Quality Compliance Partners
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Quality Compliance Partners Employees
Employee
Years
Job
Industry
Paul Eichholz, ASQ - CMQ/OE Paul Eichholz, ASQ - CMQ/OE's Quality Compliance Partners Experience July 2010 - April 2011
Job Director, QRA Management
Industry Pharmaceuticals
Experience
The Harvard Drug Group September 2014 - Present
The Harvard Drug Group October 2012 - September 2014
Legacy Pharmaceutical Packaging April 2011 - October 2012
Quality Compliance Partners July 2010 - April 2011
Qualicaps, Inc April 2009 - July 2010
KV Pharmaceutical September 2006 - April 2009
Solvay Pharmaceuticals February 2004 - September 2006
Akorn Inc. Pharmaceuticals May 2003 - February 2004
Wyeth BioPharma July 2001 - May 2003
General Physics Corporation May 2000 - July 2001
Skills
Quality Assurance, GMP, Auditing, Supplier Quality, Quality Systems, FDA, Contract Manufacturing, Instructional Design, E-learning, Quality Auditing, CAPA, Validation, Regulatory Affairs, Change Control, Root Cause Analysis, Document Management, Investigations, Pharmaceuticals, cGMP, Quality Management, Compliance, SOP, Process Improvement, Continuous Improvement, Process Validation, Change Management, Documentation, Problem Solving, 21 CFR Part 11, Technical Writing, Operational Excellence, Coaching, Software Documentation, Sop, Quality System, Pharmaceutical Industry, E-Learning, Six Sigma, Lean Manufacturing, V&V, Cross-functional Team..., Manufacturing, Training, Quality Control, GLP, Cleaning Validation, Computer System..., Pharmaceutics, Trackwise, ISO 13485
Education
Seton Hall University School of Law 2014 — 2016
Master’s Degree, Pharmaceutical and Medical Device Compliance Law, Currently 3.86
University of Phoenix 2001 — 2003
B.S., Business Management, Graduated with Honors
The Harvard Drug Group September 2014 - Present
The Harvard Drug Group October 2012 - September 2014
Legacy Pharmaceutical Packaging April 2011 - October 2012
Quality Compliance Partners July 2010 - April 2011
Qualicaps, Inc April 2009 - July 2010
KV Pharmaceutical September 2006 - April 2009
Solvay Pharmaceuticals February 2004 - September 2006
Akorn Inc. Pharmaceuticals May 2003 - February 2004
Wyeth BioPharma July 2001 - May 2003
General Physics Corporation May 2000 - July 2001
Skills
Quality Assurance, GMP, Auditing, Supplier Quality, Quality Systems, FDA, Contract Manufacturing, Instructional Design, E-learning, Quality Auditing, CAPA, Validation, Regulatory Affairs, Change Control, Root Cause Analysis, Document Management, Investigations, Pharmaceuticals, cGMP, Quality Management, Compliance, SOP, Process Improvement, Continuous Improvement, Process Validation, Change Management, Documentation, Problem Solving, 21 CFR Part 11, Technical Writing, Operational Excellence, Coaching, Software Documentation, Sop, Quality System, Pharmaceutical Industry, E-Learning, Six Sigma, Lean Manufacturing, V&V, Cross-functional Team..., Manufacturing, Training, Quality Control, GLP, Cleaning Validation, Computer System..., Pharmaceutics, Trackwise, ISO 13485
Education
Seton Hall University School of Law 2014 — 2016
Master’s Degree, Pharmaceutical and Medical Device Compliance Law, Currently 3.86
University of Phoenix 2001 — 2003
B.S., Business Management, Graduated with Honors
Davide Tenaglia Davide Tenaglia's Quality Compliance Partners Experience November 2013 - June 2014
Job Professional Services Consultant at MasterControl
Industry Computer Software
Experience
MasterControl June 2015 - Present
The Ashwood Group, LLC November 2013 - Present
Quality Compliance Partners November 2013 - June 2014
