James Middlecamp resumes & CV records
Resumes
Quality Systems Manager At Alkermes Pharmaceuticals
Position:
QA Manager - Quality Systems at Alkermes
Location:
Suwanee, Georgia
Industry:
Biotechnology
Work:
Alkermes
- Gainesville, Georgia since Sep 2010
QA Manager - Quality Systems Consultant Feb 2010 - Jan 2011
Validation Engineer - Project manager Novartis Vaccines Division Sep 2003 - Dec 2009
Associate Director, QA Compliance Solvay Pharmaceuticals Jan 2001 - Sep 2003
Sr. IT Analyst
QA Manager - Quality Systems Consultant Feb 2010 - Jan 2011
Validation Engineer - Project manager Novartis Vaccines Division Sep 2003 - Dec 2009
Associate Director, QA Compliance Solvay Pharmaceuticals Jan 2001 - Sep 2003
Sr. IT Analyst
Education:
Houston Baptist University 1997 - 1999
Master of Science, Management Information Systems Southern Illinois University, Carbondale 1987 - 1990
Bachelor of Science, Industrial Engineering
Master of Science, Management Information Systems Southern Illinois University, Carbondale 1987 - 1990
Bachelor of Science, Industrial Engineering
Skills:
Change Control, CQE, Computer System Validation, Validation, 21 CFR Part 11, GAMP, GxP, Quality Systems, Risk Management, CAPA, Medical Devices, Software Validation, SOP, cGMP, Process Validation, Quality Assurance, Quality Auditing, Quality Management, Document Management, Compliance, Biotechnology, SDLC, FMEA, Process Engineering, Continuous Improvement, GMP, Sop, Quality System, V&V
Interests:
Family, Coaching employees, Golf, Sports Cars
Honor & Awards:
Novartis - R&D Executive Award - 2006
Certifications:
Certified Quality Engineer, American Society for Quality
Certified Lean Six Sigma Green Belt, The University of Georgia
Batch Record Review and Investigations, PharmaNet - John Lee
Certified Lean Six Sigma Green Belt, The University of Georgia
Batch Record Review and Investigations, PharmaNet - John Lee