2007 -2011 Director, QA and Regulatory Compliance @
1990 -2007 Director, Global Quality @
1986 -1989 QA Specialist @
1983 -1986 QA Tech. @ Analytab Products, Inc.
Paula Osorio Education
Adelphi University
M.B.A. (Business, International Business)
1983-1986
University of Wisconsin-La Crosse
B.S. (Microbiology)
1978-1982
Paula Osorio Skills
Quality Assurance
Microbiology
CAPA
FDA
ISO 13485
Medical Devices
Design Control
GMP
Regulatory Affairs
Quality System
Validation
V&V
Quality Auditing
Sterilization
CE marking
Quality Control
ISO
Sop
Change Control
21 CFR Part 11
ISO 14971
FDA GMP
Computer System Validation
GLP
21 CFR
Aseptic Processing
Regulatory Submissions
GxP
Regulatory Requirements
Trackwise
Cleaning Validation
PMA
Medical Device Directive
Biotechnology
GCP
Commercialization
Technology Transfer
Biopharmaceuticals
R&D
Lifesciences
Pharmaceutical Industry
Complaint Management
Quality Management
Life Sciences
Verification and Validation (V&V)
ISO Standards
U.S. Food and Drug Administration (FDA)
Verification And Validation V&V
Regulatory
Compliance
U.S. Food And Drug Administration Fda
u.s. Food and Drug Administration
Verification and Validation
Paula Osorio Summary
Paula Osorio, based in Loveland, OH, US, is currently a Senior Alpine Ski Patroller at Perfect North Slopes. Paula Osorio brings experience from previous roles at Johnson & Johnson, Integra Life Sciences, Integra LifeSciences and Zimmer Biomet. Paula Osorio holds a 1983 - 1986 M.B.A. in Business, International Business @ Adelphi University. With a robust skill set that includes Quality Assurance, Microbiology, CAPA, FDA, ISO 13485 and more. Paula Osorio has 2 emails and 1 mobile phone numbers on RocketReach.
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