Boehringer Ingelheim August 2012 - October 2013
Amgen 2006 - August 2012
Sandoz February 2004 - December 2006
Eastman Kodak March 2000 - January 2004
Skills
Change Control, Validation, Sop, GMP, Quality System, Quality Assurance, Pharmaceutical Industry, V&V, 21 CFR Part 11, CAPA, Biotechnology, LIMS, Root Cause Analysis, FDA, Trackwise, Manufacturing, Regulatory Affairs, Biopharmaceuticals, Aseptic Processing, Cleaning Validation, Technology Transfer, Chromatography, Regulatory Requirements, GxP, Laboratory, SOP, TrackWise
Education
California State University-Long Beach 1990 — 1996
M.S., Chemistry
University of Southern California 1985 — 1990
B.S., Electrical Engineering
MasterControl June 2015 - Present
The Ashwood Group, LLC November 2013 - Present
Quality Compliance Partners November 2013 - June 2014
Boehringer Ingelheim August 2012 - October 2013
Amgen 2006 - August 2012
Sandoz February 2004 - December 2006
Eastman Kodak March 2000 - January 2004
Skills
Change Control, Validation, Sop, GMP, Quality System, Quality Assurance, Pharmaceutical Industry, V&V, 21 CFR Part 11, CAPA, Biotechnology, LIMS, Root Cause Analysis, FDA, Trackwise, Manufacturing, Regulatory Affairs, Biopharmaceuticals, Aseptic Processing, Cleaning Validation, Technology Transfer, Chromatography, Regulatory Requirements, GxP, Laboratory, SOP, TrackWise
Education
California State University-Long Beach 1990 — 1996
M.S., Chemistry
University of Southern California 1985 — 1990
B.S., Electrical Engineering
Allen Kuusela Allen Kuusela's Quality Compliance Partners Experience September 2013 - Present
Job Quality Compliance Consultant at Quality Compliance Partners
Industry Pharmaceuticals
Experience
Quality Compliance Partners September 2013 - Present
Validation/Regulatory Professional 2007 - Present
PAREXEL September 2013 - May 2015
Sanofi Pasteur Ltd. September 2013 - May 2015
NNE Pharmaplan 2015 - 2015
NNE Pharmaplan 2015 - 2015
NNE Pharmaplan 2015 - 2015
NNE Pharmaplan 2015 - 2015
Regeneron June 2011 - September 2013
Bristol-Myers Squibb October 2009 - April 2010
Skills
Validation, GMP, Change Control, V&V, Sop, Computer System..., Cleaning Validation, Analytical Chemistry, FDA, Quality Assurance, Aseptic Processing, 21 CFR Part 11, GAMP, Pharmaceutical Industry, Medical Devices, Biotechnology, Commissioning, Testing, GxP, Technology Transfer, Biopharmaceuticals, Quality Auditing, Quality System, CAPA, GLP, Microbiology, Software Documentation, Sterilization, CIP, Regulatory Affairs, Quality Management, Change Management, Manufacturing, Technical Writing, Lifesciences, Management, Regulatory Requirements, Risk Assessment, Document Management, Process Simulation, Start-ups, Business Development, Auditing, Packaging, Quality Systems, Life Sciences, Consent Decree..., LIMS, SOP
Education
Keene State College 1980 — 1984
BS, Bio-Chem
Quality Compliance Partners September 2013 - Present
Validation/Regulatory Professional 2007 - Present
PAREXEL September 2013 - May 2015
Sanofi Pasteur Ltd. September 2013 - May 2015
NNE Pharmaplan 2015 - 2015
NNE Pharmaplan 2015 - 2015
NNE Pharmaplan 2015 - 2015
NNE Pharmaplan 2015 - 2015
Regeneron June 2011 - September 2013
Bristol-Myers Squibb October 2009 - April 2010
Skills
Validation, GMP, Change Control, V&V, Sop, Computer System..., Cleaning Validation, Analytical Chemistry, FDA, Quality Assurance, Aseptic Processing, 21 CFR Part 11, GAMP, Pharmaceutical Industry, Medical Devices, Biotechnology, Commissioning, Testing, GxP, Technology Transfer, Biopharmaceuticals, Quality Auditing, Quality System, CAPA, GLP, Microbiology, Software Documentation, Sterilization, CIP, Regulatory Affairs, Quality Management, Change Management, Manufacturing, Technical Writing, Lifesciences, Management, Regulatory Requirements, Risk Assessment, Document Management, Process Simulation, Start-ups, Business Development, Auditing, Packaging, Quality Systems, Life Sciences, Consent Decree..., LIMS, SOP
