2013 -2017 Manager of QA Documentation and Change Control @
2012 -2013 Project Director of Shilay Associates Inc - cGMP Document Engineering Consultant Company @
2011 -2012 Project Director of Shilay Associates Inc - cGMP Document Engineering Consultant Company @ Shilay Associates Inc
2011 -2011 Change Control Lead for VVM Vaccine areas @
2008 -2011 Senior Documentation Specialist @
2008 -2008 Senior Consultant of Brighton Associates LLC - cGMP Document Engineering Consultant Company @
2006 -2007 Senior Consultant of Brighton Associates LLC - cGMP Document Engineering Consultant Company @
2004 -2006 Chemical Operations Investigations Specialist @
2002 -2004 Quality Assurance Specialist @
2000 -2001 Dental Laboratory Professor @ Instituto de Educación Superior Daniel A. Carrión
1995 -2001 General Dentist @ General Dentist
Rafael A. Cisneros Education
Universidad de San Martín de Porres
Doctor (Dentistry)
1988-1995
Claretiano
Rafael A. Cisneros Skills
Validation
Quality Management
Change Management
Biopharmaceuticals
Data Management
Standard Operating Procedure (SOP)
Quality System
Quality Assurance
Change Control
GMP
CAPA
21 CFR Part 11
FDA
Documentation
Pharmaceutical Industry
Biotechnology
Medical Devices
Process Improvement
Continuous Improvement
Project Management
Training
Microsoft Office
Microsoft Excel
Microsoft Word
PowerPoint
Software Documentation
Strategy
Strategic Planning
U.S. Food and Drug Administration (FDA)
Corrective and Preventive Action (CAPA)
Quality Systems
Quality System Compliance
Quality Systems Design
Document Management
Document control
Healthcare
Marketing
U.S. Food And Drug Administration Fda
Management
Dentistry
Financial Advisory
Supplies
Consulting
Chemical
Strategic Projects
Visions
Revisions
Digital Preservation
Trackwise
SAN
Consent Decree
Particle
APIs
Dispositions
Deviations
Liquids
Batch Processing
SME
Internal and External
Master Control
Third Party
Assessment
Closure
Design
Public Relations
Assurance
Sop
Metrics
Rules
Resolve
Spanish
Auditing
Data Storage
Steroids
Monitors
Labels
Qualification
Specifics
Capas
Foundation
System
Business Services
Cell
English
Project Leadership
Track Wise
Engineering
Reports
Flat Patterning
Solution Implementation
Councils
Consolidation
Revision
Dental Surgery
Piloting
Creams
Assembly
Supply
Streamlining
Quality Control
Trains and Add Rails
Investigation
Analysis
Kepner Tregoe
Written
Business Continuity Planning
Trident
Laboratory
Concepts
Sterilization
Gap Analysis
Yahoo
C
Management System
FIX Protocol
Business Expansion
Training Documentation
Business Alignment
TGA
Active
SIP
Operations
Weight
Aligning
Remediation
Project
Governance
Plants
Facilities Management
Consent
Closures
Paper
Standardization
Covering
Presentations
Batch Records
Ancillary
Responsibility
Packaging
Regulations
Quality Operations
Executions
Root Cause Analysis
History
Forms
Electronics
Regulatory Standards
Alignments
Records Management
Corrective and Preventive Action Capa
San Diego
Compliance
Process Transfers
Addressing
Proposal Writing
Pharmaceutics
Manufacturing
Internal Controls
Decision Making
Vaccines
Problem Solving
Filing
Meetings
Supply Chain
Architecture
Rtf
Coordinate
Gaps
Leadership Experience
u.s. Food and Drug Administration
Corrective and Preventive Action
Rafael A. Cisneros Summary
Rafael A. Cisneros, based in Raleigh, NC, US, is currently a Manager Quality Systems, Training at NeoGenomics Laboratories. Rafael A. Cisneros brings experience from previous roles at TG Therapeutics, Inc., LMN - Pfizer, Organogenesis Inc. (Before Shire Pharmaceutical) and Shire Pharmaceuticals. Rafael A. Cisneros holds a 1988 - 1995 Doctor in Dentistry @ Universidad de San Martín de Porres. With a robust skill set that includes Validation, Quality Management, Change Management, Biopharmaceuticals, Data Management and more. Rafael A. Cisneros has 2 emails and 1 mobile phone numbers on RocketReach.
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