 2009
Skills
Cleaning Validation, Sterilization, Commissioning, IQ/OQ, Root Cause Analysis, Process Validation, Packaging Validation, 21 CFR Part 11, Aseptic Processing, CAPA, Change Control, GAMP, GMP, GxP, Sop, V, Validation
Education
Richard Stockton College of New Jersey 1997 — 2001
Bachelor of Science (BS), Chemistry
Jomar Camacho Jomar Camacho's ValSource, LLC Experience June 2010 - Present
Job Validation Specialist en ValSource, LLC
Industry Pharmaceuticals
Experience
ValSource, LLC June 2010 - Present
Education
University of Puerto Rico-Mayaguez 2002 — 2008
Bachelor's degree, Civil Engineering
ValSource, LLC June 2010 - Present
Education
University of Puerto Rico-Mayaguez 2002 — 2008
Bachelor's degree, Civil Engineering
Lanelle Dort Lanelle Dort's ValSource, LLC Experience September 2007 - November 2010
Job Sr QA Specialist at Elanco
Industry Pharmaceuticals
Experience
Elanco January 2015 - Present
DPT Laboratories September 2011 - October 2012
ValSource, LLC September 2007 - November 2010
Biomimetic Therapeutics 2007 - 2008
Emerging Leader in the Development and Commercialization of Drug-Device Combination Products 2005 - 2007
ImClone Systems 2005 - 2007
Skills
Quality Assurance, GMP, Cleaning Validation, Validation, Pharmaceutical Industry, Change Control, Sop, GxP, Lifesciences, Aseptic Processing, Biotechnology, CAPA, FDA, 21 CFR Part 11, GLP, Quality System, Regulatory Affairs, Biopharmaceuticals, SOP
Education
Kean University 2000 — 2004
Kean University
Elanco January 2015 - Present
DPT Laboratories September 2011 - October 2012
ValSource, LLC September 2007 - November 2010
Biomimetic Therapeutics 2007 - 2008
Emerging Leader in the Development and Commercialization of Drug-Device Combination Products 2005 - 2007
ImClone Systems 2005 - 2007
Skills
Quality Assurance, GMP, Cleaning Validation, Validation, Pharmaceutical Industry, Change Control, Sop, GxP, Lifesciences, Aseptic Processing, Biotechnology, CAPA, FDA, 21 CFR Part 11, GLP, Quality System, Regulatory Affairs, Biopharmaceuticals, SOP
Education
Kean University 2000 — 2004
Kean University
Brian Bascom Brian Bascom's ValSource, LLC Experience August 2014 - March 2015
Job Aerospace Engineer at GKN Aerospace
Industry Mechanical or Industrial Engineering
Experience
GKN Aerospace March 2015 - Present
ValSource, LLC August 2014 - March 2015
Skills
Matlab, ProEngineer Wildfire, Strong Presentation..., Critical Problem Solving, Critical Thinking, Microsoft Office, Microsoft Excel, Results Driven..., Strong Interpersonal..., Communication, ANSYS ICEM, Pointwise, CFD Fluent, Leadership, PowerPoint
Education
Syracuse University 2010 — 2014
Bachelor of Science (BS), Aerospace, Aeronautical and Astronautical Engineering
Syracuse University 2010 — 2014
GKN Aerospace March 2015 - Present
ValSource, LLC August 2014 - March 2015
Skills
Matlab, ProEngineer Wildfire, Strong Presentation..., Critical Problem Solving, Critical Thinking, Microsoft Office, Microsoft Excel, Results Driven..., Strong Interpersonal..., Communication, ANSYS ICEM, Pointwise, CFD Fluent, Leadership, PowerPoint
Education
Syracuse University 2010 — 2014
Bachelor of Science (BS), Aerospace, Aeronautical and Astronautical Engineering
Syracuse University 2010 — 2014
Walter Henkels Walter Henkels's ValSource, LLC Experience June 2000 - Present
Job Sr. Consultant at ConcordiaValSource
Industry Pharmaceuticals
Experience
ConcordiaValSource 2011 - Present
ValSource, LLC June 2000 - Present
Avax Technologies 2000 - 2001
SmithKline Beecham 1993 - 2000
McNeil Consumer & Specialty Pharmaceuticals 1993 - 1993
Procter and Gamble 1992 - 1993
Skills
Validation, Sop, Change Control, 21 CFR Part 11, Computer System..., GxP, GMP, GAMP, V&V, FDA, CAPA, Pharmaceutical Industry, Biopharmaceuticals, Technology Transfer, LIMS, Biotechnology, Quality System, GLP, Quality Assurance, Process Simulation, ISO 13485, Vaccines, Trackwise, Aseptic Processing, Quality Control, Chromatography, Pharmaceutics, Regulatory Affairs, Medical Devices, Cross-functional Team..., Regulatory Requirements, Regulatory Submissions, Lifesciences, Clinical Trials, R&D, Root Cause Analysis, GCP, Cleaning Validation, Quality Auditing, Document Management, CRO, Laboratory, SOP
Education
Temple University School of Medicine 1998 — 2000
MS, quality Assurance and Regulatory Affairs
Bethany College 1986 — 1991
BA/BS, Psychology / Biology
ConcordiaValSource 2011 - Present
ValSource, LLC June 2000 - Present
Avax Technologies 2000 - 2001
SmithKline Beecham 1993 - 2000
McNeil Consumer & Specialty Pharmaceuticals 1993 - 1993
Procter and Gamble 1992 - 1993
Skills
Validation, Sop, Change Control, 21 CFR Part 11, Computer System..., GxP, GMP, GAMP, V&V, FDA, CAPA, Pharmaceutical Industry, Biopharmaceuticals, Technology Transfer, LIMS, Biotechnology, Quality System, GLP, Quality Assurance, Process Simulation, ISO 13485, Vaccines, Trackwise, Aseptic Processing, Quality Control, Chromatography, Pharmaceutics, Regulatory Affairs, Medical Devices, Cross-functional Team..., Regulatory Requirements, Regulatory Submissions, Lifesciences, Clinical Trials, R&D, Root Cause Analysis, GCP, Cleaning Validation, Quality Auditing, Document Management, CRO, Laboratory, SOP
Education
Temple University School of Medicine 1998 — 2000
MS, quality Assurance and Regulatory Affairs
Bethany College 1986 — 1991
BA/BS, Psychology / Biology
Bryan Fluke Bryan Fluke's ValSource, LLC Experience December 2000 - February 2005
Job Commissioning & Qualification Manager at RPA Engineering
Industry Pharmaceuticals
Experience
RPA Engineering February 2011 - Present
Johnson & Johnson February 2005 - January 2011
Valsource LLC December 2000 - February 2005
Kelly Scientific Resources January 2000 - December 2000
Skills
Commissioning, Validation, Engineering, GMP, Manufacturing, Compliance, Biotechnology, Risk Assessment, GAMP, Minitab, MS Project, Project Management, Business Development, CAPA, Quality Control, Change Control, FDA, FMEA, Project Engineering, Facilities Management, Quality Management, Pharmaceutical Industry, Chemical Engineering, Sop, Quality System, Quality Assurance, Cross-functional Team..., Quality Auditing, Computer System..., Chromatography, Biopharmaceuticals, Medical Devices, V&V, Vaccines, Purification, Process Simulation, Filtration, 21 CFR Part 11, Instrumentation, Process Improvement, Software Documentation, Process Engineering, R&D, Technology Transfer, Process Optimization, HVAC, Calibration, Root Cause Analysis, Process Control, Aseptic Processing
Education
Drexel University 1994 — 1999
BS, Chemical Engineering
Drexel University - College of Business and Administration 2011 — 2015
BS, Business Administration
RPA Engineering February 2011 - Present
Johnson & Johnson February 2005 - January 2011
Valsource LLC December 2000 - February 2005
Kelly Scientific Resources January 2000 - December 2000
Skills
Commissioning, Validation, Engineering, GMP, Manufacturing, Compliance, Biotechnology, Risk Assessment, GAMP, Minitab, MS Project, Project Management, Business Development, CAPA, Quality Control, Change Control, FDA, FMEA, Project Engineering, Facilities Management, Quality Management, Pharmaceutical Industry, Chemical Engineering, Sop, Quality System, Quality Assurance, Cross-functional Team..., Quality Auditing, Computer System..., Chromatography, Biopharmaceuticals, Medical Devices, V&V, Vaccines, Purification, Process Simulation, Filtration, 21 CFR Part 11, Instrumentation, Process Improvement, Software Documentation, Process Engineering, R&D, Technology Transfer, Process Optimization, HVAC, Calibration, Root Cause Analysis, Process Control, Aseptic Processing
Education
Drexel University 1994 — 1999
BS, Chemical Engineering
Drexel University - College of Business and Administration 2011 — 2015
BS, Business Administration
Carl Barnett Carl Barnett's ValSource, LLC Experience December 2009 - Present
Job Recruiting and Resource Planning at ValSource, LLC
Industry Staffing and Recruiting
Experience
ValSource, LLC December 2009 - Present
Technical Staffing Group, LLC December 2009 - December 2014
TechSource, Inc. September 2001 - November 2009
Yoh, A Day & Zimmermann Company June 1994 - September 2001
Skills
Technical Recruiting, Validation, Project Management, Quality Assurance, Recruiting, Business Development, Engineering, Medical Devices, Biotechnology, Business Operations, Talent Acquisition, Temporary Staffing, Direct Placement, Staffing Services, Human Resource Planning, Computer System..., Management, Quality Control, V&V
Education
Moravian College 1989 — 1993
Bachelor of Arts (BA)
ValSource, LLC December 2009 - Present
Technical Staffing Group, LLC December 2009 - December 2014
TechSource, Inc. September 2001 - November 2009
Yoh, A Day & Zimmermann Company June 1994 - September 2001
Skills
Technical Recruiting, Validation, Project Management, Quality Assurance, Recruiting, Business Development, Engineering, Medical Devices, Biotechnology, Business Operations, Talent Acquisition, Temporary Staffing, Direct Placement, Staffing Services, Human Resource Planning, Computer System..., Management, Quality Control, V&V
Education
Moravian College 1989 — 1993
Bachelor of Arts (BA)
Andrew David Mwase Andrew David Mwase's ValSource, LLC Experience 2006 - 2011
Job Validation Engineer and Project Manager at Genzyme, a Sanofi Company
Industry Pharmaceuticals
Experience
Genzyme July 2011 - Present
Twegaite International organization Inc May 2013 - Present
ISF 2009 - Present
Twegaite International Organization, Inc. 2009 - May 2013
Bristol-Myers Squibb February 2008 - June 2011
ValSource, LLC 2006 - 2011
Lonza 2007 - 2009
Massive Records 2006 - 2008
Altus Pharmaceuticals January 2006 - January 2007
Skills
Validation, Biotechnology, GMP, Change Control, Biopharmaceuticals, 21 CFR Part 11, CAPA, FDA, Computer System..., Technology Transfer, Pharmaceutical Industry, Regulatory Submissions, R&D, Medical Devices, Process Simulation, Sterilization, Quality Auditing, GxP, Chromatography, Quality Assurance, Regulatory Requirements, LIMS, HPLC, Filtration, Cleaning Validation, Protein Purification, Purification, Fermentation, GLP, Cell Culture, ISO 13485, Aseptic Technique, Regulatory Affairs, Quality Control, Trackwise, Organizational..., Vaccines, GCP, Strategic Planning, Leadership, Vision Setting, Risk Management, Strategic Communications, Strategic Negotiations, Business Decision Making, Conflict Resolution, Change Management, Communication