Education
Keene State College 1980 — 1984
BS, Bio-Chem
Al Holstein's Quality Compliance Partners Experience November 2010 - April 2011
Job Contractor at Gilead Sciences
Industry Pharmaceuticals
Experience
Al Holstein Consulting March 2015 - Present
Gilead Sciences October 2013 - December 2014
Quality Compliance Partners November 2010 - April 2011
Roche Palo Alto 2004 - 2010
Roche Pharmaceuticals 1995 - 2004
Syntex 1972 - 1995
Skills
GMP, Sop, Quality Assurance, FDA, Biotechnology, Quality Auditing, Drug Discovery, Organic Chemistry, Pharmaceutical Industry, Validation, R&D, Regulatory Submissions, GLP, GxP, 21 CFR Part 11, CAPA, Change Control, Computer System..., LIMS, V&V
Education
Fort Hays State University 1963 — 1970
BS MS
Al Holstein Consulting March 2015 - Present
Gilead Sciences October 2013 - December 2014
Quality Compliance Partners November 2010 - April 2011
Roche Palo Alto 2004 - 2010
Roche Pharmaceuticals 1995 - 2004
Syntex 1972 - 1995
Skills
GMP, Sop, Quality Assurance, FDA, Biotechnology, Quality Auditing, Drug Discovery, Organic Chemistry, Pharmaceutical Industry, Validation, R&D, Regulatory Submissions, GLP, GxP, 21 CFR Part 11, CAPA, Change Control, Computer System..., LIMS, V&V
Education
Fort Hays State University 1963 — 1970
BS MS
Evan Mignogna's Quality Compliance Partners Experience March 2013 - March 2014
Job Available Recruiter
Industry Human Resources
Experience
Recruiting Consultant January 2015 - Present
USDM Life Sciences April 2014 - November 2014
Quality Compliance Partners March 2013 - March 2014
Mindlance May 2012 - 2013
Ostendo Technologies February 2012 - April 2012
Next Autoworks Company April 2008 - December 2011
Kaizen Staffing / Payrolling.com January 2008 - April 2008
QINETIQ North America (Formerly Apogen Technologies) November 2007 - January 2008
Manpower Professional July 2006 - October 2007
Cardinal Health October 2005 - February 2006
Skills
Talent Management, Telecommunications, Automotive, Finance, Software, Pharmaceutics, Biotechnology, Talent Acquisition, Defense, Technical Recruiting, Applicant Tracking..., Recruiting, Sourcing, Human Resources, Executive Search, Screening, Internet Recruiting, Contract Recruitment, College Recruiting, Staffing Services, Start-ups, Process Improvement, Strategic Sourcing, Training, Employee Relations, Employer Branding, Benefits Negotiation, Employee Engagement, Hiring, Leadership, Strategy, Vendor Management, Screening Resumes, Manufacturing, Team Leadership, Interviews, Temporary Staffing, Temporary Placement, Management, Staff Augmentation, Networking, Permanent Placement, HR Consulting, Resume Writing, Onboarding, Personnel Management, Payroll, Workforce Planning, Team Building, HRIS
Education
University of New Hampshire - Whittemore School of Business and Economics 1995 — 1999
B.S., Business Administration
Gilford High School
Recruiting Consultant January 2015 - Present
USDM Life Sciences April 2014 - November 2014
Quality Compliance Partners March 2013 - March 2014
Mindlance May 2012 - 2013
Ostendo Technologies February 2012 - April 2012
Next Autoworks Company April 2008 - December 2011
Kaizen Staffing / Payrolling.com January 2008 - April 2008
QINETIQ North America (Formerly Apogen Technologies) November 2007 - January 2008
Manpower Professional July 2006 - October 2007
Cardinal Health October 2005 - February 2006
Skills
