Jay Atkinson Location
- Greenfield, Indiana, United States
Jay Atkinson Work
- 2010 - 2011 Principal Quality Assurance Consultant @
- 2001 - 2005 Member – Board of Directors @
- 2013 - 2013 Senior Quality Assurance Consultant @
- 2012 - 2012 Senior Quality Assurance Consultant - Engineering Validation @
- 2019 - 2019 Interim Validation Manager and Supervisor of the Validation Department @
- 2017 - 2018 Quality Assurance Investigation Consultant @
- 2017 - 2017 Quality Assurance Consultant – Person-in Plant (PIP): CMC Biologics @
- 2012 - 2012 Principle Consultant - Aseptic Area Qualification @
- 2011 - 2012 Senior Quality Assurance Consultant @
- 2011 - 2011 Principal Quality Assurance Consultant – DEA Regulatory Compliance @
- 2007 - 2009 Manager – Quality Control and Continuous Quality Improvement @ Inspire Pharmaceuticals, Inc.
- 2006 - 2007 Quality Assurance Manager and Interim Quality Control Manager @ Gorbec Pharmaceuticals, Inc. (Formerly Eno River Laboratories – Listed Below)
- 2005 - 2006 Quality Assurance Manager @ Eno River Laboratories, LLC (Later Became Gorbec Pharmaceuticals, Inc. – Listed
- 2003 - 2005 Quality Assurance Specialist III @ Chiron Corporation
- 2002 - 2003 Analytical Research Scientist @
- 2016 - 2016 Quality Assurance Consultant – Winery Manufacturing Operations and Vineyard Management @ Raffaldini Vineyards And Winery LLC
- 2016 - 2016 Project Manager - Quality Assurance Compliance Team Leader @
- 2015 - 2016 Senior Consultant - Subject Matter Expert (SME) - CFR Title 21 Part 11 Compliance @ Abbott Lboratories
- 2015 - 2015 Senior Consultant - Validation Quality Engineer @
- 2015 - now President and Senior Consultant @ BlueSky Quality Consulting, LLC
- 2017 - 2017 Quality Assurance Consultant – Vineyard Management @ Westbend Vineyards and Winery
- 2009 - 2015 Company President and CEO @
- 2014 - 2014 Senior Manufacturing Quality Consultant (SME - Foreign Particulate Matter) @
- 2013 - 2014 Senior Quality Assurance Consultant @
- 1996 - 1999 Quality Control Chemist II - Quality Control Laboratory Manager Designee @
- 1994 - 1994 Analytical Chemist @
- 1991 - 1991 Development Assistant @
- 1986 - 1990 Science Department Laboratory Instructor @ Methodist University - Departments of Biology & Physics
- 1981 - 1985 Signal Warfare Voice Intercept Advisor (Chinese Mandarin and Spanish) @ United States Army, 7th Special Forces Group, 1st SOCOM, SOT-A Team
- 2000 - 2001 Quality Control Manager @ POINT Biomedical Corporation
- 1999 - 2000 Quality Control Laboratory Supervisor - Senior Quality Control Chemist @ POINT Biomedical Corporation
Jay Atkinson Education
- The University of East-West Medicine
L.Ac., DAOM, Clinical Program (Traditional Chinese Medicine and Chinese Herbology)
2000 - 2004 - American College of Traditional Chinese Medicine
L.Ac. (Traditional Chinese Medicine and Chinese Herbology)
1994 - 2000 - The Brody School of Medicine at East Carolina University
M.D. (Medicine)
1990 - 1994 - Methodist University
Associate of Science (A.S.) (Psychology)
1986 - 1990 - Methodist University
Associate of Arts (A.A.) (Chinese Mandarin Language)
1986 - 1990 - Methodist University
Bachelor of Science (B.S.) (Chemistry)
1986 - 1990 - Methodist University
Bachelor of Science (B.S.) (Biology/Biological Sciences, General)
1986 - 1990 - Fayetteville State University
Pre-Medical School Coursework (College Physics I, II, and III with Laboratory)
1988 - 1988
Jay Atkinson Skills
- FDA
- GMP
- Pharmaceutical Industry
- Quality Assurance
- Validation
- Laboratory
- Biotechnology
- Lifesciences
- GLP
- Pharmaceutics
- Biopharmaceuticals
- Stem Cells
- Cell Culture
- Technology Transfer
