CSSC Company
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CSSC Employees
Employee
Years
Job
Industry
Jacob Katz Jacob Katz's CSSC Experience October 1998 - Present
Job Senior Consultant at CSSC
Industry Financial Services
Experience
CSSC October 1998 - Present
IBM September 1995 - May 1996
Skills
Investments, Mentoring Of Staff, Resource Management, Financial Analysis, Estate Planning, Marketing Strategy, Strategic Financial..., Management, Entrepreneurship, Start-ups, Finance, Asset Management, Analysis, Public Speaking, Risk Management, Strategy, Management Consulting, Financial Modeling, Mergers & Acquisitions, Business Process..., Leadership, Strategic Planning, Sales, Process Improvement, Change Management
Education
Walsh College 2014 — 2015
Masters of Science in Finance, Finance, 3.7
Walsh College 2012 — 2014
Master of Business Administration (MBA), Finance, 3.85
Michigan State University 1991 — 1995
BA, International Relations
Cros-Lex High School
CSSC October 1998 - Present
IBM September 1995 - May 1996
Skills
Investments, Mentoring Of Staff, Resource Management, Financial Analysis, Estate Planning, Marketing Strategy, Strategic Financial..., Management, Entrepreneurship, Start-ups, Finance, Asset Management, Analysis, Public Speaking, Risk Management, Strategy, Management Consulting, Financial Modeling, Mergers & Acquisitions, Business Process..., Leadership, Strategic Planning, Sales, Process Improvement, Change Management
Education
Walsh College 2014 — 2015
Masters of Science in Finance, Finance, 3.7
Walsh College 2012 — 2014
Master of Business Administration (MBA), Finance, 3.85
Michigan State University 1991 — 1995
BA, International Relations
Cros-Lex High School
Ellis Daw Ellis Daw's CSSC Experience 1994 - 1994
Job Director, Quality Technology and Projects at GlaxoSmithKline
Industry Pharmaceuticals
Experience
GlaxoSmithKline January 2011 - Present
ISPE 1998 - Present
GlaxoSmithKline January 2009 - December 2010
GlaxoSmithKline June 2005 - December 2008
Burroughs Wellcome 1985 - 1996
Burroughs Wellcome 1985 - 1996
CSSC 1994 - 1994
Skills
Change Control, Training, Business Process, Validation, Quality Assurance, GMP, Pharmaceutical Industry, Management, 21 CFR Part 11, Computer System..., Change Management, FDA, CAPA, Software Documentation, Sop
Education
East Carolina University - College of Business 1987 — 1992
MBA, Business
East Carolina University 1982 — 1985
Bachelors, Computer Science
Belhaven 1977 — 1979
GlaxoSmithKline January 2011 - Present
ISPE 1998 - Present
GlaxoSmithKline January 2009 - December 2010
GlaxoSmithKline June 2005 - December 2008
Burroughs Wellcome 1985 - 1996
Burroughs Wellcome 1985 - 1996
CSSC 1994 - 1994
Skills
Change Control, Training, Business Process, Validation, Quality Assurance, GMP, Pharmaceutical Industry, Management, 21 CFR Part 11, Computer System..., Change Management, FDA, CAPA, Software Documentation, Sop
Education
East Carolina University - College of Business 1987 — 1992
MBA, Business
East Carolina University 1982 — 1985
Bachelors, Computer Science
Belhaven 1977 — 1979
Alexis Stroud Alexis Stroud's CSSC Experience February 2000 - February 2005
Job Associate Director, Corporate Compliance; CQA
Industry Pharmaceuticals
Experience
Healthcare Businesswomen’s Association September 2015 - Present
Purdue November 2011 - Present
Healthcare Businesswomen's Association January 2013 - September 2015
QPharma, Inc. August 2010 - October 2011
QPharma, Inc. February 2005 - August 2010
Integrated Pharma Technologies February 2005 - February 2008
CSSC February 2000 - February 2005
Rutgers Cognitive Development Lab 1997 - 1999
Skills