Talent Management, Telecommunications, Automotive, Finance, Software, Pharmaceutics, Biotechnology, Talent Acquisition, Defense, Technical Recruiting, Applicant Tracking..., Recruiting, Sourcing, Human Resources, Executive Search, Screening, Internet Recruiting, Contract Recruitment, College Recruiting, Staffing Services, Start-ups, Process Improvement, Strategic Sourcing, Training, Employee Relations, Employer Branding, Benefits Negotiation, Employee Engagement, Hiring, Leadership, Strategy, Vendor Management, Screening Resumes, Manufacturing, Team Leadership, Interviews, Temporary Staffing, Temporary Placement, Management, Staff Augmentation, Networking, Permanent Placement, HR Consulting, Resume Writing, Onboarding, Personnel Management, Payroll, Workforce Planning, Team Building, HRIS
Education
University of New Hampshire - Whittemore School of Business and Economics 1995 — 1999
B.S., Business Administration
Gilford High School
Chris Steinberg's Quality Compliance Partners Experience September 2011 - March 2012
Job
Industry Pharmaceuticals
Experience
Pharmaceutical Validation Solutions, Inc. July 2014 - December 2014
ProPharma Group December 2013 - April 2014
Integrated Project Services October 2012 - September 2013
Integrated Project Services April 2012 - September 2012
Quality Compliance Partners September 2011 - March 2012
Integrated Project Services April 2011 - September 2011
RCM Technologies, Inc November 2010 - February 2011
Quality Compliance Partners June 2009 - July 2010
Integrated Project Services January 2003 - September 2008
TechSource, Inc September 2003 - January 2004
Skills
Validation, Computer System..., Commissioning, 21 CFR Part 11, Validation Master Plans, Change Control, GMP, V&V, GxP, Sop, FDA, GAMP, CAPA, Quality System, Pharmaceutical Industry, Biopharmaceuticals, GLP, Aseptic Processing, Technology Transfer, Software Documentation, Quality Auditing, Quality Control, Testing, Lifesciences, R&D, LIMS, Quality Assurance, SOP
Education
Temple University
Degree: Bachelor Degree
Williamsport Area Community College
Degree: Associate of Applied
Pharmaceutical Validation Solutions, Inc. July 2014 - December 2014
ProPharma Group December 2013 - April 2014
Integrated Project Services October 2012 - September 2013
Integrated Project Services April 2012 - September 2012
Quality Compliance Partners September 2011 - March 2012
Integrated Project Services April 2011 - September 2011
RCM Technologies, Inc November 2010 - February 2011
Quality Compliance Partners June 2009 - July 2010
Integrated Project Services January 2003 - September 2008
TechSource, Inc September 2003 - January 2004
Skills
Validation, Computer System..., Commissioning, 21 CFR Part 11, Validation Master Plans, Change Control, GMP, V&V, GxP, Sop, FDA, GAMP, CAPA, Quality System, Pharmaceutical Industry, Biopharmaceuticals, GLP, Aseptic Processing, Technology Transfer, Software Documentation, Quality Auditing, Quality Control, Testing, Lifesciences, R&D, LIMS, Quality Assurance, SOP
Education
Temple University
Degree: Bachelor Degree
Williamsport Area Community College
Degree: Associate of Applied
Osman Kafrawy, CQA's Quality Compliance Partners Experience January 2014 - March 2015
Job Quality Assurance Consultant
Industry Pharmaceuticals
Experience
Quality Compliance Partners January 2014 - March 2015
Quality Compliance Partners May 2013 - January 2014
Quality Compliance Partners March 2010 - May 2013
Quality Compliance Partners September 2009 - March 2010
Roche Diagnostics September 2006 - September 2009
Mead Johnson Nutritionals January 2005 - September 2006
American Pharmaceutical Partners 2003 - 2005
Abbott Laboratories 2000 - 2003
Skills