Education
Boston University 2013 — 2015
Graduate Certificate in International Business Management, International Business/Trade/Commerce
Boston University 2012 — 2015
Master of Science (MSc), Project Management
Tufts University 2004 — 2007
Ms, Biology Specializing in Biotechnology
Makerere University 1994 — 1998
Bachelor of Science (BSc), Biochemistry and Zoology
Kings College Budo
Victoria Nile
Genzyme July 2011 - Present
Twegaite International organization Inc May 2013 - Present
ISF 2009 - Present
Twegaite International Organization, Inc. 2009 - May 2013
Bristol-Myers Squibb February 2008 - June 2011
ValSource, LLC 2006 - 2011
Lonza 2007 - 2009
Massive Records 2006 - 2008
Altus Pharmaceuticals January 2006 - January 2007
Skills
Validation, Biotechnology, GMP, Change Control, Biopharmaceuticals, 21 CFR Part 11, CAPA, FDA, Computer System..., Technology Transfer, Pharmaceutical Industry, Regulatory Submissions, R&D, Medical Devices, Process Simulation, Sterilization, Quality Auditing, GxP, Chromatography, Quality Assurance, Regulatory Requirements, LIMS, HPLC, Filtration, Cleaning Validation, Protein Purification, Purification, Fermentation, GLP, Cell Culture, ISO 13485, Aseptic Technique, Regulatory Affairs, Quality Control, Trackwise, Organizational..., Vaccines, GCP, Strategic Planning, Leadership, Vision Setting, Risk Management, Strategic Communications, Strategic Negotiations, Business Decision Making, Conflict Resolution, Change Management, Communication
Education
Boston University 2013 — 2015
Graduate Certificate in International Business Management, International Business/Trade/Commerce
Boston University 2012 — 2015
Master of Science (MSc), Project Management
Tufts University 2004 — 2007
Ms, Biology Specializing in Biotechnology
Makerere University 1994 — 1998
Bachelor of Science (BSc), Biochemistry and Zoology
Kings College Budo
Victoria Nile
Dhaval Shah Dhaval Shah's ValSource, LLC Experience October 2014 - Present
Job Quality/Validation Lead at Vertex Pharmaceuticals for ValSource
Industry Pharmaceuticals
Experience
ValSource, LLC October 2014 - Present
Vertex Pharmaceuticals October 2014 - Present
Civitas Therapeutics January 2014 - October 2014
LotusWorks January 2014 - October 2014
Validation Technologies, Inc. May 2012 - January 2014
LabCorp September 2011 - May 2012
Apex Formulations Pvt Ltd August 2008 - July 2009
Lincoln Pharmaceuticals Ltd May 2008 - July 2008
Chandra Agency March 2007 - April 2008
Skills
GMP, Validation, Sop, 21 CFR Part 11, Pharmaceutics, Change Control, Quality Assurance, CAPA, V&V, Cleaning Validation, GLP, FDA, Auditing, LIMS, CIP, SIP, UV/Vis, HPLC, Pharmaceutical Industry, Process Validation, Product Validation, Analytical Techniques, Software Documentation, Wet Chemistry, Qualification Protocol..., Validation..., Root Cause Analysis, Risk Management, Project Management, Computer System..., SOP Writing, Documentation, cGMP, ISO, Lean Manufacturing, Process Manufacturing, NLCP, Pharmaceutical..., Pharmaceutical..., Process Engineering, Regulatory Affairs, Pharmaceuticals, Manufacturing, Calibration, Dissolution, Quality System, Biotechnology, GxP, GAMP, Aseptic Processing
Education
New Jersey Institute of Technology 2009 — 2011
Master of Science, Pharmaceutical Engineering
Gujarat University 2005 — 2009
Bachelors, Pharmacy
ValSource, LLC October 2014 - Present
Vertex Pharmaceuticals October 2014 - Present
Civitas Therapeutics January 2014 - October 2014
LotusWorks January 2014 - October 2014
Validation Technologies, Inc. May 2012 - January 2014
LabCorp September 2011 - May 2012
Apex Formulations Pvt Ltd August 2008 - July 2009
Lincoln Pharmaceuticals Ltd May 2008 - July 2008
Chandra Agency March 2007 - April 2008
Skills
GMP, Validation, Sop, 21 CFR Part 11, Pharmaceutics, Change Control, Quality Assurance, CAPA, V&V, Cleaning Validation, GLP, FDA, Auditing, LIMS, CIP, SIP, UV/Vis, HPLC, Pharmaceutical Industry, Process Validation, Product Validation, Analytical Techniques, Software Documentation, Wet Chemistry, Qualification Protocol..., Validation..., Root Cause Analysis, Risk Management, Project Management, Computer System..., SOP Writing, Documentation, cGMP, ISO, Lean Manufacturing, Process Manufacturing, NLCP, Pharmaceutical..., Pharmaceutical..., Process Engineering, Regulatory Affairs, Pharmaceuticals, Manufacturing, Calibration, Dissolution, Quality System, Biotechnology, GxP, GAMP, Aseptic Processing
Education
New Jersey Institute of Technology 2009 — 2011
Master of Science, Pharmaceutical Engineering
Gujarat University 2005 — 2009
Bachelors, Pharmacy
Bruce Alan Lavoie Bruce Alan Lavoie's ValSource, LLC Experience March 2015 - Present
Job Validation Engineer
Industry Medical Devices
Experience
ValSource, LLC March 2015 - Present
Acusphere, Inc. March 2011 - February 2015
COVIDIEN BIO/SPORTS SURGERY February 2008 - December 2010
Bristol-Myers Squibb Medical Imaging August 2001 - September 2007
Bristol-Myers Squibb Medical Imaging August 1998 - August 2001
Bristol-Myers Squibb Medical Imaging February 1996 - August 1998
Skills
Agile Documentation..., MS Excel, MS Word, BPCS, MS Project, Pro/Engineer, Minitab, AutoCAD
Education
Tufts University 1990 — 1992
NONE, GRADUATE STUDIES IN PHYSICS
Tufts University 1980 — 1986
BACHELOR OF SCIENCE, MECHANICAL ENGINEERING
Institut national des Sciences appliquées de Lyon 1982 — 1983
None, Engineering
ValSource, LLC March 2015 - Present
Acusphere, Inc. March 2011 - February 2015
COVIDIEN BIO/SPORTS SURGERY February 2008 - December 2010
Bristol-Myers Squibb Medical Imaging August 2001 - September 2007
Bristol-Myers Squibb Medical Imaging August 1998 - August 2001
Bristol-Myers Squibb Medical Imaging February 1996 - August 1998
Skills
Agile Documentation..., MS Excel, MS Word, BPCS, MS Project, Pro/Engineer, Minitab, AutoCAD
Education
Tufts University 1990 — 1992
NONE, GRADUATE STUDIES IN PHYSICS
Tufts University 1980 — 1986
BACHELOR OF SCIENCE, MECHANICAL ENGINEERING
Institut national des Sciences appliquées de Lyon 1982 — 1983
None, Engineering
Crystal Salinas's ValSource, LLC Experience June 2014 - Present
Job Commissioning and Technical Document Author at AstraZeneca
Industry Pharmaceuticals
Experience
AstraZeneca May 2015 - Present
ValSource, LLC June 2014 - Present
Philadelphia Freedom Valley YMCA May 2006 - Present
AstraZeneca March 2015 - May 2015
Ferring Pharmaceuticals February 2015 - March 2015
AstraZeneca June 2014 - January 2015
J.Crew November 2013 - July 2014
Philadelphia Freedom Valley YMCA May 2010 - June 2014
Pennypacker Country Club June 2010 - August 2013
DeSales University August 2010 - May 2013
Skills
Analytical Chemistry, Leadership, Microsoft Excel, Team Leadership, Chemistry, Physics, Customer Service, UV/Vis, Higher Education, Time Management, NMR, Gas Chromatography, Fundraising, Editing, Sales, Microsoft Word, PowerPoint, Microsoft Office, Judgment, Perseverance, Social Intelligence, Self-regulation, Teamwork, Social Media, IR spectroscopy, Volunteer Management, Facebook, Titration, Statistics, Public Speaking, Research, Event Planning, Social Networking, Management, Technical Writing, Scientific Writing, Training, Writing, English, Outlook, Data Analysis, Networking
Education
Villanova University 2015 — 2015
Certificate, Lean Six Sigma, Grade: A
Villanova University 2015 — 2015
Certificate, Six Sigma Green Belt, Grade: A
Villanova University 2015 — 2015
Certificate, Six Sigma Black Belt
DeSales University 2009 — 2013
Bachelor of Science, Chemistry
AstraZeneca May 2015 - Present
ValSource, LLC June 2014 - Present
Philadelphia Freedom Valley YMCA May 2006 - Present
AstraZeneca March 2015 - May 2015
Ferring Pharmaceuticals February 2015 - March 2015
AstraZeneca June 2014 - January 2015
J.Crew November 2013 - July 2014
Philadelphia Freedom Valley YMCA May 2010 - June 2014
Pennypacker Country Club June 2010 - August 2013
DeSales University August 2010 - May 2013
Skills
Analytical Chemistry, Leadership, Microsoft Excel, Team Leadership, Chemistry, Physics, Customer Service, UV/Vis, Higher Education, Time Management, NMR, Gas Chromatography, Fundraising, Editing, Sales, Microsoft Word, PowerPoint, Microsoft Office, Judgment, Perseverance, Social Intelligence, Self-regulation, Teamwork, Social Media, IR spectroscopy, Volunteer Management, Facebook, Titration, Statistics, Public Speaking, Research, Event Planning, Social Networking, Management, Technical Writing, Scientific Writing, Training, Writing, English, Outlook, Data Analysis, Networking
Education
Villanova University 2015 — 2015
Certificate, Lean Six Sigma, Grade: A
Villanova University 2015 — 2015
Certificate, Six Sigma Green Belt, Grade: A
Villanova University 2015 — 2015
Certificate, Six Sigma Black Belt
DeSales University 2009 — 2013
Bachelor of Science, Chemistry
Nancy-Ellen Sexton Nancy-Ellen Sexton's ValSource, LLC Experience March 2008 - April 2009
Job Document Control Specialist at ValSource, LLC
Industry Pharmaceuticals
Experience
MannKind Corporation January 2009 - April 2009
ValSource, LLC March 2008 - April 2009
Heritage Development Group 1997 - 2007
Fairfield County Council BSA 1986 - 1996
Fairfield County Council BSA 1986 - 1996
Newtown Montessori School 1985 - 1989
J. Walter Thompson September 1968 - February 1977
Skills
Validation, Sop, GMP, Management, Software Documentation, 21 CFR Part 11, Medical Devices, Quality Assurance, FDA, Document Management, Leadership, Pharmaceutical Industry, Quality System, Human Resources, Biotechnology
Education
Berkeley College
MannKind Corporation January 2009 - April 2009
ValSource, LLC March 2008 - April 2009
Heritage Development Group 1997 - 2007
Fairfield County Council BSA 1986 - 1996
Fairfield County Council BSA 1986 - 1996
Newtown Montessori School 1985 - 1989
J. Walter Thompson September 1968 - February 1977
Skills
Validation, Sop, GMP, Management, Software Documentation, 21 CFR Part 11, Medical Devices, Quality Assurance, FDA, Document Management, Leadership, Pharmaceutical Industry, Quality System, Human Resources, Biotechnology
Education
Berkeley College
Kirk Remick's ValSource, LLC Experience July 2001 - July 2008
Job President at Quality Source Consulting
Industry Pharmaceuticals
Arif Abbas Arif Abbas's ValSource, LLC Experience July 2003 - July 2005
Job Senior Validation Specialist at Baxter International Inc.
