Aura Moreno Email & Phone Number
QA Technical Reviewer @ Catalent Pharma Solutions
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Aura Moreno Location
- Riverview, FL, US
Aura Moreno Work
- 2022 -now QA Technical Reviewer @
- 2022 -now Associate Project Engineer @
- 2020 -now CSV (R and D and Commercial Manufacturing @ Pharmaceutical Solution
- 2019 -2019 Data Integrity Subject Metter Expert @ AveXis, Inc.
- 2019 -2019 Validation Engineer @
- 2018 -2018 QA Validation Engineer @
- 2017 -2018 Technical Writer @
- 2016 -2017 Team Lead Validation Engineer-Independent Consultant @
- 2014 -2015 CSV Validation Engineer @
- 2023 -now QA Technical Reviewer @
- 2014 -2014 Manufacturing Compliance Engineer @
- 2013 -2013 Validation Engineer @
- 2012 -2012 Quality Anssurance Specialist @
- 2011 -2012 Packaging Validation Engineer @ Becton & Dickinson
- 2011 -2011 Validation Engineer @ Merck Sharp & Dohme
Aura Moreno Education
- Universidad de Puerto Rico
Biotechnology (Engineering)
2004-2006 - Technology University of Panama
Computer system Engineer (Industrial)
1986-1991
Aura Moreno Skills
- Validation
- Engineering
- CAPA
- V&V
- FDA
- Quality System
- ISO 13485
- Change Control
- 21 CFR Part 11
- Computer System Validation
- GMP
- Technology Transfer
- Biotechnology
- GxP
- R&D
- Cleaning Validation
- U.S. Food and Drug Administration (FDA)
- Verification and Validation (V&V)
- Corrective and Preventive Action (CAPA)
- U.S. Title 21 CFR Part 11 Regulation
- Quality Management
- Chromatography
- Pas
- IBM
- Master Plan
- SCADA
- CAP
- ISO
- Vision Care
- Petrochemical
- Utility Systems
- Vector
- Pumps
- Machining
- Third Party
- Treatment
- FMECA
- u.s. Food and Drug Administration Fda
- Acid
- Requirements Gathering
- Design
- Impact Assessment
- Cfr
- Initiation
- Dust
- Pfizer
- PowerPoint
- Technology
- Frs
- Lean Manufacturing
- Siemens
- Human Resources
- Process Automation
- Qualification
- Dcr
- BDC
- Process Validation
- Troubleshooting
- System
- Crystal Reports
- Reactor
- Tank
- Mixed
- Compounding
- Puerto Rico
- Policy
- Computerized Systems
- Feeds
- Diabetes
- Scripting
- Decommissioning
- Part 820
- Documentation
- Project Management
- Building Management
- Test Planning
- C
- Coordination
- PFMEA
- Communication
- Customer Needs
- Active
- Safety
- Purification
- Filtration
- Change Management
- Facilities Management
- Consent
- ESS
- Statistical Software
- HACCP
- Responsibility
- Process Equipment
- Six Sigma
- Usa
- Internet Explorer
- Injection Molding
- Regulations
- International
- Control Charts
- Estimate
- Purified Water
- Start Ups
- Banding
- Technical Design
- Guidelines
- Diagnostics
- Raw Materials
- Corrective and Preventive Action Capa
- Compliance
- Microsoft Word
- System Integrity
- Pharmaceutics
- Computer Technology
- Risk
- Software Validation
- Automation
- Major Areas
- Writing
- Identify Trends
- ICT
- Filter
- Incubators
- Cycles
- Consent Decree
- Failure
- Pharm
- Qas
- Building Management Systems
- SME
- PC
- PAC
- GLP
- Metrics
- Auditing
- Functional Requirements
- Blood
- Approvals
- Media Preparation
- RTU
- Guidance
- Networking
- Data Validation
- Local Area Network
- Bosch
- Manufacturing Operations
- Cleaning
- Reports
- Documentation Practices
- Account Reconciliation
- Containment
- Testing
- Project Coordination
- Disaster Recovery
- Solution
- Supply
- System Monitoring
- Chillers
- Investigation
- Controller
- Environmental Monitoring
- Inspection
- Advertising Agency
- Solvent
- Systems Analysis
- Producing
- Gamma
- SAP
- CIP
- Trials
- Ubd
- Management System
- GAMP
- FIX Protocol
- Cognos
- Specs
- APC
- Intel
- Lead a Team
- Quality Assurance
- OOS
- Risk Assessment
- Oxygen
- USP
- Time Management
- Project Planning
- SAT
- Documentum
- Plants
- OSHA
- Presentations
- Prs
- Media
- Utility
- Fault Tree Analysis
- Centrifuge