Cleaning Validation, Validation, Computer System..., Medical Devices, cGMP, GMP, Change Control, 21 CFR Part 11, CAPA, GxP, Regulatory Submissions, Analytical Chemistry, Quality Assurance, Chemistry, Chromatography, Automation, Quality Control, LIMS, FDA, V&V, Aseptic Processing, GAMP, Quality Auditing, Quality System, GLP, Technology Transfer, Biopharmaceuticals, Regulatory Affairs, Pharmaceutics, Pharmaceutical Industry, ISO 13485, Sop, Design Control, Regulatory Requirements, GCP, Testing, Biotechnology
Education
Purdue University 1994 — 1998
BS, Biology
Quality Compliance Partners January 2014 - March 2015
Quality Compliance Partners May 2013 - January 2014
Quality Compliance Partners March 2010 - May 2013
Quality Compliance Partners September 2009 - March 2010
Roche Diagnostics September 2006 - September 2009
Mead Johnson Nutritionals January 2005 - September 2006
American Pharmaceutical Partners 2003 - 2005
Abbott Laboratories 2000 - 2003
Skills
Cleaning Validation, Validation, Computer System..., Medical Devices, cGMP, GMP, Change Control, 21 CFR Part 11, CAPA, GxP, Regulatory Submissions, Analytical Chemistry, Quality Assurance, Chemistry, Chromatography, Automation, Quality Control, LIMS, FDA, V&V, Aseptic Processing, GAMP, Quality Auditing, Quality System, GLP, Technology Transfer, Biopharmaceuticals, Regulatory Affairs, Pharmaceutics, Pharmaceutical Industry, ISO 13485, Sop, Design Control, Regulatory Requirements, GCP, Testing, Biotechnology
Education
Purdue University 1994 — 1998
BS, Biology
Jeff Barbour's Quality Compliance Partners Experience May 2011 - July 2011
Job Validation Consultant at Biomedical Systems
Industry Pharmaceuticals
Experience
Pfizer March 2014 - Present
Biomedical Systems April 2012 - March 2014
Enterprise System Partners July 2011 - March 2012
Quality Compliance Partners May 2011 - July 2011
CGMP Consulting November 2010 - January 2011
Enterprise System Partners Limited September 2009 - October 2010
Barry-Wehmiller Design Group July 2009 - October 2009
KV Pharmaceutical Company July 2003 - February 2009
Bayer Pharmaceuticals January 2001 - June 2003
Bayer Pharmaceuticals June 1999 - January 2001
Skills
LIMS, Quality System, Project Management, ERP, Clinical Research, Pharmacovigilance, SCADA, PLC, DCS, Infrastructure, Computer System..., Validation, 21 CFR Part 11, Building Management..., Change Control, FDA, Sop, GMP, CAPA, Pharmaceutical Industry
Education
University of Phoenix 2004 — 2009
BSIT, Information Technology
University of Phoenix 2001 — 2003
AAGS, General Studies
North Carolina State University 1985 — 1988
Pfizer March 2014 - Present
Biomedical Systems April 2012 - March 2014
Enterprise System Partners July 2011 - March 2012
Quality Compliance Partners May 2011 - July 2011
CGMP Consulting November 2010 - January 2011
Enterprise System Partners Limited September 2009 - October 2010
Barry-Wehmiller Design Group July 2009 - October 2009
KV Pharmaceutical Company July 2003 - February 2009
Bayer Pharmaceuticals January 2001 - June 2003
Bayer Pharmaceuticals June 1999 - January 2001
Skills
LIMS, Quality System, Project Management, ERP, Clinical Research, Pharmacovigilance, SCADA, PLC, DCS, Infrastructure, Computer System..., Validation, 21 CFR Part 11, Building Management..., Change Control, FDA, Sop, GMP, CAPA, Pharmaceutical Industry
Education
University of Phoenix 2004 — 2009
BSIT, Information Technology
University of Phoenix 2001 — 2003
AAGS, General Studies
North Carolina State University 1985 — 1988
David Velez's Quality Compliance Partners Experience June 2015 - August 2015
Job Sr. Life Sciences Professional
Industry Pharmaceuticals
Experience