Industry Information Technology and Services
Experience
Baxalta October 2013 - Present
ViTAL, A Toshiba Medical Systems Group Company January 2012 - October 2013
Kroll Ontrack April 2010 - December 2011
Genmab March 2009 - January 2010
Compliance Partners February 2009 - March 2009
Mayo Clinic November 2005 - February 2009
ValSource, LLC July 2003 - July 2005
PAREXEL February 2002 - July 2003
PAREXEL February 2000 - February 2002
PAREXEL February 1998 - February 2000
Skills
Testing, Team Leadership, Test Planning, ETL, SQL, Quality Assurance, Defect Tracking, Quality Center, 21 CFR Part 11, GMP, GAMP, Test Estimation, Test Execution, Audit Support, Risk Assessment, ERP, SAP, Enterprise Architecture, Program Management, Validation, Process Validation, Software Quality..., HIPAA, SOX, Document Management, FDA, ISO standards, ICH-GCP, Change Management, Managerial Experience, Virtual Server, VMware Infrastructure, EMR, Test Strategy, Test Cases, Agile Testing, SDLC, Use Case Analysis, Requirements Analysis, Functional Design, LIMS, Electronic discovery, Agile Methodologies, Computer System..., Quality Control, Integration, V&V, Change Control, SharePoint, HP Quality Center
Education
University of Oklahoma
BS, Chemical Engineering
Baxalta October 2013 - Present
ViTAL, A Toshiba Medical Systems Group Company January 2012 - October 2013
Kroll Ontrack April 2010 - December 2011
Genmab March 2009 - January 2010
Compliance Partners February 2009 - March 2009
Mayo Clinic November 2005 - February 2009
ValSource, LLC July 2003 - July 2005
PAREXEL February 2002 - July 2003
PAREXEL February 2000 - February 2002
PAREXEL February 1998 - February 2000
Skills
Testing, Team Leadership, Test Planning, ETL, SQL, Quality Assurance, Defect Tracking, Quality Center, 21 CFR Part 11, GMP, GAMP, Test Estimation, Test Execution, Audit Support, Risk Assessment, ERP, SAP, Enterprise Architecture, Program Management, Validation, Process Validation, Software Quality..., HIPAA, SOX, Document Management, FDA, ISO standards, ICH-GCP, Change Management, Managerial Experience, Virtual Server, VMware Infrastructure, EMR, Test Strategy, Test Cases, Agile Testing, SDLC, Use Case Analysis, Requirements Analysis, Functional Design, LIMS, Electronic discovery, Agile Methodologies, Computer System..., Quality Control, Integration, V&V, Change Control, SharePoint, HP Quality Center
Education
University of Oklahoma
BS, Chemical Engineering
Donald Evanoff Donald Evanoff's ValSource, LLC Experience October 2009 - April 2012
Job
Industry Pharmaceuticals
Experience
Sharp Corporation (dba Sharp Packaging Solutions) June 2013 - Present
Sharp Corporation December 2012 - June 2013
Padtech July 2012 - November 2012
Noramco May 2012 - November 2012
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company May 2011 - April 2012
ImClone Systems May 2011 - April 2012
ValSource, LLC October 2009 - April 2012
Dendreon Corporation July 2010 - April 2011
Joseph L. Rosenberg CPA 2011 - 2011
Dendreon Corporation October 2009 - June 2010
Skills
Validation, cGMP, Facilities, SAP, SOP, Process Validation, CAPA, Change Control, GxP, FDA, Quality Assurance, Quality Systems, Technical Writing, Document Management, Pharmaceuticals, Documentation, Compliance, Problem Solving, Word, Excel, Microsoft Office, QC, GMP, CCT, Sop, Quality System, Pharmaceutical Industry, Biopharmaceuticals, Manufacturing, Computer System..., V&V
Education
Rutgers University 1991 — 1995
Bachelors
Rutgers, The State University of New Jersey-Camden 1991 — 1995
BA
Cherry Hill High School East 1988 — 1991
Diploma
Sharp Corporation (dba Sharp Packaging Solutions) June 2013 - Present
Sharp Corporation December 2012 - June 2013
Padtech July 2012 - November 2012
Noramco May 2012 - November 2012
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company May 2011 - April 2012
ImClone Systems May 2011 - April 2012
ValSource, LLC October 2009 - April 2012
Dendreon Corporation July 2010 - April 2011
Joseph L. Rosenberg CPA 2011 - 2011
Dendreon Corporation October 2009 - June 2010
Skills
Validation, cGMP, Facilities, SAP, SOP, Process Validation, CAPA, Change Control, GxP, FDA, Quality Assurance, Quality Systems, Technical Writing, Document Management, Pharmaceuticals, Documentation, Compliance, Problem Solving, Word, Excel, Microsoft Office, QC, GMP, CCT, Sop, Quality System, Pharmaceutical Industry, Biopharmaceuticals, Manufacturing, Computer System..., V&V
Education
Rutgers University 1991 — 1995
Bachelors
Rutgers, The State University of New Jersey-Camden 1991 — 1995
BA
Cherry Hill High School East 1988 — 1991
Diploma
Nicole Simpson Nicole Simpson's ValSource, LLC Experience May 2007 - August 2008
Job Verification and Validation Engineer II at HeartWare Inc
Industry Medical Devices
Experience
HeartWare Inc February 2013 - Present
Siemens Healthcare November 2011 - February 2013
University of Rochester May 2009 - May 2010
University of Rochester Medical Center January 2008 - May 2009
ValSource, LLC May 2007 - August 2008
Skills
Matlab, Labview, Algorithms, Biomedical Engineering, Testing
Education
University of Pennsylvania 2010 — 2011
MEng, Bioengineering
University of Rochester 2006 — 2010
BS, Biomedical Engineer
HeartWare Inc February 2013 - Present
Siemens Healthcare November 2011 - February 2013
University of Rochester May 2009 - May 2010
University of Rochester Medical Center January 2008 - May 2009
ValSource, LLC May 2007 - August 2008
Skills
Matlab, Labview, Algorithms, Biomedical Engineering, Testing
Education
University of Pennsylvania 2010 — 2011
MEng, Bioengineering
University of Rochester 2006 — 2010
BS, Biomedical Engineer
Marilyn Spencer Marilyn Spencer's ValSource, LLC Experience March 2011 - June 2014
Job Student at OHSU
Industry Medical Practice
Experience
ValSource, LLC March 2011 - June 2014
Genentech May 2012 - May 2014
Princeton University March 2010 - March 2011
McGill University Science Undergraduate Society May 2008 - April 2009
Bracco Diagnostics Inc. May 2008 - August 2008
Bracco Diagnostics Inc. May 2007 - August 2007
Skills
Research, FDA, Quality Assurance, Lifesciences, Molecular Biology, Validation, Microsoft Office, Biotechnology, Cleaning Validation, GMP, Sop
Education
Oregon Health and Science University 2014 — 2016
Medical Radiologic Technology/Science - Radiation Therapist
McGill University 2005 — 2009
B.Sc., Biology, biotechnology
high school 2002 — 2005
ValSource, LLC March 2011 - June 2014
Genentech May 2012 - May 2014
Princeton University March 2010 - March 2011
McGill University Science Undergraduate Society May 2008 - April 2009
Bracco Diagnostics Inc. May 2008 - August 2008
Bracco Diagnostics Inc. May 2007 - August 2007
Skills
Research, FDA, Quality Assurance, Lifesciences, Molecular Biology, Validation, Microsoft Office, Biotechnology, Cleaning Validation, GMP, Sop
Education
Oregon Health and Science University 2014 — 2016
Medical Radiologic Technology/Science - Radiation Therapist
McGill University 2005 — 2009
B.Sc., Biology, biotechnology
high school 2002 — 2005
Amy McMillion Amy McMillion's ValSource, LLC Experience January 2012 - June 2012
Job Student Physical Therapist at Kernersville Rehab Specialists
Industry Medical Practice
Experience
Kernersville Rehab Specialists June 2015 - Present
Halifax Regional Medical Center September 2014 - October 2014
Westfield Rehabilitation and Health Center July 2014 - August 2014
Stewart Physical Therapy January 2014 - February 2014
Norfolk Botanical Garden September 2012 - November 2012
ValSource, LLC January 2012 - June 2012
Skills
PowerPoint, Microsoft Word, Clinical Trials, Healthcare, Research, Quality Assurance
Education
Elon University 2012 — 2015
Doctor of Physical Therapy
Campbell University 2007 — 2011
Bachelor of Science (BS), Clinical Research
Kernersville Rehab Specialists June 2015 - Present
Halifax Regional Medical Center September 2014 - October 2014
Westfield Rehabilitation and Health Center July 2014 - August 2014
Stewart Physical Therapy January 2014 - February 2014
Norfolk Botanical Garden September 2012 - November 2012
ValSource, LLC January 2012 - June 2012
Skills
PowerPoint, Microsoft Word, Clinical Trials, Healthcare, Research, Quality Assurance
Education
Elon University 2012 — 2015
Doctor of Physical Therapy
Campbell University 2007 — 2011
Bachelor of Science (BS), Clinical Research
Serena Howes Serena Howes's ValSource, LLC Experience August 2006 - May 2007
Job Manager of Commissioning and Qualification at Genzyme
Industry Biotechnology
Experience
Genzyme November 2014 - Present
General Dynamics May 2011 - November 2014
Abbott Laboratories June 2007 - April 2011
ValSource, LLC August 2006 - May 2007
Regeneron Pharmaceuticals June 2001 - August 2006
Skills
CAPA, Process Simulation, Change Control, Quality Control, Biotechnology, Technology Transfer, Quality Assurance, Manufacturing, Sop, Pharmaceutical Industry, Validation, Quality System, Root Cause Analysis, Design of Experiments, GMP, V&V, FDA, LIMS
Education
Siena College 1996 — 2000
B.S., Biology
Genzyme November 2014 - Present
General Dynamics May 2011 - November 2014
Abbott Laboratories June 2007 - April 2011
ValSource, LLC August 2006 - May 2007
Regeneron Pharmaceuticals June 2001 - August 2006
Skills
CAPA, Process Simulation, Change Control, Quality Control, Biotechnology, Technology Transfer, Quality Assurance, Manufacturing, Sop, Pharmaceutical Industry, Validation, Quality System, Root Cause Analysis, Design of Experiments, GMP, V&V, FDA, LIMS
Education
Siena College 1996 — 2000
B.S., Biology
Thomas D. Arthur's ValSource, LLC Experience December 2013 - Present
Job Validation Engineer at ValSource, LLC
Industry Pharmaceuticals
Experience
ValSource, LLC December 2013 - Present
ValSource, LLC July 2010 - November 2013
ValSource, LLC August 2010 - August 2010
Skills
Validation, cGMP practices, Trackwise, Temperature Mapping, CTU Qualification, Portable Equipment..., Equipment Commissioning, Protocol Generation, Change Requests, Project Management, Protocol Review, Aseptic Technique, Factory Acceptance Test...
Education
Cairn University 2005 — 2010
Bachelor of Science (B.S.), Biblical Theology
Cairn University 2005 — 2010
Bachelor of Science (B.S.), Health and Physical Education
ValSource, LLC December 2013 - Present
ValSource, LLC July 2010 - November 2013
ValSource, LLC August 2010 - August 2010
Skills
Validation, cGMP practices, Trackwise, Temperature Mapping, CTU Qualification, Portable Equipment..., Equipment Commissioning, Protocol Generation, Change Requests, Project Management, Protocol Review, Aseptic Technique, Factory Acceptance Test...
Education
Cairn University 2005 — 2010
Bachelor of Science (B.S.), Biblical Theology
Cairn University 2005 — 2010
Bachelor of Science (B.S.), Health and Physical Education
Genevieve Haney's ValSource, LLC Experience November 2012 - March 2014
Job Media Marketing Specialist at HEADstrong Foundation
Industry Nonprofit Organization Management
Experience
HEADstrong Foundation March 2014 - Present
HEADstrong Foundation October 2006 - Present
ValSource, LLC November 2012 - March 2014
MKTG Services December 2011 - March 2013
Philadelphia Phillies January 2011 - 2013
Philadelphia Inquirer, Daily News, Philly.com June 2011 - September 2012
Villanova University March 2010 - June 2011
Hofstra University March 2009 - March 2010
Hofstra University October 2008 - March 2009
Masterpiece Advertising September 2008 - October 2008
Skills
Social Media Marketing, Direct Sales, Graphic Design, Sports Marketing, Retail Management, Event Management, Event Planning, Event Marketing, Corporate Events, Corporate Branding, Creative Branding, Ticket Sales, Newspaper, Logo Design, Web Design, New Media, Social Media, Event Producing, Photoshop, InDesign, Adobe Creative Suite, Promotions, Promotional Products, Public Relations Skills, Non-profit Marketing, Creative Development, Public Relations, Brand Implementation, Creative Direction, Marketing, Public Speaking, Pharmaceutical Industry, Sales, Sports, Newspapers, Brand Development, Advertising, Facebook, Sponsorship, Editing, Market Research, Social Networking, Video, Brand Management, Digital Marketing, Marketing Communications, Online Marketing, Copywriting, Direct Marketing, HTML
Education