SOP development, Training, Regulatory Audits, 21 CFR Part 11, Quality System, Computer System..., Software Documentation, FDA, Regulatory Affairs, CAPA, Sop, Change Control, Quality Auditing, Pharmaceutical Industry, Regulatory Requirements, GAMP, GxP, SDLC, Aggregate Spend, Validation, GMP, Document Management, Project Management, Auditing, Quality Assurance, Process Improvement, V&V, Clinical Trials, GLP, Regulatory Submissions, LIMS, Biotechnology, ISO 13485, GCP, Biopharmaceuticals, Technology Transfer, Medical Devices, SOP, Lifesciences, Pharmacovigilance, Life Sciences
Education
Seton Hall Law School
Healthcare Compliance
Fairleigh Dickinson University 2000 — 2005
MBA, Pharmaceutical Management
Rutgers, The State University of New Jersey-New Brunswick 1995 — 2000
BA, Psychology and Sociology
Healthcare Businesswomen’s Association September 2015 - Present
Purdue November 2011 - Present
Healthcare Businesswomen's Association January 2013 - September 2015
QPharma, Inc. August 2010 - October 2011
QPharma, Inc. February 2005 - August 2010
Integrated Pharma Technologies February 2005 - February 2008
CSSC February 2000 - February 2005
Rutgers Cognitive Development Lab 1997 - 1999
Skills
SOP development, Training, Regulatory Audits, 21 CFR Part 11, Quality System, Computer System..., Software Documentation, FDA, Regulatory Affairs, CAPA, Sop, Change Control, Quality Auditing, Pharmaceutical Industry, Regulatory Requirements, GAMP, GxP, SDLC, Aggregate Spend, Validation, GMP, Document Management, Project Management, Auditing, Quality Assurance, Process Improvement, V&V, Clinical Trials, GLP, Regulatory Submissions, LIMS, Biotechnology, ISO 13485, GCP, Biopharmaceuticals, Technology Transfer, Medical Devices, SOP, Lifesciences, Pharmacovigilance, Life Sciences
Education
Seton Hall Law School
Healthcare Compliance
Fairleigh Dickinson University 2000 — 2005
MBA, Pharmaceutical Management
Rutgers, The State University of New Jersey-New Brunswick 1995 — 2000
BA, Psychology and Sociology
Reginald Long Reginald Long's CSSC Experience 1984 - 1991
Job Recruitment and Worker Readiness Coord
Industry Nonprofit Organization Management
Experience
Better Futures Minnesota October 2014 - Present
Minnesota Twins April 2014 - Present
State of Minnesota 2007 - October 2014
Deans Foods 2005 - 2007
SuperValu 2000 - 2005
BJ’s & TJ’s Handy Services 1996 - 2000
Rodney D Young Agency 1992 - 1996
Rechord and Associates 1990 - 1992
CSSC 1984 - 1991
Morris Tiger Sharks 1985 - 1989
Skills
Leadership, Customer Service, Team Leadership, Management, Team Building, Microsoft Office, Microsoft Excel, Training, Research, Insurance, Security, Coaching, Government, Policy, Software Documentation, Time Management, Program Management, Sales, Nonprofits, Public Speaking, Community Outreach, Conflict Resolution, Leadership Development, Fundraising, Staff Development, Organizational...
Education
Walden University 2011 — 2014
Master of Business Administration (MBA), Human Resource Management
University of Minnesota-Morris
Bachelor of Arts (B.A.)
Whitney M Young Magnet H.S.
Better Futures Minnesota October 2014 - Present
Minnesota Twins April 2014 - Present
State of Minnesota 2007 - October 2014
Deans Foods 2005 - 2007
SuperValu 2000 - 2005
BJ’s & TJ’s Handy Services 1996 - 2000
Rodney D Young Agency 1992 - 1996
Rechord and Associates 1990 - 1992
CSSC 1984 - 1991
Morris Tiger Sharks 1985 - 1989
Skills
Leadership, Customer Service, Team Leadership, Management, Team Building, Microsoft Office, Microsoft Excel, Training, Research, Insurance, Security, Coaching, Government, Policy, Software Documentation, Time Management, Program Management, Sales, Nonprofits, Public Speaking, Community Outreach, Conflict Resolution, Leadership Development, Fundraising, Staff Development, Organizational...
Education
Walden University 2011 — 2014
Master of Business Administration (MBA), Human Resource Management
University of Minnesota-Morris
Bachelor of Arts (B.A.)