Quality Compliance Partners June 2015 - August 2015
Malcom Associates June 2014 - November 2014
Oxford Global Resources August 2013 - May 2014
Malcom Associates June 2009 - February 2013
ALKU 2013 - 2013
Strategic Technologies Inc 2005 - May 2009
P3 Laboratories 2006 - 2006
Brighton Associates LLC 2003 - 2005
Validation and Integration Providers 2002 - 2003
Decision Management International 1999 - 2002
Skills
Compliance, Biotechnology, Manufacturing, Quality Assurance, FDA, Pharmaceuticals, Medical Devices, Life Sciences, Documentation, Regulatory Affairs, GMP, Quality Systems, SOP, Change Management, Process Validation, Pharmaceutical Industry, Cross-functional Team..., Lifesciences, Program Management, Software Documentation, Continuous Improvement, CAPA, Pharmaceutics, R&D, Change Control, Sop, V&V, Quality Management, Quality System, Validation, Technology Transfer, Auditing, 21 CFR Part 11, GxP, Testing, GAMP, Quality Auditing, Process Simulation, Document Management, Biopharmaceuticals, LIMS, Regulatory Requirements, Quality Control, Microbiology, GLP
Education
University of Puerto Rico, Mayaguez campus 1985 — 1990
Bachelor of Applied Science (B.A.Sc.), Industrial Microbiology, Magna Cum Laude
University of Puerto Rico-Mayaguez 1985 — 1990
Bachelor of Applied Science (B.A.Sc.), Industrial Microbiology
Quality Compliance Partners June 2015 - August 2015
Malcom Associates June 2014 - November 2014
Oxford Global Resources August 2013 - May 2014
Malcom Associates June 2009 - February 2013
ALKU 2013 - 2013
Strategic Technologies Inc 2005 - May 2009
P3 Laboratories 2006 - 2006
Brighton Associates LLC 2003 - 2005
Validation and Integration Providers 2002 - 2003
Decision Management International 1999 - 2002
Skills
Compliance, Biotechnology, Manufacturing, Quality Assurance, FDA, Pharmaceuticals, Medical Devices, Life Sciences, Documentation, Regulatory Affairs, GMP, Quality Systems, SOP, Change Management, Process Validation, Pharmaceutical Industry, Cross-functional Team..., Lifesciences, Program Management, Software Documentation, Continuous Improvement, CAPA, Pharmaceutics, R&D, Change Control, Sop, V&V, Quality Management, Quality System, Validation, Technology Transfer, Auditing, 21 CFR Part 11, GxP, Testing, GAMP, Quality Auditing, Process Simulation, Document Management, Biopharmaceuticals, LIMS, Regulatory Requirements, Quality Control, Microbiology, GLP
Education
University of Puerto Rico, Mayaguez campus 1985 — 1990
Bachelor of Applied Science (B.A.Sc.), Industrial Microbiology, Magna Cum Laude
University of Puerto Rico-Mayaguez 1985 — 1990
Bachelor of Applied Science (B.A.Sc.), Industrial Microbiology
Alexis Najarro's Quality Compliance Partners Experience May 2009 - Present
Job Validation Compliance Consultant at Quality Compliance Partners
Industry Biotechnology
Experience
Quality Compliance Partners May 2009 - Present
Pacira Pharmaceuticals December 2006 - December 2008
Skills
Validation, V&V, Sop, Software Documentation, Manufacturing, Aseptic Processing, GMP, Cleaning Validation, HPLC, 21 CFR Part 11, Lifesciences
Education
Monterey Peninsula College 2000 — 2002
Associate, Science
California State University San Marcos
Bachelor's, Biology
Quality Compliance Partners May 2009 - Present
Pacira Pharmaceuticals December 2006 - December 2008
Skills
Validation, V&V, Sop, Software Documentation, Manufacturing, Aseptic Processing, GMP, Cleaning Validation, HPLC, 21 CFR Part 11, Lifesciences
Education
Monterey Peninsula College 2000 — 2002
Associate, Science
California State University San Marcos
Bachelor's, Biology
Darryl Stumpf's Quality Compliance Partners Experience July 2008 - August 2008