Hofstra University 2004 — 2008
Fine Arts, Graphic Design
HEADstrong Foundation March 2014 - Present
HEADstrong Foundation October 2006 - Present
ValSource, LLC November 2012 - March 2014
MKTG Services December 2011 - March 2013
Philadelphia Phillies January 2011 - 2013
Philadelphia Inquirer, Daily News, Philly.com June 2011 - September 2012
Villanova University March 2010 - June 2011
Hofstra University March 2009 - March 2010
Hofstra University October 2008 - March 2009
Masterpiece Advertising September 2008 - October 2008
Skills
Social Media Marketing, Direct Sales, Graphic Design, Sports Marketing, Retail Management, Event Management, Event Planning, Event Marketing, Corporate Events, Corporate Branding, Creative Branding, Ticket Sales, Newspaper, Logo Design, Web Design, New Media, Social Media, Event Producing, Photoshop, InDesign, Adobe Creative Suite, Promotions, Promotional Products, Public Relations Skills, Non-profit Marketing, Creative Development, Public Relations, Brand Implementation, Creative Direction, Marketing, Public Speaking, Pharmaceutical Industry, Sales, Sports, Newspapers, Brand Development, Advertising, Facebook, Sponsorship, Editing, Market Research, Social Networking, Video, Brand Management, Digital Marketing, Marketing Communications, Online Marketing, Copywriting, Direct Marketing, HTML
Education
Hofstra University 2004 — 2008
Fine Arts, Graphic Design
Greg Kroll Greg Kroll's ValSource, LLC Experience June 2010 - September 2011
Job Serialization Engineer at PCI (Packaging Coordinators Inc)
Industry Pharmaceuticals
Experience
PCI (Packaging Coordinators Inc) July 2015 - Present
MedImmune May 2013 - July 2015
MedImmune April 2012 - May 2013
ValSource, LLC June 2010 - September 2011
Hyde Engineering + Consulting March 2009 - June 2010
Omni National Bank June 2006 - March 2009
Colorcon February 2005 - May 2006
CE&IC July 1999 - January 2005
Skills
Validation, GMP, Process Engineering, Project Management, Instrumentation, Software Documentation, Biotechnology, Sop, Reviews, V&V, Commissioning, FDA, Manufacturing, Change Control, Engineering, Quality Control, CAPA, Lifesciences, Medical Devices, Life Sciences, Serialization
Education
University of Pennsylvania 1995 — 1999
BSE, Chemical Engineering
PCI (Packaging Coordinators Inc) July 2015 - Present
MedImmune May 2013 - July 2015
MedImmune April 2012 - May 2013
ValSource, LLC June 2010 - September 2011
Hyde Engineering + Consulting March 2009 - June 2010
Omni National Bank June 2006 - March 2009
Colorcon February 2005 - May 2006
CE&IC July 1999 - January 2005
Skills
Validation, GMP, Process Engineering, Project Management, Instrumentation, Software Documentation, Biotechnology, Sop, Reviews, V&V, Commissioning, FDA, Manufacturing, Change Control, Engineering, Quality Control, CAPA, Lifesciences, Medical Devices, Life Sciences, Serialization
Education
University of Pennsylvania 1995 — 1999
BSE, Chemical Engineering
Keiwanna Harris's ValSource, LLC Experience January 2010 - February 2014
Job Senior Validation Engineer
Industry Pharmaceuticals
Experience
bioMerieux February 2014 - Present
ValSource, LLC January 2010 - February 2014
Hospira 2001 - 2006
Delphi January 1998 - 2001
Skills
21 CFR Part 11, Computer System..., Change Control, GAMP, Aseptic Processing, FMEA, Trackwise, Protocol, Documentum, Lean Manufacturing, Six Sigma, FDA, V&V, Cleaning Validation, Process Engineering, GMP, CAPA, Validation, Quality Assurance, GxP, Quality System, Root Cause Analysis, Biotechnology, Sop, Software Documentation, GLP, Technology Transfer, SOP, Pharmaceutical Industry
Education
Grambling State University
bioMerieux February 2014 - Present
ValSource, LLC January 2010 - February 2014
Hospira 2001 - 2006
Delphi January 1998 - 2001
Skills
21 CFR Part 11, Computer System..., Change Control, GAMP, Aseptic Processing, FMEA, Trackwise, Protocol, Documentum, Lean Manufacturing, Six Sigma, FDA, V&V, Cleaning Validation, Process Engineering, GMP, CAPA, Validation, Quality Assurance, GxP, Quality System, Root Cause Analysis, Biotechnology, Sop, Software Documentation, GLP, Technology Transfer, SOP, Pharmaceutical Industry
Education
Grambling State University
Colin O'Donnell Colin O'Donnell's ValSource, LLC Experience June 2014 - August 2015
Job Commissioning & Validation Engineer at DPS Engineering
Industry Mechanical or Industrial Engineering
Experience
DPS Engineering August 2015 - Present
ValSource, LLC June 2014 - August 2015
Pratt & Whitney May 2013 - August 2013
Flanagan Industries June 2012 - August 2012
Skills
AutoCAD, Microsoft Word, Microsoft Excel, Microsoft Office, Pro Engineer, NX Unigraphics, Marketing, Data Analysis, Engineering
Education
Syracuse University 2010 — 2014
Bachelor of Science (BS), Major in Mechanical Engineering/Minor in Mathematics and Business Management
DPS Engineering August 2015 - Present
ValSource, LLC June 2014 - August 2015
Pratt & Whitney May 2013 - August 2013
Flanagan Industries June 2012 - August 2012
Skills
AutoCAD, Microsoft Word, Microsoft Excel, Microsoft Office, Pro Engineer, NX Unigraphics, Marketing, Data Analysis, Engineering
Education
Syracuse University 2010 — 2014
Bachelor of Science (BS), Major in Mechanical Engineering/Minor in Mathematics and Business Management
Jared Moskowitz Jared Moskowitz's ValSource, LLC Experience November 2012 - August 2015
Job Validation Specialist at Genzyme, a Sanofi company
Industry Pharmaceuticals
Experience
Genzyme, a Sanofi company August 2015 - Present
ValSource, LLC November 2012 - August 2015
New Jersey Parks and Services June 2009 - August 2010
Monmouth County Prosecutor's Office June 2008 - August 2008
Skills
Nutrition, Validation, Process Validation, Commissioning, Organizational..., Committed to..., V&V, Pharmaceutical Industry, Leadership, Research, FDA, Change Control
Education
Syracuse University 2008 — 2012
Bachelor's Degree
Genzyme, a Sanofi company August 2015 - Present
ValSource, LLC November 2012 - August 2015
New Jersey Parks and Services June 2009 - August 2010
Monmouth County Prosecutor's Office June 2008 - August 2008
Skills
Nutrition, Validation, Process Validation, Commissioning, Organizational..., Committed to..., V&V, Pharmaceutical Industry, Leadership, Research, FDA, Change Control
Education
Syracuse University 2008 — 2012
Bachelor's Degree
Ricardo Colón Ricardo Colón's ValSource, LLC Experience November 2012 - Present
Job Sr. Validation Engineer at ValSource
Industry Biotechnology
Experience
ValSource, LLC November 2012 - Present
Baxalta September 2013 - Present
Baxter Healthcare November 2012 - September 2013
Global Turn Key Services October 2009 - September 2012
Bristol-Myers Squibb October 2009 - September 2012
STERIS Corporation May 2008 - May 2009
Fluor Daniel May 2003 - December 2007
Construction Engineering 2001 - May 2003
Skills
HVAC, CIP, SCADA, Purification, Packaging, Autoclave, Validation, Commissioning, Chromatography, Change Control, cGMP, Cleaning Validation, GMP, SOP, FDA, 21 CFR Part 11, Pharmaceuticals, Biotechnology, Calibration, LIMS, Life Sciences, Validations, Biopharmaceuticals, Compliance, Technical Writing, Manufacturing, GxP, Sop, Pharmaceutical Industry, CAPA, Aseptic Processing, Engineering, V&V, GAMP, Testing, Lifesciences, Quality System, Software Documentation, GLP
Education
Universidad del Turabo 2005 — 2007
MBA, Project Management
Universidad del Turabo 1997 — 2002
BS, Mechanical Engineer
bonneville 1997 — 1997
ValSource, LLC November 2012 - Present
Baxalta September 2013 - Present
Baxter Healthcare November 2012 - September 2013
Global Turn Key Services October 2009 - September 2012
Bristol-Myers Squibb October 2009 - September 2012
STERIS Corporation May 2008 - May 2009
Fluor Daniel May 2003 - December 2007
Construction Engineering 2001 - May 2003
Skills
HVAC, CIP, SCADA, Purification, Packaging, Autoclave, Validation, Commissioning, Chromatography, Change Control, cGMP, Cleaning Validation, GMP, SOP, FDA, 21 CFR Part 11, Pharmaceuticals, Biotechnology, Calibration, LIMS, Life Sciences, Validations, Biopharmaceuticals, Compliance, Technical Writing, Manufacturing, GxP, Sop, Pharmaceutical Industry, CAPA, Aseptic Processing, Engineering, V&V, GAMP, Testing, Lifesciences, Quality System, Software Documentation, GLP
Education
Universidad del Turabo 2005 — 2007
MBA, Project Management
Universidad del Turabo 1997 — 2002
BS, Mechanical Engineer
bonneville 1997 — 1997
Andrew Haney Andrew Haney's ValSource, LLC Experience October 2002 - April 2009
Job PIMS Product Support Manager at Engineering Software Solutions LLC
Industry Information Technology and Services
Experience
Engineering Software Solutions LLC October 2002 - Present
ValSource, LLC October 2002 - April 2009
Skills
Change Control, 21 CFR Part 11, Validation, Commissioning, Pharmaceutical Industry, Computer System..., GxP, FDA, GMP, CAPA, V&V, Sop, Quality Assurance, Technology Transfer, Quality System, Aseptic Processing, Software Documentation, LIMS, Pharmaceutics, GAMP, PIMS
Education
Rider University 1998 — 2002
BSBA, Business
Engineering Software Solutions LLC October 2002 - Present
ValSource, LLC October 2002 - April 2009
Skills
Change Control, 21 CFR Part 11, Validation, Commissioning, Pharmaceutical Industry, Computer System..., GxP, FDA, GMP, CAPA, V&V, Sop, Quality Assurance, Technology Transfer, Quality System, Aseptic Processing, Software Documentation, LIMS, Pharmaceutics, GAMP, PIMS
Education
Rider University 1998 — 2002
BSBA, Business
Monzer Elabbasi's ValSource, LLC Experience March 2008 - April 2014
Job Senior Consultant at Deloitte
Industry Pharmaceuticals
Experience
Deloitte May 2014 - Present
Merck May 2011 - April 2014
ValSource, LLC March 2008 - April 2014
Dendreon May 2009 - May 2011
Schering Plough March 2008 - September 2009
Compliance Technology Group, Inc July 2005 - March 2008
Sanofi Pastreur, Inc. 2007 - 2008
sanofi-aventis (Contractor via CTG) 2006 - 2007
Roche Molecular Systems/ Roche Diagnostics 2005 - 2006
CSSC Inc July 2003 - July 2005
Skills
Validation, Change Control, Computer System..., V&V, 21 CFR Part 11, FDA, Manufacturing, Sop, Quality Assurance, Project Management, Commissioning, Biopharmaceuticals, GxP, GMP, GAMP, GLP, Facilities Management, Pharmaceutical Industry, CAPA, Aseptic Processing, LIMS, Research, Technical Writing, Vaccines, Cross-functional Team..., Quality System, ISO 13485, Testing, Biotechnology, LEED, Water Treatment, Cleaning Validation, Medical Devices, HVAC, Root Cause Analysis, Regulatory Affairs, Construction Safety, Utilities Management, Technical Reviews, Job Scheduling, Project Control, Safety, Technical Staff..., Procedure Development, SOP development, Commissioning Management, Maintenance & Repair, Production Facilities, ASTM standards, Supply Chain Management
Education
New Jersey Institute of Technology
BS, Mechanical Engineering
Deloitte May 2014 - Present
Merck May 2011 - April 2014
ValSource, LLC March 2008 - April 2014
Dendreon May 2009 - May 2011
Schering Plough March 2008 - September 2009
Compliance Technology Group, Inc July 2005 - March 2008
Sanofi Pastreur, Inc. 2007 - 2008
sanofi-aventis (Contractor via CTG) 2006 - 2007
Roche Molecular Systems/ Roche Diagnostics 2005 - 2006
CSSC Inc July 2003 - July 2005
Skills
Validation, Change Control, Computer System..., V&V, 21 CFR Part 11, FDA, Manufacturing, Sop, Quality Assurance, Project Management, Commissioning, Biopharmaceuticals, GxP, GMP, GAMP, GLP, Facilities Management, Pharmaceutical Industry, CAPA, Aseptic Processing, LIMS, Research, Technical Writing, Vaccines, Cross-functional Team..., Quality System, ISO 13485, Testing, Biotechnology, LEED, Water Treatment, Cleaning Validation, Medical Devices, HVAC, Root Cause Analysis, Regulatory Affairs, Construction Safety, Utilities Management, Technical Reviews, Job Scheduling, Project Control, Safety, Technical Staff..., Procedure Development, SOP development, Commissioning Management, Maintenance & Repair, Production Facilities, ASTM standards, Supply Chain Management
Education
New Jersey Institute of Technology
BS, Mechanical Engineering
John Molaskey's ValSource, LLC Experience
Job Regional Manager, Northeast at ValSource, LLC
Industry Biotechnology
Experience
ValSource, LLC
Skills