Whitney M Young Magnet H.S.
Bruce Fieggen Bruce Fieggen's CSSC Experience 2001 - 2006
Job Project Management Guru
Industry Pharmaceuticals
Experience
QPharma, Inc. January 2006 - Present
Cadence Management Corporation October 2001 - Present
Boston University Corporate Education Center September 2001 - Present
CSSC 2001 - 2006
Boston Scientific June 1997 - June 2001
Datascope February 1996 - June 1997
Boston Scientific/Northwest Technology Center June 1994 - February 1996
Quinton Instruments June 1993 - June 1994
Abbott Research Inc. January 1986 - May 1993
Skills
Project Management..., Rapid Project Startups, Resume Building, Social Networking, Start-ups, Project Management, PMO, Resume Writing, Rapid Prototyping, Program Management, MS Project, PMP, Medical Devices, Product Development, Process Improvement, Management, Leadership, Six Sigma, Change Control, Validation, Training, Cross-functional Team..., Team Leadership, FDA, V&V, CAPA, Project Portfolio..., Process Simulation, Quality Assurance, Biotechnology, Budgets, SDLC, Computer System..., GMP, 21 CFR Part 11, Manufacturing, Software Documentation, Lifesciences, Process Engineering, ISO 13485, Project Planning, R&D, Change Management, Healthcare, Engineering, CRM, Continuous Improvement, Microsoft Project, Humanitarian, Vendor Management
Education
University of Oregon 1980 — 1985
BA, Biochemistry
Project Management Institute 1998 — 1998
PMP, Project Management
Mordialloc College 1978 — 1978
High School Certificate, Math/Science
Bonbeach High School 1972 — 1977
Leaving Certificate, Math/Science
QPharma, Inc. January 2006 - Present
Cadence Management Corporation October 2001 - Present
Boston University Corporate Education Center September 2001 - Present
CSSC 2001 - 2006
Boston Scientific June 1997 - June 2001
Datascope February 1996 - June 1997
Boston Scientific/Northwest Technology Center June 1994 - February 1996
Quinton Instruments June 1993 - June 1994
Abbott Research Inc. January 1986 - May 1993
Skills
Project Management..., Rapid Project Startups, Resume Building, Social Networking, Start-ups, Project Management, PMO, Resume Writing, Rapid Prototyping, Program Management, MS Project, PMP, Medical Devices, Product Development, Process Improvement, Management, Leadership, Six Sigma, Change Control, Validation, Training, Cross-functional Team..., Team Leadership, FDA, V&V, CAPA, Project Portfolio..., Process Simulation, Quality Assurance, Biotechnology, Budgets, SDLC, Computer System..., GMP, 21 CFR Part 11, Manufacturing, Software Documentation, Lifesciences, Process Engineering, ISO 13485, Project Planning, R&D, Change Management, Healthcare, Engineering, CRM, Continuous Improvement, Microsoft Project, Humanitarian, Vendor Management
Education
University of Oregon 1980 — 1985
BA, Biochemistry
Project Management Institute 1998 — 1998
PMP, Project Management
Mordialloc College 1978 — 1978
High School Certificate, Math/Science
Bonbeach High School 1972 — 1977
Leaving Certificate, Math/Science
Rod Thorell's CSSC Experience 2005 - 2007
Job Sr. Product Manager at ERT Corporation
Industry Pharmaceuticals
Experience
ERT October 2012 - Present
PHT Corporation February 2009 - October 2012
PHT Corporation September 2007 - February 2009
PHT Corporation March 2007 - September 2007
CSSC 2005 - 2007
Mitochondrial Disease Action Committee 2004 - 2007
cGMP Validation 2002 - 2005
Waters Corporation 1986 - 1999
Skills