Job validation engineer at Oxford Global Resources
Industry Pharmaceuticals
Experience
Oxford Global Resources May 2011 - December 2013
Randstad June 2009 - March 2011
Quality Compliance Partners July 2008 - August 2008
Aerotek April 2007 - February 2008
The Experts, Inc. August 2006 - January 2007
Arbour Group LLC January 2005 - February 2006
Washington Group Inc. / Raytheon E&C 1999 - 2004
Skills
CAPA, V&V, Validation, Computer System..., 21 CFR Part 11, FDA, ISO 13485, GxP, Cleaning Validation, Change Control, Quality System, GMP, Aseptic Processing, Testing, Software Documentation, SOP, GAMP
Education
Southern Illinois University, Edwardsville 1995 — 1997
Bachelor of Science (B.S.), Mechanical Engineering
Lewis and Clark Community College 1993 — 1995
Associate of Science (AS), Pre-Engineering
Oxford Global Resources May 2011 - December 2013
Randstad June 2009 - March 2011
Quality Compliance Partners July 2008 - August 2008
Aerotek April 2007 - February 2008
The Experts, Inc. August 2006 - January 2007
Arbour Group LLC January 2005 - February 2006
Washington Group Inc. / Raytheon E&C 1999 - 2004
Skills
CAPA, V&V, Validation, Computer System..., 21 CFR Part 11, FDA, ISO 13485, GxP, Cleaning Validation, Change Control, Quality System, GMP, Aseptic Processing, Testing, Software Documentation, SOP, GAMP
Education
Southern Illinois University, Edwardsville 1995 — 1997
Bachelor of Science (B.S.), Mechanical Engineering
Lewis and Clark Community College 1993 — 1995
Associate of Science (AS), Pre-Engineering
Pamela Sklanka's Quality Compliance Partners Experience June 2007 - September 2007
Job Regional Director Consulting ServicesQuality Compliance Development
Industry Biotechnology
Experience
Life Technologies August 2009 - February 2012
CV Partners / XenoPort October 2008 - July 2009
Atos Origin August 2007 - July 2008
Scientific Careers January 2007 - July 2008
Quality Compliance Partners June 2007 - September 2007
Averent July 2006 - September 2006
Genentech August 2004 - July 2006
IT&E Consulting May 2004 - August 2004
Quintiles Consulting June 2002 - April 2004
Atrix Laboratories February 2001 - October 2001
Skills
Validation, 21 CFR Part 11, CAPA, Change Control, Computer System..., Cross-functional Team..., FDA, Medical Devices, Process Improvement, Quality Assurance, Quality Control, Quality System, Software Documentation, Sop, Testing, Quality Management, ISO, Biotechnology, Life Sciences, Pharmaceutical Industry, GMP, Management, Quality Auditing
Education
Metro State College 1984 — 1988
BA, Athletic Training (Sports Medicine)
Fort Lewis College 1982 — 1983
Business Management
Aims Community College 1982 — 1982
Chemical Testing Technology
Life Technologies August 2009 - February 2012
CV Partners / XenoPort October 2008 - July 2009
Atos Origin August 2007 - July 2008
Scientific Careers January 2007 - July 2008
Quality Compliance Partners June 2007 - September 2007
Averent July 2006 - September 2006
Genentech August 2004 - July 2006
IT&E Consulting May 2004 - August 2004
Quintiles Consulting June 2002 - April 2004
Atrix Laboratories February 2001 - October 2001
Skills
Validation, 21 CFR Part 11, CAPA, Change Control, Computer System..., Cross-functional Team..., FDA, Medical Devices, Process Improvement, Quality Assurance, Quality Control, Quality System, Software Documentation, Sop, Testing, Quality Management, ISO, Biotechnology, Life Sciences, Pharmaceutical Industry, GMP, Management, Quality Auditing
Education
Metro State College 1984 — 1988
BA, Athletic Training (Sports Medicine)
Fort Lewis College 1982 — 1983
Business Management
Aims Community College 1982 — 1982
Chemical Testing Technology