- Cisco Technologies
- Health and Safety
- Efficient
- Heat
- Lotus Notes
- Programmable Logic Controller
- Microsoft SQL Server
- Machine Tools
- IBC
- Procedure Manuals
- Process Improvement
- Validating
- Fermentation
- Requirement Specifications
- Compress
- Internal Controls
- Occupational Therapy
- Formulation
- Culture
- Staff Development
- System Testing
- Automatic
- Evaluation
- Lyophilization
- DP
- Coordinated
- MHRA
- Databases
- Process Manufacturing
- Urs
- Traceability Matrix
- Chemical
- Surgery
- Units
- Chi Square
- Vendors
- System Life Cycle
- Functional Specifications
- Serving
- SAN
- Construction
- APIs
- Deviations
- Traceability
- Organizational Structure
- Florida
- Apogee
- Texas
- Feasibility Studies
- Delta V
- German
- Poms
- Field Execution
- Integration
- Sop
- Plates
- Analyzer
- Equipment Qualification
- OTC
- Healthcare
- Tests
- ISO 9001
- Strategy
- New Process
- Supervision
- Microsoft Office
- Risk Analysis
- Rockwell
- Technical Teams
- Microsoft Excel
- Glass
- Technical Reports
- Clean Rooms
- Manufacturing Processes
- Fbd
- Analysis
- PPC
- Laboratory
- Verification and Validation V&V
- Process Qualification
- Chemical Plants
- Operating Systems
- Implications
- Applications
- Data Analysis
- Change Readiness
- Mechanical
- FMEA
- Cell Culture
- Water Treatment
- Opl
- User Requirements
- SIP
- Characterization
- Regulatory Requirements
- Suite
- Weight
- Document Management
- Autoclave
- Remediation
- Project
- Change Requests
- Ancillary
- Council
- Packaging
- Code
- Bioreactor
- Root Cause Analysis
- Unit Testing
- Inductively Coupled Plasma
- Warehousing
- Commissioning
- Forms
- Reviews
- HVAC
- Investments
- Without Supervision
- Confined Space
- Bulk
- Moc
- Test Scripts
- Panama
- Tubes
- Tablets
- Unlimited
- Controlling
- Sampling
- ICP
- Calibration
- Medical Equipment
- Sterility
- Gaps
- CSV
- Consulting
- Verifications
- Corrective Actions
- Nasal
- Coatings
- Data Mapping
- Minitab
- Utilities
- Admin
- Batch Processing
- Design of Experiments
- Mixing
- Assessment
- Fat
- Validation Reports
- Management
- Modification
- MES
- Data Backup
- Spray
- Cgmp's
- Water Systems
- Human Machine Interface
- 21 CFR
- SDLC
- Execution
- Systems Engineering
- HPLC
- Seminars
- Cell
- Data Recovery
- Fillers
- Agreement
- Multi Level
- Revision
- PV
- Training
- R&r
- Root Cause
- Compaq
- Subject Matter Expert
- Quality Control
- Dry
- Harvest
- Steam
- Systems Design
- Sterilization
- Design Control
- Tanks
- Controllers
- Project Plans
- Schedules
- Laboratory Equipment
- Novartis
- Operations
- Summaries
- Stage
- Commercial Products
- CTP
- Business Intelligence
- Technical Support
- Microsoft Certified Professional
- WiFi
- Data Migration
- Blender
- Inspectors
- Computer Proficiency
- Credibility
- Valves
- Distribution
- Allergy
- Executions
- Electronics
- Bottles
- ICH guidelines
- Windows Vista
- Visio
- Medical Devices
- Software
- Granulation
- Columns
- Factory
- Honeywell
- Implantation
- Work Instructions
- Phase
- Limits
- Provox
- Test Cases
- Business Process
- Manufacturing
- Aura
- Summary Reports
- Quality Improvement
- Process Design
- Retirement
- Mixers
- Piping
- Nitrogen
- u.s. Food and Drug Administration
- Verification and Validation
- Corrective and Preventive Action
Aura Moreno Summary
- Aura Moreno, based in Riverview, FL, US, is currently a QA Technical Reviewer at Catalent Pharma Solutions. Aura Moreno brings experience from previous roles at Catalent Pharma Solutions, Pharmaceutical Solution, AveXis, Inc. and Pfizer. Aura Moreno holds a 2004 - 2006 Biotechnology in Engineering @ Universidad de Puerto Rico. With a robust skill set that includes Validation, Engineering, CAPA, V&V, FDA and more. Aura Moreno has 2 emails and 3 mobile phone numbers on RocketReach.
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