Quality Management, Computer System..., ISO, Continuous Improvement, auditing, Supplier Quality, Risk Management, Compliance, Quality Assurance, Software Quality..., SDLC, Agile Methodologies, GMP, GCP, GLP, ePRO, eClinical, EDC, EHR, Process Improvement, Cross-functional Team..., Auditing, Pharmaceutical Industry, Software Documentation, e-PRO, CRO, Quality System, 21 CFR Part 11, Change Control, Clinical Trials, Program Management, Testing, Regulatory Affairs, Validation, FDA, CAPA, Sop, Clinical Data Management, Medical Devices, Clinical Research, ISO 13485, CTMS, Data Management, Clinical Development, Biotechnology, Quality Control, Lifesciences, Process Simulation, SOP
Education
Bridgewater State University 1990 — 1995
ERT October 2012 - Present
PHT Corporation February 2009 - October 2012
PHT Corporation September 2007 - February 2009
PHT Corporation March 2007 - September 2007
CSSC 2005 - 2007
Mitochondrial Disease Action Committee 2004 - 2007
cGMP Validation 2002 - 2005
Waters Corporation 1986 - 1999
Skills
Quality Management, Computer System..., ISO, Continuous Improvement, auditing, Supplier Quality, Risk Management, Compliance, Quality Assurance, Software Quality..., SDLC, Agile Methodologies, GMP, GCP, GLP, ePRO, eClinical, EDC, EHR, Process Improvement, Cross-functional Team..., Auditing, Pharmaceutical Industry, Software Documentation, e-PRO, CRO, Quality System, 21 CFR Part 11, Change Control, Clinical Trials, Program Management, Testing, Regulatory Affairs, Validation, FDA, CAPA, Sop, Clinical Data Management, Medical Devices, Clinical Research, ISO 13485, CTMS, Data Management, Clinical Development, Biotechnology, Quality Control, Lifesciences, Process Simulation, SOP
Education
Bridgewater State University 1990 — 1995
Toni Carman's CSSC Experience October 2003 - September 2006
Job Associate Validation Manager at QPharma, Inc.
Industry Pharmaceuticals
Experience
QPharma, Inc. October 2012 - Present
QPharma, Inc. September 2003 - October 2012
CSSC October 2003 - September 2006
Skills
Pharmacovigilance, Document Management, CRM, Territory Management, 21 CFR Part 11, Validation, CAPA, FDA, GMP, Sop, Computer System..., Pharmaceutical Industry, SDLC, Software Documentation, Requirements Analysis, Testing, GxP, Change Control, Regulatory Affairs, Trackwise, Medical Devices, Quality System, ISO 13485, GLP, LIMS, Cleaning Validation, Quality Auditing, SOP, TrackWise
Education
East Stroudsburg University of Pennsylvania 1998 — 2001
QPharma, Inc. October 2012 - Present
QPharma, Inc. September 2003 - October 2012
CSSC October 2003 - September 2006
Skills
Pharmacovigilance, Document Management, CRM, Territory Management, 21 CFR Part 11, Validation, CAPA, FDA, GMP, Sop, Computer System..., Pharmaceutical Industry, SDLC, Software Documentation, Requirements Analysis, Testing, GxP, Change Control, Regulatory Affairs, Trackwise, Medical Devices, Quality System, ISO 13485, GLP, LIMS, Cleaning Validation, Quality Auditing, SOP, TrackWise
Education
East Stroudsburg University of Pennsylvania 1998 — 2001
Peter Munich Peter Munich's CSSC Experience 1999 - 2001
Job Data Center Operations at CompuCom
Industry Pharmaceuticals
Experience
CompuCom March 2011 - Present
Go2IT Group 2011 - May 2013
PROMOTECH - an inVentiv health company January 2008 - November 2010
CompuCom @ Pfizer October 2005 - February 2008
Pfizer October 2005 - February 2008
CompuCom December 2004 - October 2005
C3i 2002 - 2003
CSSC 1999 - 2001
Skills
Team Leadership, Pharmaceutical Industry, Account Management, CRM, Project Management, Business Analysis, Process Improvement, Software Documentation, Management, Sales Operations
Education
Centenary College 2006 — 2007
Morris Knolls
CompuCom March 2011 - Present
Go2IT Group 2011 - May 2013