Computer System..., Validation, Change Control, Pharmaceutical Industry, V&V, Sop, CAPA, FDA, Quality Assurance, LIMS, GMP, Medical Devices, Biopharmaceuticals, Technology Transfer, SOP
Education
University of Massachusetts Lowell
ValSource, LLC
Skills
Computer System..., Validation, Change Control, Pharmaceutical Industry, V&V, Sop, CAPA, FDA, Quality Assurance, LIMS, GMP, Medical Devices, Biopharmaceuticals, Technology Transfer, SOP
Education
University of Massachusetts Lowell
Umesh Rao's ValSource, LLC Experience March 2003 - September 2005
Job Sr. Automation & Controls Engineer at Genzyme
Industry Biotechnology
Experience
Genzyme July 2012 - Present
AstraZeneca Pharmaceuticals March 2003 - July 2012
AstraZeneca March 2003 - July 2012
ValSource, LLC March 2003 - September 2005
AstraZeneca Pharmaceuticals 2003 - January 2005
E-Softsys LLC May 2001 - March 2003
Infortech Software September 1998 - May 2001
Skills
C++, Oracle, Microsoft SQL Server, .NET, C, TWS, Visual C++, Ladder Logic, Validation, 21 CFR Part 11, GMP, Change Control, Computer System..., FDA, Pharmaceutical Industry, Quality Assurance, GAMP, Technology Transfer, GxP, CAPA, Automation, V&V, Project Management, Biotechnology, Sop, Process Control, Process Simulation, Quality System, R&D, SCADA, PLC, Medical Devices, LIMS, SDLC, Quality Control, ISO, Process Engineering, Calibration, MES, Testing, Visual Basic, Root Cause Analysis, Visio, Software Development, Six Sigma, Process Optimization, Pharmaceutics, Process Automation, Manufacturing, Commissioning
Education
Manipal Institute of Technology 1994 — 1998
B.E, Computer Science
Genzyme July 2012 - Present
AstraZeneca Pharmaceuticals March 2003 - July 2012
AstraZeneca March 2003 - July 2012
ValSource, LLC March 2003 - September 2005
AstraZeneca Pharmaceuticals 2003 - January 2005
E-Softsys LLC May 2001 - March 2003
Infortech Software September 1998 - May 2001
Skills
C++, Oracle, Microsoft SQL Server, .NET, C, TWS, Visual C++, Ladder Logic, Validation, 21 CFR Part 11, GMP, Change Control, Computer System..., FDA, Pharmaceutical Industry, Quality Assurance, GAMP, Technology Transfer, GxP, CAPA, Automation, V&V, Project Management, Biotechnology, Sop, Process Control, Process Simulation, Quality System, R&D, SCADA, PLC, Medical Devices, LIMS, SDLC, Quality Control, ISO, Process Engineering, Calibration, MES, Testing, Visual Basic, Root Cause Analysis, Visio, Software Development, Six Sigma, Process Optimization, Pharmaceutics, Process Automation, Manufacturing, Commissioning
Education
Manipal Institute of Technology 1994 — 1998
B.E, Computer Science
T.J. Rivet's ValSource, LLC Experience 1996 - 2001
Job Owner, Prescott Associates
Industry Pharmaceuticals
Experience
Prescott Associates January 1997 - Present
Wyeth Biotech 1997 - 2008
ValSource, LLC 1996 - 2001
Raytheon Engineers and Constructors 1995 - 1997
Repligen Corporation 1992 - 1994
Skills
Pharmaceutical Industry, Validation, GMP, Sop
Education
Assumption College 1988 — 1992
BS
Westford Academy 1984 — 1988
Prescott Associates January 1997 - Present
Wyeth Biotech 1997 - 2008
ValSource, LLC 1996 - 2001
Raytheon Engineers and Constructors 1995 - 1997
Repligen Corporation 1992 - 1994
Skills
Pharmaceutical Industry, Validation, GMP, Sop
Education
Assumption College 1988 — 1992
BS
Westford Academy 1984 — 1988
Ray Lockard's ValSource, LLC Experience September 1996 - April 2001
Job Senior Director, Supply Chain Strategy at Alnylam Pharmaceuticals
Industry Biotechnology
Experience
Alnylam Pharmaceuticals April 2014 - 2015
Alnylam Pharmaceuticals August 2011 - April 2014
Alnylam 2005 - August 2011
Alnylam Pharmaceuticals 2007 - 2009
Biogen 2001 - 2005
ValSource, LLC September 1996 - April 2001
Education
University of North Carolina at Chapel Hill - Kenan-Flagler Business School 2003 — 2005
Masters, Business Administration
Hampden-Sydney College 1991 — 1995
BS, Biology
Alnylam Pharmaceuticals April 2014 - 2015
Alnylam Pharmaceuticals August 2011 - April 2014
Alnylam 2005 - August 2011
Alnylam Pharmaceuticals 2007 - 2009
Biogen 2001 - 2005
ValSource, LLC September 1996 - April 2001
Education
University of North Carolina at Chapel Hill - Kenan-Flagler Business School 2003 — 2005
Masters, Business Administration
Hampden-Sydney College 1991 — 1995
BS, Biology
Maria DeLuca's ValSource, LLC Experience June 2014 - April 2015
Job ValSource
Industry Pharmaceuticals
Experience
PRA Health Sciences June 2015 - Present
ValSource, LLC June 2014 - April 2015
Merck January 2011 - April 2011
Merck October 2009 - January 2011
Bristol-Myers Squibb March 2009 - September 2009
Schering-Plough Research Institute February 1998 - January 2009
Schering 1998 - 2006
Skills
21 CFR Part 11, Validation, GMP, GxP, Change Control, Software Documentation, FDA, Pharmaceutical Industry, Sop, Technology Transfer
Education
Rutgers, The State University of New Jersey-New Brunswick 1994 — 1998
Bachelor's degree, Chemistry
PRA Health Sciences June 2015 - Present
ValSource, LLC June 2014 - April 2015
Merck January 2011 - April 2011
Merck October 2009 - January 2011
Bristol-Myers Squibb March 2009 - September 2009
Schering-Plough Research Institute February 1998 - January 2009
Schering 1998 - 2006
Skills
21 CFR Part 11, Validation, GMP, GxP, Change Control, Software Documentation, FDA, Pharmaceutical Industry, Sop, Technology Transfer
Education
Rutgers, The State University of New Jersey-New Brunswick 1994 — 1998
Bachelor's degree, Chemistry
Dennis Muoio's ValSource, LLC Experience October 2014 - Present
Job Validation Specialist at Valsource
Industry Biotechnology
Experience
Valsource LLC October 2014 - Present
Manufacturing Associate Genzyme May 2011 - April 2014
Amgen Rhode Island January 2006 - October 2010
Biovest International February 2005 - December 2005
Transkaryotic Therapies, Inc November 2001 - December 2003
Altus Biologics September 1999 - November 2001
Skills
Biotechnology, Aseptic Technique, GMP, Biopharmaceuticals, Sop, LIMS, Purification, Pharmaceutical Industry, Validation, FDA, Chromatography, Cleaning Validation, Protein Purification, CAPA, Filtration, Protein Chemistry, SOP
Education
Western New England College 1992 — 1996
Bachelor of Science, General Biology; Biology
Boston University
Western New England College 1992 — 1996
Bachelor of Science (BS), Biology/Biological Sciences, General
Valsource LLC October 2014 - Present
Manufacturing Associate Genzyme May 2011 - April 2014
Amgen Rhode Island January 2006 - October 2010
Biovest International February 2005 - December 2005
Transkaryotic Therapies, Inc November 2001 - December 2003
Altus Biologics September 1999 - November 2001
Skills
Biotechnology, Aseptic Technique, GMP, Biopharmaceuticals, Sop, LIMS, Purification, Pharmaceutical Industry, Validation, FDA, Chromatography, Cleaning Validation, Protein Purification, CAPA, Filtration, Protein Chemistry, SOP
Education
Western New England College 1992 — 1996
Bachelor of Science, General Biology; Biology
Boston University
Western New England College 1992 — 1996
Bachelor of Science (BS), Biology/Biological Sciences, General
Adam Yacoub's ValSource, LLC Experience March 2008 - Present
Job Validation Consultant at AstraZeneca
Industry Biotechnology
Experience
ValSource, LLC March 2008 - Present
Skills
Validation, Pharmaceuticals, 21 CFR Part 11, Change Control, GxP, GMP, Sop, Cleaning Validation, Aseptic Processing, Quality Assurance, Document Management, Process Simulation, Cell Culture, Purification, Computer System..., Protocol
Education
University of New Hampshire 1996 — 2001
Bachelor of Science, Pre-Veterinary Medicine
ValSource, LLC March 2008 - Present
Skills
Validation, Pharmaceuticals, 21 CFR Part 11, Change Control, GxP, GMP, Sop, Cleaning Validation, Aseptic Processing, Quality Assurance, Document Management, Process Simulation, Cell Culture, Purification, Computer System..., Protocol
Education
University of New Hampshire 1996 — 2001
Bachelor of Science, Pre-Veterinary Medicine
Karl Swanson's ValSource, LLC Experience July 2007 - October 2009
Job Manufacturing Lead Technician Cell Culture at Biogenidec
Industry Biotechnology
Experience
Biogenidec November 2009 - Present
ValSource, LLC July 2007 - October 2009
Biogen Idec July 2007 - October 2009
Amgen May 2007 - July 2007
Skills
Validation, Cell Culture, Manufacturing, Aseptic Processing
Education
University of Massachusetts, Amherst 1983 — 1987
Biogenidec November 2009 - Present
ValSource, LLC July 2007 - October 2009
Biogen Idec July 2007 - October 2009
Amgen May 2007 - July 2007
Skills
Validation, Cell Culture, Manufacturing, Aseptic Processing
Education
University of Massachusetts, Amherst 1983 — 1987
Jeff Gerstein's ValSource, LLC Experience January 2000 - December 2005
Job Director of CQV at DPS Engineering
Industry Biotechnology
Experience
DPS Engineering April 2015 - Present
Integrated Commissioning & Qualification, Corp. August 2011 - March 2015
US Army December 2005 - August 2011
General Technical Services December 2005 - August 2011
ValSource, LLC January 2000 - December 2005
AHA Consulting Engineers March 1998 - December 1999
Skills
FDA, Quality System, Quality Assurance, Systems Engineering, CAPA, Process Engineering, Commissioning, Testing, Quality Management, Quality Control, V&V, Sop, Medical Devices, Manufacturing, SOP, Biotechnology, GMP
Education
Northeastern University
Mechanical Engineering
Worcester Polytechnic Institute
Woburn High
DPS Engineering April 2015 - Present
Integrated Commissioning & Qualification, Corp. August 2011 - March 2015
US Army December 2005 - August 2011
General Technical Services December 2005 - August 2011
ValSource, LLC January 2000 - December 2005
AHA Consulting Engineers March 1998 - December 1999
Skills
FDA, Quality System, Quality Assurance, Systems Engineering, CAPA, Process Engineering, Commissioning, Testing, Quality Management, Quality Control, V&V, Sop, Medical Devices, Manufacturing, SOP, Biotechnology, GMP
Education
Northeastern University
Mechanical Engineering
Worcester Polytechnic Institute
Woburn High
John H Perley's ValSource, LLC Experience February 2015 - Present
Job Automation Project Manager at ValSource, LLC
Industry Pharmaceuticals
Experience
ValSource, LLC February 2015 - Present
Merck March 2003 - January 2015
Lucent 1995 - 2001
Skills
Management, Pharmaceutical Industry, 21 CFR Part 11, Change Control, Computer System..., Validation, GMP, Sop, GxP, FDA, LIMS, CAPA, Biotechnology, GLP, Cross-functional Team..., GCP, Technology Transfer, Lifesciences, Quality Assurance
Education
Rutgers, The State University of New Jersey-Newark 1976 — 1982
Business/Managerial Economics
ValSource, LLC February 2015 - Present
Merck March 2003 - January 2015
Lucent 1995 - 2001
Skills
Management, Pharmaceutical Industry, 21 CFR Part 11, Change Control, Computer System..., Validation, GMP, Sop, GxP, FDA, LIMS, CAPA, Biotechnology, GLP, Cross-functional Team..., GCP, Technology Transfer, Lifesciences, Quality Assurance
Education
Rutgers, The State University of New Jersey-Newark 1976 — 1982
Business/Managerial Economics
Aleta O'Brien's ValSource, LLC Experience August 1999 - May 2011
Job Principal Quality Engineer at Genzyme
Industry Pharmaceuticals
Experience
Genzyme May 2011 - Present
ValSource, LLC August 1999 - May 2011
Genetics Institute/Wyeth August 1998 - August 1999
KMI/Parexel March 1996 - March 1998
Skills
Quality Assurance, Validation, Change Control, Sop, V&V, Quality Control, Cross-functional Team...
Education
Western New England University 2000 — 2002
Masters, Business Adminstration
Bentley University 1999 — 1999
Certificate, Project Management
University of Massachusetts, Amherst 1989 — 1995
BS, Chemical Engineering, Minor Chemistry
Genzyme May 2011 - Present
ValSource, LLC August 1999 - May 2011
Genetics Institute/Wyeth August 1998 - August 1999
KMI/Parexel March 1996 - March 1998
Skills
Quality Assurance, Validation, Change Control, Sop, V&V, Quality Control, Cross-functional Team...
Education
Western New England University 2000 — 2002
Masters, Business Adminstration
Bentley University 1999 — 1999
Certificate, Project Management
University of Massachusetts, Amherst 1989 — 1995
BS, Chemical Engineering, Minor Chemistry
Amy Markey's ValSource, LLC Experience 2002 - 2005
Job Quality Assurance at Spark Therapeutics, Inc.