- Quality Control
- Drug Discovery
- Molecular Biology
- Clinical Development
- Cell Biology
- Immunology
- Regulatory Affairs
- Quality Auditing
- LIMS
- Quality Management
- Stem Cell Technology
- Adult Stem Cells
- Cell
- Wing Chun
- Sop
- Drug Development
- Medical Devices
- R&D
- Quality System
- Supplier Quality
- Internal Audit
- External Audit
- Auditing
- DEA
- Drug Product
- Drug Delivery
- Laboratory Medicine
- Biochemistry
- Microbiology
- Cellular Assays
- Molecular & Cellular Biology
- Commercialization
- Clinical Trials
- 21 CFR Part 11
- Vaccines
- GCP
- Production Equipment
- Mergers and Acquisitions
- Trending
- Microsoft Excel
- Analytical Instruments
- Digital Preservation
- Data Integrity
- Site Inspections
- Fiscal Policy
- Temperature Controlled
- Master Control
- Plates
- Reports
- Procedural
- Deviations
- Work Practices
- Articles
- Start Ups
- Impurities
- Military Operations
- Process Equipment
- Shipping
- FIX Protocol
- Slim
- Streams
- TOC
- Summary Reports
- Translation
- IR
- Biologics
- CAD
- Wellbeing
- Coordinated
- ISO 9001
- Strategies
- Process Improvement
- Art
- Root Cause
- Pharm
- SIGINT
- Remedies
- Dmf
- USP
- Vendors
- NDA
- Methodology
- Spanish
- Project Planning
- Foreign Internal Defense
- Class 1
- Federal Regulations
- Digital Imaging
- Test Methodologies
- GPC
- Law Enforcement
- Units
- Interviews
- Writing
- Chemistry
- Materials
- Visual Inspection
- Evaluation
- Risk
- Bioreactor
- Spectrum
- Reporting Systems
- Medicine
- Cleaning
- Lecturing
- Field Work
- SCI Clearance
- Batch Records
- Circumstances
- Phase
- Equipment Qualification
- Open Source Software
- Third Party
- Emerging Technologies
- Empower
- Site Management
- Software
- ANDA
- Binders
- Presentations
- Injectable
- Staff Augmentation
- Generators
- Sampling
- Substance
- Cabinet
- cGMP manufacturing
- Initiation
- Patient Outcomes
- Google Groups
- Distress
- Capsules
- Aseptic Processing
- Scheduling
- Metrics
- Corporate Governance
- Public Relations
- TLC
- Kansas City
- Reconnaissance
- Dispositions
- Clean Rooms
- Life Sciences
- Environmental Testing
- Travel
- Bulk
- Member of a Team
- Grading
- Fed
- Ima
- UV
- Military Training
- On Site
- Databases
- Chicago
- Characteristics
- Service Organizations
- Signal
- Gcs
- Cellular Communications
- Instruction
- Data Storage
- Product Development
- Direct Experience
- Laboratory Equipment
- Undergraduate
- Mammalian
- Research
- Blood
- Facilities Management
- ISO
- Commercial Real Estate
- SOP authoring
- Production Schedules
- Characterization
- Lotions
- Education
- Guidelines
- Lc Ms
- Meetings
- Internal Controls
- Cleaning Validation
- Project Portfolio Management
- Human Resources
- Company Operations
- Distribution Strategies
- Physics
- Voice
- FTIR
- Packaging
- Subject Matter Experts
- Rivers
- 24 Hours
- Computer Program
- Coordination
- Palo Alto
- Documentation
- Regenerative Medicine
- Set Priorities
- Military
- Hydrogen
- Cell Lines
- Programming Languages
- Creams
- Psychology
- Diffraction
- Responsibility
- Mandarin
- Contract Manufacturing
- Quality System Compliance
- Policy
- Container
- Inspiration
- Biotechnologies
- Quality Consulting
- Production Processes
- Quality Investigations
- American
- Support Documentation
- Guidance
- Karl Fisher
- GAP
- CAPA
- Std
- Particle
- Opposition
- Destruction
- Pfizer
- Coordinate
- Advocates
- Electronics
- Archives
- Documentation Practices
- Stability Studies
- International
- Usa
- Science
- Sizing
- 21 CFR
- Robotics
- Design
- Experimentation
- Business Intelligence
- UV/Vis
- Transferring
- Laser
- Remediation
- Training Programs
- Spotting