PROMOTECH - an inVentiv health company January 2008 - November 2010
CompuCom @ Pfizer October 2005 - February 2008
Pfizer October 2005 - February 2008
CompuCom December 2004 - October 2005
C3i 2002 - 2003
CSSC 1999 - 2001
Skills
Team Leadership, Pharmaceutical Industry, Account Management, CRM, Project Management, Business Analysis, Process Improvement, Software Documentation, Management, Sales Operations
Education
Centenary College 2006 — 2007
Morris Knolls
Frederick H. Evans II Frederick H. Evans II's CSSC Experience 1992 - 2012
Job
Industry Staffing and Recruiting
Experience
Contract Head Swim CoachSouth Shore Internation College Prep2012 - 2013
CSSC 1992 - 2012
Targeted Search Services, LLC June 2005 - June 2009
Discover Financial Services 2005 - 2007
Braun Consulting and Fair Isaac now (FICO) June 2003 - May 2005
Strategic Search Services, Inc February 2002 - June 2003
Parallel Partners October 1994 - January 2001
Skills
Technical Recruiting, Recruiting, Executive Search, Sourcing, Vendor Management, Contract Recruitment, Program Management, Management, Business Development, Business Intelligence, Account Management, Team Leadership, Marketing, Hiring, Contract Negotiation
Education
St. John's College High School 1970 — 1974
Chicago State University
Master
Contract Head Swim CoachSouth Shore Internation College Prep2012 - 2013
CSSC 1992 - 2012
Targeted Search Services, LLC June 2005 - June 2009
Discover Financial Services 2005 - 2007
Braun Consulting and Fair Isaac now (FICO) June 2003 - May 2005
Strategic Search Services, Inc February 2002 - June 2003
Parallel Partners October 1994 - January 2001
Skills
Technical Recruiting, Recruiting, Executive Search, Sourcing, Vendor Management, Contract Recruitment, Program Management, Management, Business Development, Business Intelligence, Account Management, Team Leadership, Marketing, Hiring, Contract Negotiation
Education
St. John's College High School 1970 — 1974
Chicago State University
Master
Brendan Middleton Brendan Middleton's CSSC Experience 2001 - 2003
Job Director of Marketing and Public Relations at QPharma
Industry Pharmaceuticals
Experience
QPharma, Inc. January 2012 - Present
Saint Michael's Medical Center August 2004 - January 2012
SimStar 2003 - 2004
CSSC 2001 - 2003
ComLinx 1999 - 2001
Skills
Marketing Communications, Social Media, Media Relations, Healthcare, Strategic Planning, Marketing Strategy, Internal Communications, Newsletters, Email Marketing, Strategic Communications, Copywriting, Crisis Communications, Corporate Communications, Press Releases, Non-profits, Strategy, Fundraising, Brand Development, Social Networking, Digital Media, Online Marketing, Blogging, Program Development, Nonprofits, Community Outreach, Publicity, Publications
Education
Kean University
Bachelor of Arts
Millburn High School
QPharma, Inc. January 2012 - Present
Saint Michael's Medical Center August 2004 - January 2012
SimStar 2003 - 2004
CSSC 2001 - 2003
ComLinx 1999 - 2001
Skills
Marketing Communications, Social Media, Media Relations, Healthcare, Strategic Planning, Marketing Strategy, Internal Communications, Newsletters, Email Marketing, Strategic Communications, Copywriting, Crisis Communications, Corporate Communications, Press Releases, Non-profits, Strategy, Fundraising, Brand Development, Social Networking, Digital Media, Online Marketing, Blogging, Program Development, Nonprofits, Community Outreach, Publicity, Publications
Education
Kean University
Bachelor of Arts
Millburn High School
Elizabeth Fretz's CSSC Experience January 2002 - May 2003
Job FDA Compliance Analyst at Zimmerman Associates, Inc.
