Associate Director QA Process Development and Validation @ (September 2019 - August 2020)
Sr. Manager QA Validation @ (April 2018 - September 2019)
Principal Validation Engineer @ (October 2015 - April 2018)
Sr. Process Validation Engineer @ (August 2014 - October 2015)
Sr Process Validation Engineer @ (July 2013 - August 2014)
Sr Validation Engineer @ Hyde Engineering + Consulting (HTS) - Novartis (March 2012 - July 2013)
Validation Engineer @ (July 2011 - February 2012)
Validation Engineer @ (January 2008 - July 2011)
Validation Specialist @ (January 2006 - December 2007)
Process Scientist @ (June 2004 - December 2005)
Pedro A Rivera Education
University of Puerto Rico-Mayaguez
Bachelor's degree (Biotechnology / Chem E)
University of Puerto Rico-Mayaguez
Pedro A Rivera Skills
21 CFR Part 11
Aseptic Processing
Biopharmaceuticals
Biotechnology
CAPA
CMC
Cell Culture
Cell Therapy
Change Control
Change Management
Chromatography
Cleaning Validation
Computer System Validation
Corrective and Preventive Action (CAPA)
Deviation Management
Equipment Qualification
FDA
Fermentation
GAMP
GLP
GMP
Good Manufacturing Practice (GMP)
GxP
LIMS
Lyophilization
Manufacturing
Medical Devices
Pharmaceutical Industry
Purification
Quality Assurance
Quality Control
Quality Management
Quality System
Regulatory Submissions
Risk Assessment
Root Cause Analysis
SOP
Standard Operating Procedure (SOP)
Supplier Evaluation
Supplier Quality
Technical Reports
Technology Transfer
TrackWise
U.S. Food and Drug Administration (FDA)
U.S. Title 21 CFR Part 11 Regulation
V&V
Validation
Verification and Validation (V&V)
Standard Operating Procedure Sop
Engineering
Customer Service
Strategy
Data Validation
Process Validation
Verification and Validation V&V
Molecular Biology
u.s. Food and Drug Administration Fda
Computer System
SQL
Process Improvement
Testing
Corrective and Preventive Action Capa
Blood
Leadership
Strategic Planning
Research
Management
Project Management
Software Development
Good Manufacturing Practice Gmp
Standard Operating Procedure
u.s. Food and Drug Administration
Corrective and Preventive Action
Verification and Validation
Good Manufacturing Practice
Pedro A Rivera Summary
Pedro A Rivera, based in California, United States, is currently a Sr Director Quality Assurance - Global Product Distribution and Affiliates (GPD and A) at Gilead Sciences. Pedro A Rivera brings experience from previous roles at Ultragenyx. Pedro A Rivera holds a Bachelor's degree in Biotechnology / Chem E @ University of Puerto Rico-Mayaguez. With a robust skill set that includes 21 CFR Part 11, Aseptic Processing, Biopharmaceuticals, Biotechnology, CAPA and more. Pedro A Rivera has 3 emails and 3 mobile phone numbers on RocketReach.
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