Industry Biotechnology
Experience
Spark Therapeutics, Inc. 2014 - Present
Nuron Biotech Inc 2011 - 2014
MedImmune 2010 - 2011
Tengion 2005 - 2010
ValSource, LLC 2002 - 2005
Aventis Behring 2000 - 2002
GlaxoSmithKline 1998 - 2000
Wyeth 1996 - 1998
Raytheon Engineers & Constructors 1992 - 1996
Centocor 1990 - 1992
Skills
Validation, Quality Assurance, Microbiology, GMP, CAPA, FDA, Sop, Biotechnology, Change Control, 21 CFR Part 11, Biopharmaceuticals, Technology Transfer, Computer System..., Regulatory Submissions, Clinical Development, Quality System, GxP, Aseptic Processing, Quality Auditing, EDC, Regulatory Affairs, IND, V&V, Vaccines, LIMS, GCP, Cleaning Validation, SOP
Education
Immaculata University 1987 — 1991
BA, Biology
Spark Therapeutics, Inc. 2014 - Present
Nuron Biotech Inc 2011 - 2014
MedImmune 2010 - 2011
Tengion 2005 - 2010
ValSource, LLC 2002 - 2005
Aventis Behring 2000 - 2002
GlaxoSmithKline 1998 - 2000
Wyeth 1996 - 1998
Raytheon Engineers & Constructors 1992 - 1996
Centocor 1990 - 1992
Skills
Validation, Quality Assurance, Microbiology, GMP, CAPA, FDA, Sop, Biotechnology, Change Control, 21 CFR Part 11, Biopharmaceuticals, Technology Transfer, Computer System..., Regulatory Submissions, Clinical Development, Quality System, GxP, Aseptic Processing, Quality Auditing, EDC, Regulatory Affairs, IND, V&V, Vaccines, LIMS, GCP, Cleaning Validation, SOP
Education
Immaculata University 1987 — 1991
BA, Biology
Leslie Nowicki's ValSource, LLC Experience March 2008 - January 2010
Job Consulting/contractor Validation services provider
Industry Medical Devices
Experience
Bio-Med Validation Services LLC August 2012 - Present
Grand River Aseptic Manufacturing January 2011 - January 2011
Regeneron Pharmaceuticals October 2010 - December 2010
Hospira August 2010 - September 2010
B.Braun Medical May 2010 - July 2010
Black Diamond Network March 2010 - April 2010
ValSource LLC March 2008 - January 2010
GSK Bio Marietta with AVS November 2006 - November 2007
Boston Scientific March 2005 - October 2005
Eli Lilly and Company 2004 - 2005
Skills
Change Control, Software Documentation, 21 CFR Part 11, Medical Devices, Validation, Six Sigma, LIMS, Autoclave, Biotechnology, CAPA, Quality Assurance, HPLC, Pharmaceutical Industry, Computer System..., V&V, Quality System, Sop, Manufacturing, GMP, Design of Experiments, Commissioning, FDA, Quality Control, GxP, ISO 13485, Cleaning Validation, Biopharmaceuticals, GLP, Technology Transfer, GAMP, Regulatory Affairs, Automation, Process Simulation, Aseptic Processing
Education
State University of New York College at Brockport 1994 — 2000
Master of Science, Science Education
Tri-State University 1979 — 1984
Bachelor of Science, Chemical Engineering
Bio-Med Validation Services LLC August 2012 - Present
Grand River Aseptic Manufacturing January 2011 - January 2011
Regeneron Pharmaceuticals October 2010 - December 2010
Hospira August 2010 - September 2010
B.Braun Medical May 2010 - July 2010
Black Diamond Network March 2010 - April 2010
ValSource LLC March 2008 - January 2010
GSK Bio Marietta with AVS November 2006 - November 2007
Boston Scientific March 2005 - October 2005
Eli Lilly and Company 2004 - 2005
Skills
Change Control, Software Documentation, 21 CFR Part 11, Medical Devices, Validation, Six Sigma, LIMS, Autoclave, Biotechnology, CAPA, Quality Assurance, HPLC, Pharmaceutical Industry, Computer System..., V&V, Quality System, Sop, Manufacturing, GMP, Design of Experiments, Commissioning, FDA, Quality Control, GxP, ISO 13485, Cleaning Validation, Biopharmaceuticals, GLP, Technology Transfer, GAMP, Regulatory Affairs, Automation, Process Simulation, Aseptic Processing
Education
State University of New York College at Brockport 1994 — 2000
Master of Science, Science Education
Tri-State University 1979 — 1984
Bachelor of Science, Chemical Engineering
James Howley's ValSource, LLC Experience 2001 - 2003
Job Senior Manager Quality Assurance at Amgen
Industry Biotechnology
Experience
Amgen qualityamgn2004 - 2008
ValSource, LLC 2001 - 2003
Education
Colby College 1992 — 1996
Amgen qualityamgn2004 - 2008
ValSource, LLC 2001 - 2003
Education
Colby College 1992 — 1996
Kacey Holmewood's ValSource, LLC Experience June 2007 - April 2009
Job QA Lead Engineer at GE Healthcare
Industry Medical Devices
Experience
GE Healthcare April 2013 - Present
GE Healthcare April 2009 - March 2013
Valsource, LLC June 2007 - April 2009
Lonza Biologics January 2006 - June 2007
Regeneron Pharmaceuticals 2000 - 2006
Skills
Validation, Quality Assurance, 21 CFR Part 11, Change Control, Cleaning Validation, GMP, CAPA, Computer System..., Sop, GxP, FDA, ISO 13485
Education
State University of New York at Albany 2001 — 2004
Master of Business Administration (MBA), Business Administration and Management, General
State Univeristy of New York @ Albany 1997 — 1999
Bachelor of Arts (B.A.), Biology & Psychology
GE Healthcare April 2013 - Present
GE Healthcare April 2009 - March 2013
Valsource, LLC June 2007 - April 2009
Lonza Biologics January 2006 - June 2007
Regeneron Pharmaceuticals 2000 - 2006
Skills
Validation, Quality Assurance, 21 CFR Part 11, Change Control, Cleaning Validation, GMP, CAPA, Computer System..., Sop, GxP, FDA, ISO 13485
Education
State University of New York at Albany 2001 — 2004
Master of Business Administration (MBA), Business Administration and Management, General
State Univeristy of New York @ Albany 1997 — 1999
Bachelor of Arts (B.A.), Biology & Psychology
Stanley Garib's ValSource, LLC Experience December 2008 - Present
Job Validation Consultant at ValSource, LLC
Industry Biotechnology
Experience
ValSource, LLC December 2008 - Present
Validation Specialists May 2005 - June 2008
Wyeth Biotech May 2005 - June 2008
Validation Specialists/Wyeth Biotech 2005 - 2008
Infimed Therapeutics 2000 - 2002
Intelligent Biocides 1998 - 2000
Education
Boston University 1993 — 1998
ValSource, LLC December 2008 - Present
Validation Specialists May 2005 - June 2008
Wyeth Biotech May 2005 - June 2008
Validation Specialists/Wyeth Biotech 2005 - 2008
Infimed Therapeutics 2000 - 2002
Intelligent Biocides 1998 - 2000
Education
Boston University 1993 — 1998
Paul Provencal Jr's ValSource, LLC Experience October 2007 - August 2008
Job
Industry Biotechnology
Experience
Thermo Fisher Scientific July 2014 - Present
Thermo Fisher Scientific October 2010 - July 2014
Shire HGT August 2008 - October 2010
ValSource, LLC October 2007 - August 2008
Amgen October 2005 - October 2007
Education
Providence College 1999 — 2003
Bachelor of Science
Bishop Hendricken High School 1996 — 1999
Thermo Fisher Scientific July 2014 - Present
Thermo Fisher Scientific October 2010 - July 2014
Shire HGT August 2008 - October 2010
ValSource, LLC October 2007 - August 2008
Amgen October 2005 - October 2007
Education
Providence College 1999 — 2003
Bachelor of Science
Bishop Hendricken High School 1996 — 1999
Christopher Karcz's ValSource, LLC Experience November 2009 - January 2011
Job Validation Engineer at Genzyme
Industry Medical Devices
Experience
Montville High School August 2009 - October 2011
ValSource, LLC November 2009 - January 2011
Rutgers University September 2008 - May 2009
Red Bull New York March 2007 - March 2008
J&J Contractors June 1999 - August 2006
Skills
Matlab, Biomedical Engineering, Labview, Medical Devices, Microsoft Office, Word, Validation, PowerPoint, Research, CAD, C++, Product Development, Technical Writing, cGMP, GMP, Engineering, Programming, Cell Culture, R&D, Biotechnology, Excel, Solidworks, Problem Solving, Cleaning Validation, Sterilization Validation, Equipment Validation, Biomechanics, Autoclave, Trackwise, 21 CFR Part 11
Education
Rutgers University-New Brunswick 2001 — 2009
BS, Biomedical Engineering
Montville High School August 2009 - October 2011
ValSource, LLC November 2009 - January 2011
Rutgers University September 2008 - May 2009
Red Bull New York March 2007 - March 2008
J&J Contractors June 1999 - August 2006
Skills
Matlab, Biomedical Engineering, Labview, Medical Devices, Microsoft Office, Word, Validation, PowerPoint, Research, CAD, C++, Product Development, Technical Writing, cGMP, GMP, Engineering, Programming, Cell Culture, R&D, Biotechnology, Excel, Solidworks, Problem Solving, Cleaning Validation, Sterilization Validation, Equipment Validation, Biomechanics, Autoclave, Trackwise, 21 CFR Part 11
Education
Rutgers University-New Brunswick 2001 — 2009
BS, Biomedical Engineering
Doug Endy's ValSource, LLC Experience August 2012 - December 2014
Job Senior Process Engineer at Hyde Engineering + Consulting
Industry Biotechnology
Experience
Hyde Engineering + Consulting January 2015 - Present
ValSource, LLC August 2012 - December 2014
LifeTek Solutions June 2005 - August 2012
O'Brien & Gere June 2004 - June 2005
Thomas Ladisch Associates 1990 - 2000
Skills
Aseptic Processing, Change Control, Instrumentation, Process Control, Validation, AutoCAD, Facilities Management, Construction Management, GMP, Engineering, Commissioning, FDA, 21 CFR Part 11, Quality System, Biopharmaceuticals, Project Engineering, Process Engineering, Engineering Management, GAMP, HAZOP, Computer System..., Biotechnology, Quality Assurance, Chemical Engineering, Sop, V&V, Microsoft Office, Process Equipment, Process Simulation, Factory, SOP
Education
Penn State University 1995 — 1999
Bachelor of Science (BS), Chemical Engineering
Hyde Engineering + Consulting January 2015 - Present
ValSource, LLC August 2012 - December 2014
LifeTek Solutions June 2005 - August 2012
O'Brien & Gere June 2004 - June 2005
Thomas Ladisch Associates 1990 - 2000
Skills
Aseptic Processing, Change Control, Instrumentation, Process Control, Validation, AutoCAD, Facilities Management, Construction Management, GMP, Engineering, Commissioning, FDA, 21 CFR Part 11, Quality System, Biopharmaceuticals, Project Engineering, Process Engineering, Engineering Management, GAMP, HAZOP, Computer System..., Biotechnology, Quality Assurance, Chemical Engineering, Sop, V&V, Microsoft Office, Process Equipment, Process Simulation, Factory, SOP
Education
Penn State University 1995 — 1999
Bachelor of Science (BS), Chemical Engineering
Joe Yakobosky's ValSource, LLC Experience May 2002 - October 2004
Job Supply Execution Manager at Janssen, Pharmaceutical Companies of Johnson and Johnson
Industry Biotechnology
Experience
Janssen, Pharmaceutical Companies of Johnson and Johnson March 2014 - Present
Janssen-Cilag September 2010 - Present
Centocor - Johnson & Johnson December 2008 - September 2010
Centocor October 2004 - December 2008
ValSource, LLC May 2002 - October 2004
Merck 1995 - 2002
Skills
Protein Purification, Purification, Six Sigma, Process Improvement, Process Optimization, Process Validation, GMP, Validation, Biotechnology, Aseptic Processing, V&V, FDA, CAPA, Vaccines, Protein Chemistry, Cell Culture, Pharmaceutical Industry
Education
Penn State University 1981 — 1985
BS, Biology
Penn State University 1981 — 1985
Bachelor's degree, Biology - Human Physiology
Janssen, Pharmaceutical Companies of Johnson and Johnson March 2014 - Present
Janssen-Cilag September 2010 - Present
Centocor - Johnson & Johnson December 2008 - September 2010
Centocor October 2004 - December 2008
ValSource, LLC May 2002 - October 2004
Merck 1995 - 2002
Skills
Protein Purification, Purification, Six Sigma, Process Improvement, Process Optimization, Process Validation, GMP, Validation, Biotechnology, Aseptic Processing, V&V, FDA, CAPA, Vaccines, Protein Chemistry, Cell Culture, Pharmaceutical Industry
Education
Penn State University 1981 — 1985
BS, Biology
Penn State University 1981 — 1985
Bachelor's degree, Biology - Human Physiology
Meghan Brassel's ValSource, LLC Experience April 2002 - January 2005
Job Owner at Kinsale Consulting LLC
Industry Biotechnology
Experience
Regeneron Pharmaceuticals March 2008 - Present
Kinsale Consulting LLC January 2005 - Present
ValSource, LLC April 2002 - January 2005
AMRI November 2001 - April 2002
Skills
GMP
Education
State University of New York College at Plattsburgh 1994 — 1997
BS, Chemistry
Regeneron Pharmaceuticals March 2008 - Present
Kinsale Consulting LLC January 2005 - Present
ValSource, LLC April 2002 - January 2005
AMRI November 2001 - April 2002
Skills
GMP
Education
State University of New York College at Plattsburgh 1994 — 1997
BS, Chemistry
John LoPiccolo's ValSource, LLC Experience October 2009 - October 2011
Job Experienced Operations and Quality Systems Management Executive
Industry Pharmaceuticals
Experience
JTL Consulting Services Inc. March 2015 - Present
JTL Consulting Services Inc. December 2014 - Present
JTL Consulting Services, Inc. March 2009 - Present