Industry Biotechnology
Experience
Zimmerman Associates, Inc. April 2014 - Present
Kelly Government Solutions June 2012 - July 2013
PKH Enterprises November 2008 - January 2012
American Red Cross April 2004 - July 2008
Executive Order, Inc. October 2003 - April 2004
CSSC January 2002 - May 2003
QualityWare, Inc. January 1994 - March 2002
Ortho Diagnostic Systems, Inc. December 1990 - October 1996
AT&T Communications October 1986 - December 1990
Skills
Quality Assurance, Program Management, FDA, Process Improvement, Government, Project Management, Medical Devices, CAPA, Healthcare, Validation, GMP, Management, Cross-functional Team..., Leadership, Regulatory Affairs, Strategy, Testing, Pharmaceutical Industry, Policy, Biotechnology, Business Development, Analysis, Change Control, Software Documentation, Manufacturing, Quality Control, Quality System, R&D, 21 CFR Part 11, Quality Auditing, Hardware Diagnostics, ISO 13485, V&V, Process Simulation, Lifesciences, Technology Transfer, Computer System..., Commercialization, Quality Management, Document Management, GLP
Education
Drew University
Bachelor of Arts (B.A.), Psychology
Hanover Park
Zimmerman Associates, Inc. April 2014 - Present
Kelly Government Solutions June 2012 - July 2013
PKH Enterprises November 2008 - January 2012
American Red Cross April 2004 - July 2008
Executive Order, Inc. October 2003 - April 2004
CSSC January 2002 - May 2003
QualityWare, Inc. January 1994 - March 2002
Ortho Diagnostic Systems, Inc. December 1990 - October 1996
AT&T Communications October 1986 - December 1990
Skills
Quality Assurance, Program Management, FDA, Process Improvement, Government, Project Management, Medical Devices, CAPA, Healthcare, Validation, GMP, Management, Cross-functional Team..., Leadership, Regulatory Affairs, Strategy, Testing, Pharmaceutical Industry, Policy, Biotechnology, Business Development, Analysis, Change Control, Software Documentation, Manufacturing, Quality Control, Quality System, R&D, 21 CFR Part 11, Quality Auditing, Hardware Diagnostics, ISO 13485, V&V, Process Simulation, Lifesciences, Technology Transfer, Computer System..., Commercialization, Quality Management, Document Management, GLP
Education
Drew University
Bachelor of Arts (B.A.), Psychology
Hanover Park
Anne DeMartino's CSSC Experience 2001 - 2003
Job Pharmaceuticals Professional
Industry Pharmaceuticals
Experience
Luitpold Pharmaceuticals March 2012 - Present
Contract Pharmacal Corp December 2010 - March 2012
cGMP Validation LLC June 2009 - May 2011
Bristol-Myers Squibb December 2007 - June 2009
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company September 2005 - August 2007
Medarex January 2005 - June 2005
Johnson Controls August 2003 - August 2004
CSSC 2001 - 2003
Merck 2000 - 2001
Colgate Palmolive 1999 - 2000
Skills
Change Control, Validation, Process Improvement, GMP, CAPA, FDA, 21 CFR Part 11, Sop, Cleaning Validation, Quality System, Computer System..., Quality Assurance, Biopharmaceuticals, Pharmaceutical Industry, Biotechnology, Aseptic Processing, GAMP, Quality Control
Education
Stevens Institute of Technology
Engineer's Degree, Chemical Engineering
Luitpold Pharmaceuticals March 2012 - Present
Contract Pharmacal Corp December 2010 - March 2012
cGMP Validation LLC June 2009 - May 2011
Bristol-Myers Squibb December 2007 - June 2009
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company September 2005 - August 2007
Medarex January 2005 - June 2005
Johnson Controls August 2003 - August 2004
CSSC 2001 - 2003
Merck 2000 - 2001
Colgate Palmolive 1999 - 2000
Skills
Change Control, Validation, Process Improvement, GMP, CAPA, FDA, 21 CFR Part 11, Sop, Cleaning Validation, Quality System, Computer System..., Quality Assurance, Biopharmaceuticals, Pharmaceutical Industry, Biotechnology, Aseptic Processing, GAMP, Quality Control
Education
Stevens Institute of Technology
Engineer's Degree, Chemical Engineering
Tammi Hill's CSSC Experience June 2003 - March 2005