- Cost
- Applications
- Representation
- Limits
- Drafting
- Treatment
- Environmental Protection
- HPLC
- OOS
- Formulation
- Clinical Research
- Philosophy
- Testing
- Imaging Technology
- Continuous Improvement
- Parties
- Microsoft Word
- Incident
- Code
- Quality Improvement
- Execution
- Microwave
- Mentoring
- Computer System Validation
- Wet Chemistry
- Failure Analysis
- Analytical Systems
- Nsa
- Directing
- Customer Satisfaction
- Executive Management
- Scientific
- Developmental
- Consulting
- Diagnostics
- Insurgency
- Respiration
- Direct Action
- Biology
- Multinational
- ICH guidelines
- Business Process
- Molecular and Cellular
- Intercept
- System
- Budgets
- Blends
- Academic Institutions
- EMA
- Manufacturing Operations
- Plate
- Radio
- Sot
- Organizational Structure
- Manhattan
- Tablets
- Site Visits
- On Call
- Chemists
- Reviews
- Gel
- Agilent
- Victims
- Database Administration
- SAN
- Analysis
- Molecular
- Caliber
- Regulatory Agencies
- Special Operations
- Polymers
- Inspection
- Instrumentation
- MW
- Revision
- Lod
- Addressing
- Program Management
- Chemical
- Raw Materials
- Investigation
- Ultrasound
- Regulatory Requirements
- Bridge Inspection
- Regulatory Submissions
- Supplies
- Transmissions
- Parenteral
- Optimization
- Engineering
- Dissolution
- Operating Systems
- QoS
- SME
- ISO 13485
- Novartis
- Technical Writing
- Powder
- Active
- Arranging
- Sample Preparation
- Analytical Chemistry
- ROOT
- Contractual Agreements
- Financial Statements
- Dec Alpha
- In Process
- Banking
- Policies and Procedures
- Compliance
- Schedules
- Supplements
- Batch Processing
- Calibration
- Weight
- Analytical Equipment
- Sage Act
- Risk Assessment
- Labelling
- Written
- Services
- Location
- Suitability
- National Security
- Molecular and Cellular Biology
- OSHA
- Pharmaceutical Consulting
- Lap
- Conferences
- Strategy
- Utilization
- Cfr
- Oversight
- Stability Programs
- Training
- Remedial
- Marketing
- Acceptance Criteria
- Fermentation
- Bathrooms
- Integration Projects
- Other Media
- Stability
- Safety
- Environmental Analysis
- Intelligence
- CMC
- Marketing Materials
- Manufacturing
- Assurance
- Data Recovery
- Analytical Techniques
- Qualification
- Project
- Test Equipment
- EPA
- Supports
- Wound Care
- Dissemination
- Chinese
- Pages
- Laptops
- Gas Chromatography
- Aseptic
- Operations
- Scripting
- Regulatory Compliance
- CLIA
- Management
- Project Teams
- Ratios
- Corporations
- Students
- Yahoo
- Analytical Method Validation
- Environmental Monitoring
- Business Services
- Monitors
- Tank
- Automation
- Regulations
- Subject Matter Expert
- Business Expansion
- Army
- Manuals
- Provision
- Reporting
- Data Review
- Disruption
- Phase Ii
- Product Analysis
- Gaps
- Surface Tension
- Surfactants
- Aerosol
- Assessment
- Testers
- Phoenix
- Advertising Agency
- Technical Operations
- Purchasing
- Method Development
- Information Management
Jay Atkinson Summary
- Jay Atkinson, based in Greenfield, Indiana, United States, is currently a President and Senior Consultant at BlueSky Quality Consulting, LLC. Jay Atkinson brings experience from previous roles at Hospira, Inc., The University of East-West Medicine, Teva Pharmaceuticals, Inc. and Pfizer, Inc.. Jay Atkinson holds a 2000 - 2004 L.Ac., DAOM, Clinical Program in Traditional Chinese Medicine and Chinese Herbology @ The University of East-West Medicine. With a robust skill set that includes FDA, GMP, Pharmaceutical Industry, Quality Assurance, Validation and more. Jay Atkinson has 2 emails and 3 mobile phone numbers on RocketReach.
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