JTL Consulting Services April 2014 - January 2015
McNeil Consumer Healthcare November 2011 - December 2014
ValSource LLC October 2009 - October 2011
Schering-Plough Research Institute August 2009 - October 2009
Isogen LLC March 2009 - July 2009
Citadel Services Group, LLC March 2007 - July 2009
Schering-Plough 2001 - 2008
Skills
GMP, Validation, Quality Assurance, FDA, CAPA, Quality System, Pharmaceutical Industry, Biotechnology, Manufacturing, Sop, 21 CFR Part 11, Cross-functional Team..., Change Control, V&V, Process Improvement, Project Management, Regulatory Affairs, Biopharmaceuticals, GxP, Lean Manufacturing, Computer System..., Medical Devices, Pharmaceutics, Strategy, Root Cause Analysis, Document Management, Quality Management, Operations Management, Team Building, Strategic Planning, Six Sigma, Process Simulation, Compliance, cGMP, Lifesciences, Quality Control, R&D, Pharmaceuticals, Business Process..., Strategic Thinking, ISO 13485, Problem Solving, Coaching, Pharmaceutical Packaging, Compliance Remediation, Biotechnology Industry, Consent Decree, Medical Device..., Management, Quality Auditing
Education
Quinnipiac University 1981 — 1985
BS International Business Marketing, International Business/Trade/Commerce
Jackson Memorial
JTL Consulting Services Inc. March 2015 - Present
JTL Consulting Services Inc. December 2014 - Present
JTL Consulting Services, Inc. March 2009 - Present
JTL Consulting Services April 2014 - January 2015
McNeil Consumer Healthcare November 2011 - December 2014
ValSource LLC October 2009 - October 2011
Schering-Plough Research Institute August 2009 - October 2009
Isogen LLC March 2009 - July 2009
Citadel Services Group, LLC March 2007 - July 2009
Schering-Plough 2001 - 2008
Skills
GMP, Validation, Quality Assurance, FDA, CAPA, Quality System, Pharmaceutical Industry, Biotechnology, Manufacturing, Sop, 21 CFR Part 11, Cross-functional Team..., Change Control, V&V, Process Improvement, Project Management, Regulatory Affairs, Biopharmaceuticals, GxP, Lean Manufacturing, Computer System..., Medical Devices, Pharmaceutics, Strategy, Root Cause Analysis, Document Management, Quality Management, Operations Management, Team Building, Strategic Planning, Six Sigma, Process Simulation, Compliance, cGMP, Lifesciences, Quality Control, R&D, Pharmaceuticals, Business Process..., Strategic Thinking, ISO 13485, Problem Solving, Coaching, Pharmaceutical Packaging, Compliance Remediation, Biotechnology Industry, Consent Decree, Medical Device..., Management, Quality Auditing
Education
Quinnipiac University 1981 — 1985
BS International Business Marketing, International Business/Trade/Commerce
Jackson Memorial
Todd Ditmore's ValSource, LLC Experience December 2008 - Present
Job Sr Validation Engineer at ValSource, LLC
Industry Pharmaceuticals
Experience
ValSource, LLC December 2008 - Present
Wyeth Biotech March 2005 - November 2008
Serentec 2002 - 2005
Cardinal Health 2004 - 2004
CRB Consulting Engineers 2000 - 2002
Skills
Aseptic Processing, GMP, Validation, Quality Control, Software Documentation, Engineering, FDA, V&V, Quality Assurance, CAPA, Computer System..., Sop, Cell Culture, Change Control, GxP, Biopharmaceuticals, Sterilization, USP, Pharmaceutical Industry, Clean Rooms, Biotechnology, SOP, Vaccines
Education
Southern Polytechnic State University 1989 — 1992
BSIE, Industrial Engineering
ValSource, LLC December 2008 - Present
Wyeth Biotech March 2005 - November 2008
Serentec 2002 - 2005
Cardinal Health 2004 - 2004
CRB Consulting Engineers 2000 - 2002
Skills
Aseptic Processing, GMP, Validation, Quality Control, Software Documentation, Engineering, FDA, V&V, Quality Assurance, CAPA, Computer System..., Sop, Cell Culture, Change Control, GxP, Biopharmaceuticals, Sterilization, USP, Pharmaceutical Industry, Clean Rooms, Biotechnology, SOP, Vaccines
Education
Southern Polytechnic State University 1989 — 1992
BSIE, Industrial Engineering
Johnny Grimes's ValSource, LLC Experience August 2005 - October 2006
Job Software Quality Assurance
Industry Pharmaceuticals
Experience
Alkermes October 2006 - April 2014
ValSource, LLC August 2005 - October 2006
Self Employed April 2005 - August 2005
cGMP April 2001 - April 2005
Control Engineering, Inc. May 1997 - October 1999
Skills
Change Control, Validation, Computer System..., 21 CFR Part 11, Quality Assurance, Regulatory Affairs, CAPA, Biotechnology, Quality Auditing, GMP, LIMS, Quality System, Medical Devices, Quality Control, Pharmaceutical Industry, FDA, Aseptic Processing, GxP, V&V, GLP, Lifesciences, Software Documentation, Sop, Technology Transfer, Process Simulation, GAMP, Biopharmaceuticals
Education
University of Phoenix 2003 — 2003
Business
Mesa Community College 1981 — 1984
Welding, Mechanic, Hyd / Pneu Properities
San Juan Community College 1983 — 1983
Welding, Drafting
Intense School
Alkermes October 2006 - April 2014
ValSource, LLC August 2005 - October 2006
Self Employed April 2005 - August 2005
cGMP April 2001 - April 2005
Control Engineering, Inc. May 1997 - October 1999
Skills
Change Control, Validation, Computer System..., 21 CFR Part 11, Quality Assurance, Regulatory Affairs, CAPA, Biotechnology, Quality Auditing, GMP, LIMS, Quality System, Medical Devices, Quality Control, Pharmaceutical Industry, FDA, Aseptic Processing, GxP, V&V, GLP, Lifesciences, Software Documentation, Sop, Technology Transfer, Process Simulation, GAMP, Biopharmaceuticals
Education
University of Phoenix 2003 — 2003
Business
Mesa Community College 1981 — 1984
Welding, Mechanic, Hyd / Pneu Properities
San Juan Community College 1983 — 1983
Welding, Drafting
Intense School
Robert Wissert's ValSource, LLC Experience September 2006 - Present
Job Pharmaceutical Consultant
Industry Pharmaceuticals
Experience
ValSource, LLC September 2006 - Present
Day & Zimmermann June 2003 - September 2006
Washington Group International July 2000 - June 2003
Wyeth September 1986 - July 2000
Skills
Change Control, GMP, Validation, 21 CFR Part 11, V&V, FDA, GxP, Computer System..., Cleaning Validation, Biopharmaceuticals, Sop, Biotechnology, Quality System, GAMP, Technology Transfer, Pharmaceutical Industry, LIMS, CAPA, Quality Control, Quality Assurance, GLP, Aseptic Processing, ISO 13485, Vaccines, Pharmaceutics, Regulatory Affairs, Medical Devices, Protocol, Manufacturing, Lifesciences, Regulatory Requirements, Process Simulation, Regulatory Submissions, Quality Auditing, Trackwise, Sterilization, Document Management, Root Cause Analysis, R&D, GCP, Calibration, Minitab, Chromatography, HPLC, Clinical Development, Clinical Trials, CRO, Analytical Chemistry, Cross-functional Team..., SOP
Education
Temple University 2015 — 2017
Master's degree, Quality Assurance / Regulatory Affairs
Immaculata University
BA, Business Management
Villanova University 2010 — 2011
Six Sigma
ValSource, LLC September 2006 - Present
Day & Zimmermann June 2003 - September 2006
Washington Group International July 2000 - June 2003
Wyeth September 1986 - July 2000
Skills
Change Control, GMP, Validation, 21 CFR Part 11, V&V, FDA, GxP, Computer System..., Cleaning Validation, Biopharmaceuticals, Sop, Biotechnology, Quality System, GAMP, Technology Transfer, Pharmaceutical Industry, LIMS, CAPA, Quality Control, Quality Assurance, GLP, Aseptic Processing, ISO 13485, Vaccines, Pharmaceutics, Regulatory Affairs, Medical Devices, Protocol, Manufacturing, Lifesciences, Regulatory Requirements, Process Simulation, Regulatory Submissions, Quality Auditing, Trackwise, Sterilization, Document Management, Root Cause Analysis, R&D, GCP, Calibration, Minitab, Chromatography, HPLC, Clinical Development, Clinical Trials, CRO, Analytical Chemistry, Cross-functional Team..., SOP
Education
Temple University 2015 — 2017
Master's degree, Quality Assurance / Regulatory Affairs
Immaculata University
BA, Business Management
Villanova University 2010 — 2011
Six Sigma
Michael Borgesi's ValSource, LLC Experience March 2013 - Present
Job CQV Project Manager at ValSource, LLC
Industry Pharmaceuticals
Experience
ValSource, LLC March 2013 - Present
Biopharm Pro May 2010 - October 2014
Morphotek 2010 - 2013
ValSource, LLC February 2009 - April 2010
Merck 2009 - 2010
CTG, Inc. 2005 - 2009
Compliance Technology Group, Inc. 2005 - 2009
Sanofi Pasteur 2008 - 2008
ValSource, LLC October 1996 - May 2005
Centocor 2002 - 2004
Skills
GAMP, 21 CFR Part 11, Change Control, Quality Assurance, GMP, Computer System..., FDA, V&V, Cleaning Validation, Validation, CAPA, Technology Transfer, Quality System, GxP, Pharmaceutical Industry, Manufacturing, Document Management, Sop, Quality Control, Biotechnology, Biopharmaceuticals, Medical Devices, Software Documentation, Testing, Lifesciences, Automation, Process Simulation, Regulatory Requirements, Quality Auditing, Aseptic Processing
Education
Temple University 1984 — 1986
Architecture
ValSource, LLC March 2013 - Present
Biopharm Pro May 2010 - October 2014
Morphotek 2010 - 2013
ValSource, LLC February 2009 - April 2010
Merck 2009 - 2010
CTG, Inc. 2005 - 2009
Compliance Technology Group, Inc. 2005 - 2009
Sanofi Pasteur 2008 - 2008
ValSource, LLC October 1996 - May 2005
Centocor 2002 - 2004
Skills
GAMP, 21 CFR Part 11, Change Control, Quality Assurance, GMP, Computer System..., FDA, V&V, Cleaning Validation, Validation, CAPA, Technology Transfer, Quality System, GxP, Pharmaceutical Industry, Manufacturing, Document Management, Sop, Quality Control, Biotechnology, Biopharmaceuticals, Medical Devices, Software Documentation, Testing, Lifesciences, Automation, Process Simulation, Regulatory Requirements, Quality Auditing, Aseptic Processing
Education
Temple University 1984 — 1986
Architecture
Brian Snyder's ValSource, LLC Experience May 2010 - May 2012
Job Senior Process Engineer at IPSIntegrated Project Services, Inc.
Industry Pharmaceuticals
Experience
IPS-Integrated Project Services, Inc. January 2015 - Present
Integrated Project Services May 2012 - Present
McNeil Consumer Healthcare 2012 - 2015
McNeil Consumer Healthcare 2012 - 2015
ValSource, LLC May 2010 - May 2012
Merck 2010 - May 2012
AMEC December 2007 - May 2010
BMS November 2009 - April 2010
Rowan University September 2009 - December 2009
Jacobs Engineering January 2007 - December 2007
Skills
GMP, Pharmaceutical Industry, Biotechnology, Validation, V&V, Process Engineering, Aseptic Processing, Quality Control, Medical Devices, Cleaning Validation, Purification, Change Control, Vaccines, CAPA, Manufacturing, FDA, Process Simulation
Education
Temple University 2001 — 2004
Basic Study Drug Development Certification, Quality Assurance and Regulatory Affairs
Bucknell University 1989 — 1993
B.S., Chemical Engineering
IPS-Integrated Project Services, Inc. January 2015 - Present
Integrated Project Services May 2012 - Present
McNeil Consumer Healthcare 2012 - 2015
McNeil Consumer Healthcare 2012 - 2015
ValSource, LLC May 2010 - May 2012
Merck 2010 - May 2012
AMEC December 2007 - May 2010
BMS November 2009 - April 2010
Rowan University September 2009 - December 2009
Jacobs Engineering January 2007 - December 2007
Skills
GMP, Pharmaceutical Industry, Biotechnology, Validation, V&V, Process Engineering, Aseptic Processing, Quality Control, Medical Devices, Cleaning Validation, Purification, Change Control, Vaccines, CAPA, Manufacturing, FDA, Process Simulation
Education
Temple University 2001 — 2004
Basic Study Drug Development Certification, Quality Assurance and Regulatory Affairs
Bucknell University 1989 — 1993
B.S., Chemical Engineering
Jomar Camacho Collazo's ValSource, LLC Experience April 2012 - Present
Job Validation Engineer at ValSource, LLC
Industry Pharmaceuticals
Experience
ValSource, LLC April 2012 - Present
ValSource, LLC May 2011 - March 2012
ValSource, LLC June 2010 - April 2011
Idaive Contractor Inc. January 2010 - April 2010
Aireko Construction June 2007 - August 2007
Bermudes y Longo. May 2006 - August 2006
Skills
21 CFR Part 11, Validation, cGMP, Engineering, Commissioning, FDA, Medical Devices, Pharmaceuticals, Technical Writing, Excel, Microsoft Office, Word, Estimates, Project Management, P&ID, Photography, Pharmaceutical Industry, GMP
Education
University of Puerto Rico 2002 — 2008
BSCE, Civil Engineer
University of Puerto Rico-Mayaguez 2002 — 2008
Certificate, Project Management, Aquired
ValSource, LLC April 2012 - Present
ValSource, LLC May 2011 - March 2012
ValSource, LLC June 2010 - April 2011
Idaive Contractor Inc. January 2010 - April 2010
Aireko Construction June 2007 - August 2007
Bermudes y Longo. May 2006 - August 2006
Skills
21 CFR Part 11, Validation, cGMP, Engineering, Commissioning, FDA, Medical Devices, Pharmaceuticals, Technical Writing, Excel, Microsoft Office, Word, Estimates, Project Management, P&ID, Photography, Pharmaceutical Industry, GMP