Job QA Validation Specialist II at McNeil Consumer Healthcare
Industry Pharmaceuticals
Experience
McNeil Consumer Healthcare October 2011 - Present
Sceptre Innovative Solutions July 2008 - October 2011
Bloomberg 2007 - July 2008
Wyeth March 2005 - October 2007
CSSC June 2003 - March 2005
PS&S April 2001 - June 2003
Acid-Amine Technologies December 1997 - February 2001
Skills
HVAC, Validation, Quality Assurance, SOP, Sop
Education
New Jersey Institute of Technology 2009 — 2011
BS, Mechanical Engineering
New Jersey Institute of Technology 2000 — 2003
BSME, Mechanical Engineering
McNeil Consumer Healthcare October 2011 - Present
Sceptre Innovative Solutions July 2008 - October 2011
Bloomberg 2007 - July 2008
Wyeth March 2005 - October 2007
CSSC June 2003 - March 2005
PS&S April 2001 - June 2003
Acid-Amine Technologies December 1997 - February 2001
Skills
HVAC, Validation, Quality Assurance, SOP, Sop
Education
New Jersey Institute of Technology 2009 — 2011
BS, Mechanical Engineering
New Jersey Institute of Technology 2000 — 2003
BSME, Mechanical Engineering
Lana Cherny's CSSC Experience March 2006 - April 2008
Job CSV at Impax
Industry Information Technology and Services
Experience
Impax Laboratories August 2013 - Present
Johnson & Johnson March 2012 - August 2013
Novartis Institutes for Biomedical Research (NIBR) January 2011 - February 2012
Catalent Inc October 2010 - February 2011
SDLC Consulting Inc April 2008 - February 2011
Pfizer May 2008 - May 2009
CSSC March 2006 - April 2008
Taratec Development Corporation October 1998 - March 2006
Skills
Validation, GxP, Computer System..., FDA, V&V, 21 CFR Part 11, Sop
Education
Mendeleyev University of Chemical Technology of Russia 1986 — 1986
MS, Chemical Technology
Moscow State University of Food Production (MGUPP) 1978 — 1983
Impax Laboratories August 2013 - Present
Johnson & Johnson March 2012 - August 2013
Novartis Institutes for Biomedical Research (NIBR) January 2011 - February 2012
Catalent Inc October 2010 - February 2011
SDLC Consulting Inc April 2008 - February 2011
Pfizer May 2008 - May 2009
CSSC March 2006 - April 2008
Taratec Development Corporation October 1998 - March 2006
Skills
Validation, GxP, Computer System..., FDA, V&V, 21 CFR Part 11, Sop
Education
Mendeleyev University of Chemical Technology of Russia 1986 — 1986
MS, Chemical Technology
Moscow State University of Food Production (MGUPP) 1978 — 1983
Jhumki Sen's CSSC Experience January 2004 - September 2004
Job Associate Director, BristolMyers Squibb
Industry Pharmaceuticals
Experience
Bristol-Myers Squibb September 2004 - Present
CSSC January 2004 - September 2004
DataCeutics January 2003 - January 2004
Skills
Validation, Computer System..., 21 CFR Part 11, FDA, GxP, Quality Assurance, Cross-functional Team..., SDLC, Bio Pharmaceutical, Change Control, Regulatory Affairs, Regulatory Submissions, GAMP, Quality System, CAPA, Mobile technology, V&V, Biotechnology, Software Documentation, Clinical Trials, Lifesciences, GCP, Medical Devices, LIMS, Cloud deployments, ITIL, Inspections and Audits, Agile & Waterfall..., Healthcare, Pharmaceutical Industry, SOP, GMP, GLP, Process Improvement, Life Sciences, Pharmaceutics, Vendor Management, CRO, Business Analysis, Regulatory Requirements, Biopharmaceuticals, Business Process..., Document Management, Requirements Analysis, Project Portfolio..., Testing
Education
San Diego State University-California State University 2008 — 2010
MS, Regulatory Affairs
University of San Diego 2007 — 2010
Masters, Regulatory Affairs
Loreto Convent
Presidency College
Masters, English Literature
Bristol-Myers Squibb September 2004 - Present
CSSC January 2004 - September 2004
DataCeutics January 2003 - January 2004
Skills
