Resumes
Resumes
Regulatory Intelligence Manager
View pageLocation:
Madison, WI
Industry:
Medical Devices
Work:
Mentor Biologics (J&J) since Nov 2006
Validation/QA Analyst II
Validation/QA Analyst II
Education:
University of Maryland University College
MS, Biotechnology University of Maryland University College
MBA, Business
MS, Biotechnology University of Maryland University College
MBA, Business
Skills:
Capa
Quality System
Fda
Iso 13485
Validation
Change Control
21 Cfr Part 11
V&V
Gmp
Medical Devices
Fda Gmp
Iso 14971
Sop
Quality Assurance
Quality Auditing
21 Cfr
Supplier Quality
Design Control
Gxp
Risk Management
Cgmp Manufacturing
Personnel Management
Computer System Validation
Aseptic Processing
Cleaning Validation
Iso 9000
Deviations
Regulatory Audits
21 Cfr Part 820
Iso 17025
Iso 9001
Internal Audits
Budget Process
Lims
Standard Operating Procedure
U.s. Food and Drug Administration
Quality System
Fda
Iso 13485
Validation
Change Control
21 Cfr Part 11
V&V
Gmp
Medical Devices
Fda Gmp
Iso 14971
Sop
Quality Assurance
Quality Auditing
21 Cfr
Supplier Quality
Design Control
Gxp
Risk Management
Cgmp Manufacturing
Personnel Management
Computer System Validation
Aseptic Processing
Cleaning Validation
Iso 9000
Deviations
Regulatory Audits
21 Cfr Part 820
Iso 17025
Iso 9001
Internal Audits
Budget Process
Lims
Standard Operating Procedure
U.s. Food and Drug Administration
Certifications:
Cmq/Oe, Certified Manager of Quality/Organizational Excellence
Cqa, Certified Quality Auditor
Cqa, Certified Quality Auditor