Education
University of Puerto Rico 2002 — 2008
BSCE, Civil Engineer
University of Puerto Rico-Mayaguez 2002 — 2008
Certificate, Project Management, Aquired
Collin Wyse's ValSource, LLC Experience January 2010 - Present
Job Project Manager at ValSource, LLC
Industry Pharmaceuticals
Experience
ValSource, LLC January 2010 - Present
ValSource, LLC March 2006 - Present
ValSource, LLC June 2004 - March 2006
Skills
GMP
Education
Rose-Hulman Institute of Technology 2001 — 2004
Bachelor of Science (BS), Chemical Engineering
Hesston College 1999 — 2001
Associate of Arts and Sciences (AAS)
ValSource, LLC January 2010 - Present
ValSource, LLC March 2006 - Present
ValSource, LLC June 2004 - March 2006
Skills
GMP
Education
Rose-Hulman Institute of Technology 2001 — 2004
Bachelor of Science (BS), Chemical Engineering
Hesston College 1999 — 2001
Associate of Arts and Sciences (AAS)
Robert Mercado's ValSource, LLC Experience August 2010 - Present
Job Validation Consultant
Industry Pharmaceuticals
Experience
ValSource, LLC August 2010 - Present
Professional Validation Group November 2004 - July 2010
High Tech Engineering January 2002 - July 2004
National Standards of PR February 2000 - December 2001
High Tech Engineering May 1997 - January 2000
Skills
Validation, CAPA, FDA
Education
Politechnic University of Puerto Rico 2005 — 2007
Masters, Pharmaceutical Technology
University of Puerto Rico 1993 — 1997
Bachelor, Science of Electronic Engineering Technology
ValSource, LLC August 2010 - Present
Professional Validation Group November 2004 - July 2010
High Tech Engineering January 2002 - July 2004
National Standards of PR February 2000 - December 2001
High Tech Engineering May 1997 - January 2000
Skills
Validation, CAPA, FDA
Education
Politechnic University of Puerto Rico 2005 — 2007
Masters, Pharmaceutical Technology
University of Puerto Rico 1993 — 1997
Bachelor, Science of Electronic Engineering Technology
Dipti Amin's ValSource, LLC Experience August 2014 - Present
Job Validation Specialist at ValSource, LLC
Industry Biotechnology
Experience
ValSource, LLC August 2014 - Present
Genzyme Biologics July 2013 - July 2014
G R Validation and Compliance Services September 2011 - July 2013
PCI Synthesis July 2011 - September 2011
Skills
Microsoft Office, Customer Service, Microsoft Excel, Management, Microsoft Word, PowerPoint, Public Speaking, Research, Project Management, Leadership
Education
Stevens Institute of Technology 2008 — 2010
Master's degree, Pharmaceutical Sciences
Stevens Institute of Technology 2008 — 2010
Master's degree, Pharmaceutical Sciences
ValSource, LLC August 2014 - Present
Genzyme Biologics July 2013 - July 2014
G R Validation and Compliance Services September 2011 - July 2013
PCI Synthesis July 2011 - September 2011
Skills
Microsoft Office, Customer Service, Microsoft Excel, Management, Microsoft Word, PowerPoint, Public Speaking, Research, Project Management, Leadership
Education
Stevens Institute of Technology 2008 — 2010
Master's degree, Pharmaceutical Sciences
Stevens Institute of Technology 2008 — 2010
Master's degree, Pharmaceutical Sciences
Alana Chiampi's ValSource, LLC Experience March 2012 - August 2013
Job Masters Student, Teaching Assistant Microbiology
Industry Research
Experience
ValSource, LLC March 2012 - August 2013
Sanofi Pasteur November 2010 - March 2012
Skills
Validation, Cleaning Validation, Computer System..., 21 CFR Part 11, GMP, Change Control, Sop, V&V, Aseptic Processing, CAPA, Quality System, GAMP, Process Simulation, Quality Assurance, Pharmaceutical Industry, Medical Devices, FDA, Biopharmaceuticals, GLP, SOP
Education
Saint Joseph's University 2006 — 2010
Bachelor of Science (BS), Chemical Biology
California State University-Long Beach
Master's degree, Microbiology
ValSource, LLC March 2012 - August 2013
Sanofi Pasteur November 2010 - March 2012
Skills
Validation, Cleaning Validation, Computer System..., 21 CFR Part 11, GMP, Change Control, Sop, V&V, Aseptic Processing, CAPA, Quality System, GAMP, Process Simulation, Quality Assurance, Pharmaceutical Industry, Medical Devices, FDA, Biopharmaceuticals, GLP, SOP
Education
Saint Joseph's University 2006 — 2010
Bachelor of Science (BS), Chemical Biology
California State University-Long Beach
Master's degree, Microbiology
Michael Kropp's ValSource, LLC Experience November 2010 - Present
Job Validation Specialist at ValSource, LLC
Industry Pharmaceuticals
Experience
ValSource, LLC November 2010 - Present
Skills
Validation, Equipment Qualification, Pharmaceutical Industry, Quality Assurance, Process Validation, Document Management, GMP, Sop, Trackwise, FDA, Politics, Political Science, Political Philosophy, Autoclave, Quality System, CAPA, Equipment Commissioning, Protocol Development
Education
Rutgers, The State University of New Jersey-New Brunswick
Bachelor of Arts (B.A.), Political Science (Major), Psychology (Minor)
ValSource, LLC November 2010 - Present
Skills
Validation, Equipment Qualification, Pharmaceutical Industry, Quality Assurance, Process Validation, Document Management, GMP, Sop, Trackwise, FDA, Politics, Political Science, Political Philosophy, Autoclave, Quality System, CAPA, Equipment Commissioning, Protocol Development
Education
Rutgers, The State University of New Jersey-New Brunswick
Bachelor of Arts (B.A.), Political Science (Major), Psychology (Minor)
Mike Proulx's ValSource, LLC Experience May 2006 - Present
Job Biotech Consultant at ValSource, LLC
Industry Pharmaceuticals
Experience
ValSource, LLC May 2006 - Present
Biogen Idec 2010 - 2012
Abbott 2008 - 2010
Lonza September 2004 - May 2006
Skills
Computer System..., 21 CFR Part 11, GxP, Validation, Change Control, GAMP, Pharmaceutical Industry, GMP, Cleaning Validation, V&V, FDA, Aseptic Processing, Sop, CAPA, Biotechnology, LIMS, Biopharmaceuticals, Lifesciences, Technology Transfer
Education
Fitchburg State College 1995 — 2001
BS, Clinical Laboratory Science/Medical Technology/Technologist
ValSource, LLC May 2006 - Present
Biogen Idec 2010 - 2012
Abbott 2008 - 2010
Lonza September 2004 - May 2006
Skills
Computer System..., 21 CFR Part 11, GxP, Validation, Change Control, GAMP, Pharmaceutical Industry, GMP, Cleaning Validation, V&V, FDA, Aseptic Processing, Sop, CAPA, Biotechnology, LIMS, Biopharmaceuticals, Lifesciences, Technology Transfer
Education
Fitchburg State College 1995 — 2001
BS, Clinical Laboratory Science/Medical Technology/Technologist
Stephanie Kromer's ValSource, LLC Experience October 2002 - August 2007
Job Senior Manager, Sales Development at Fujifilm Diosynth Biotechnologies
Industry Biotechnology
Experience
Fujifilm Diosynth Biotechnologies January 2014 - Present
Fujifilm Diosynth Biotechnologies April 2013 - January 2014
Fujifilm Diosynth Biotechnologies August 2008 - April 2013
Compliance Technology Group Inc. August 2007 - August 2008
ValSource, LLC October 2002 - August 2007
Genyzme Corporation August 1997 - December 1999
Organogenesis September 1993 - August 1997
Skills
R&D, V&V, 21 CFR Part 11, GMP, Biopharmaceuticals, Validation, GxP, FDA, Sop, Aseptic Processing, Change Control, Computer System..., CAPA, LIMS, GLP, Biotechnology
Education
Lehigh University 2000 — 2001
Master of Business Administration (MBA)
Ursinus College 1989 — 1993
B.S., Biology
Fujifilm Diosynth Biotechnologies January 2014 - Present
Fujifilm Diosynth Biotechnologies April 2013 - January 2014
Fujifilm Diosynth Biotechnologies August 2008 - April 2013
Compliance Technology Group Inc. August 2007 - August 2008
ValSource, LLC October 2002 - August 2007
Genyzme Corporation August 1997 - December 1999
Organogenesis September 1993 - August 1997
Skills
R&D, V&V, 21 CFR Part 11, GMP, Biopharmaceuticals, Validation, GxP, FDA, Sop, Aseptic Processing, Change Control, Computer System..., CAPA, LIMS, GLP, Biotechnology
Education
Lehigh University 2000 — 2001
Master of Business Administration (MBA)
Ursinus College 1989 — 1993
B.S., Biology
Djonaldo Misa's ValSource, LLC Experience January 2009 - April 2011
Job Validation / Quality Assurance
Industry Biotechnology
Experience
Validation Technologies, Inc. April 2012 - Present
N/A November 2011 - March 2012
Dendreon April 2011 - November 2011
ValSource, LLC January 2009 - April 2011
N/A January 2008 - December 2008
cGMP Validation LLC December 2003 - December 2007
Skills
Change Control, FDA, Biopharmaceuticals, GAMP, Validation, 21 CFR Part 11, GMP
Education
Rutgers, The State University of New Jersey-New Brunswick
Bachelor's degree
Validation Technologies, Inc. April 2012 - Present
N/A November 2011 - March 2012
Dendreon April 2011 - November 2011
ValSource, LLC January 2009 - April 2011
N/A January 2008 - December 2008
cGMP Validation LLC December 2003 - December 2007
Skills
Change Control, FDA, Biopharmaceuticals, GAMP, Validation, 21 CFR Part 11, GMP
Education
Rutgers, The State University of New Jersey-New Brunswick
Bachelor's degree
Hussein Syed, M.S.'s ValSource, LLC Experience May 2014 - Present
Job Commissioning Engineer at ValSource, LLC
Industry Biotechnology
Experience
ValSource, LLC May 2014 - Present
DPS Engineering November 2013 - April 2014
Genzyme March 2013 - October 2013
Cambridge Biomedical Inc. April 2012 - February 2013
Beth Israel Deaconess Medical Center March 2010 - March 2012
Boston Medical Center November 2009 - March 2010
Genzyme Biosurgery May 2008 - June 2009
Boston University School of Medicine, Department of Dermatology May 2007 - May 2008
Skills
ELISA, GLP, GCP, Cell Culture, Biotechnology, Molecular Biology, Validation, FDA, GxP, GMP, 21 CFR Part 11, Good Documentation..., Soft Skills, assay development, Project management, Kaye Validator 2000, Palltronic Flowstar IV...
Education
Northeastern University 2012 — 2014
Masters of Science, Regulatory Affairs
Boston University School of Medicine 2008 — 2012
Bachelors of Science (BS), Biomedical Laboratory and Clinical Sciences
ValSource, LLC May 2014 - Present
DPS Engineering November 2013 - April 2014
Genzyme March 2013 - October 2013
Cambridge Biomedical Inc. April 2012 - February 2013
Beth Israel Deaconess Medical Center March 2010 - March 2012
Boston Medical Center November 2009 - March 2010
Genzyme Biosurgery May 2008 - June 2009
Boston University School of Medicine, Department of Dermatology May 2007 - May 2008
Skills
ELISA, GLP, GCP, Cell Culture, Biotechnology, Molecular Biology, Validation, FDA, GxP, GMP, 21 CFR Part 11, Good Documentation..., Soft Skills, assay development, Project management, Kaye Validator 2000, Palltronic Flowstar IV...
Education
Northeastern University 2012 — 2014
Masters of Science, Regulatory Affairs
Boston University School of Medicine 2008 — 2012
Bachelors of Science (BS), Biomedical Laboratory and Clinical Sciences
Whitney Kutney's ValSource, LLC Experience January 2007 - Present
Job Southeast Regional Manager at ValSource, LLC
Industry Pharmaceuticals
Experience
ValSource, LLC January 2007 - Present
Skills
Biotechnology, Cross-functional Team..., FDA, Lifesciences, Manufacturing, Medical Devices, Pharmaceutical Industry, Process Control, Quality Assurance, Six Sigma, Quality Control, Computer System..., GMP, Validation, CAPA
Education
University of Notre Dame 1998 — 2002
Bachelor of Science (BS), Chemical Engineering
ValSource, LLC January 2007 - Present
Skills
Biotechnology, Cross-functional Team..., FDA, Lifesciences, Manufacturing, Medical Devices, Pharmaceutical Industry, Process Control, Quality Assurance, Six Sigma, Quality Control, Computer System..., GMP, Validation, CAPA
Education
University of Notre Dame 1998 — 2002
Bachelor of Science (BS), Chemical Engineering
Quy Le's ValSource, LLC Experience June 2000 - May 2014
Job Validation Engineer at J&J McNeil
Industry Pharmaceuticals
Experience
Consulting at J&J McNeil June 2014 - Present
ValSource, LLC June 2000 - May 2014
ValSource, LLC June 2000 - May 2013
IPS November 1999 - May 2000
VPA June 1999 - November 1999
Skills
Validation, 21 CFR Part 11, Change Control, Computer System..., V&V, CAPA, GMP, GxP, Cleaning Validation, FDA, Sop, GAMP, Aseptic Processing, Quality System, LIMS
Education
Penn State University 1996 — 1999
Bachelor of Science (BS), Chemical Engineering
Consulting at J&J McNeil June 2014 - Present
ValSource, LLC June 2000 - May 2014
ValSource, LLC June 2000 - May 2013
IPS November 1999 - May 2000
VPA June 1999 - November 1999
Skills
Validation, 21 CFR Part 11, Change Control, Computer System..., V&V, CAPA, GMP, GxP, Cleaning Validation, FDA, Sop, GAMP, Aseptic Processing, Quality System, LIMS
Education
Penn State University 1996 — 1999
Bachelor of Science (BS), Chemical Engineering