Validation, Computer System..., 21 CFR Part 11, FDA, GxP, Quality Assurance, Cross-functional Team..., SDLC, Bio Pharmaceutical, Change Control, Regulatory Affairs, Regulatory Submissions, GAMP, Quality System, CAPA, Mobile technology, V&V, Biotechnology, Software Documentation, Clinical Trials, Lifesciences, GCP, Medical Devices, LIMS, Cloud deployments, ITIL, Inspections and Audits, Agile & Waterfall..., Healthcare, Pharmaceutical Industry, SOP, GMP, GLP, Process Improvement, Life Sciences, Pharmaceutics, Vendor Management, CRO, Business Analysis, Regulatory Requirements, Biopharmaceuticals, Business Process..., Document Management, Requirements Analysis, Project Portfolio..., Testing
Education
San Diego State University-California State University 2008 — 2010
MS, Regulatory Affairs
University of San Diego 2007 — 2010
Masters, Regulatory Affairs
Loreto Convent
Presidency College
Masters, English Literature
Gregory Peggott's CSSC Experience September 2003 - June 2008
Job Manager at HighPoint Solutions
Industry Pharmaceuticals
Experience
HighPoint Solutions June 2008 - Present
CSSC September 2003 - June 2008
Education
City University of New York City College 1994 — 2000
BE, Electrical Engineering
HighPoint Solutions June 2008 - Present
CSSC September 2003 - June 2008
Education
City University of New York City College 1994 — 2000
BE, Electrical Engineering
Loriann Russo's CSSC Experience 2002 - 2004
Job Sr. Tech Analyst at Pfizer
Industry Pharmaceuticals
Experience
Pfizer December 2004 - Present
CSSC 2002 - 2004
Education
New York Medical College 1996 — 1999
MS, pharmacology
Hofstra University 1990 — 1994
BS, Biochemistry
Pfizer December 2004 - Present
CSSC 2002 - 2004
Education
New York Medical College 1996 — 1999
MS, pharmacology
Hofstra University 1990 — 1994
BS, Biochemistry
Angie Brock's CSSC Experience 2000 - May 2001
Job Associate Director, Compliance
Industry Pharmaceuticals
Experience
Recro Pharma, Inc. July 2015 - Present
Ethicon February 2013 - July 2015
Alkermes September 2011 - March 2013
Elan May 2001 - September 2011
CSSC 2000 - May 2001
Ethicon 1991 - 1999
Savannah River Site May 1990 - August 1991
Skills
V&V, Validation, CAPA, FDA, Computer System..., Lean Manufacturing, Manufacturing, GxP, Change Control, GMP, 21 CFR Part 11, Aseptic Processing, Sop, Cleaning Validation, Quality System, Biopharmaceuticals, GLP, SOP
Education
Clemson University 1985 — 1990
BS, Chemical Engineering
Recro Pharma, Inc. July 2015 - Present
Ethicon February 2013 - July 2015
Alkermes September 2011 - March 2013
Elan May 2001 - September 2011
CSSC 2000 - May 2001
Ethicon 1991 - 1999
Savannah River Site May 1990 - August 1991
Skills
V&V, Validation, CAPA, FDA, Computer System..., Lean Manufacturing, Manufacturing, GxP, Change Control, GMP, 21 CFR Part 11, Aseptic Processing, Sop, Cleaning Validation, Quality System, Biopharmaceuticals, GLP, SOP
Education
Clemson University 1985 — 1990
BS, Chemical Engineering
Andreas Nshala's CSSC Experience October 2007 - September 2008
Job Student at Dartmouth College
Industry Medical Practice
Experience
Christian Social Services Commission 2007 - Present
CSSC October 2007 - September 2008
Bugando Medical Center September 2006 - June 2007
Family Care International January 2006 - May 2006
Education
Dartmouth College 2009 — 2010
MPH, Public Health
University of Dar es Salaam 2000 — 2005
MD, Medicine
Dartmouth College
The Dartmouth Institute for Health Policy and Clinical Practice
Master of Public Health Degree, MPH
Christian Social Services Commission 2007 - Present
CSSC October 2007 - September 2008
Bugando Medical Center September 2006 - June 2007
Family Care International January 2006 - May 2006
Education
Dartmouth College 2009 — 2010
MPH, Public Health
University of Dar es Salaam 2000 — 2005
MD, Medicine
Dartmouth College
The Dartmouth Institute for Health Policy and Clinical Practice
Master of Public Health Degree, MPH
J. D. Raifsnider's CSSC Experience 1997 - Present
Job Reporter / Photographer
Industry Management Consulting
Experience
CSSC 1997 - Present
Education
University of Maryland University College
Economics
MiraCosta College
Real Estate
CSSC 1997 - Present
Education
University of Maryland University College
Economics
MiraCosta College
Real Estate