2010 -2010 Sr. QA Ops Specialist II (Consultant) @
2009 -2010 Sr. QA Ops Specialist II - (Consultant) @
Marc Booker Education
Southern New Hampshire University
Master's Degree (Master's Degree, Six Sigma Quality)
2016
Ashford University
Bachelor of Arts (BA) (Bachelor of Arts (BA), Social Science)
Marc Booker Skills
Mitigation Strategies
Facility Start-up
Personnel Management
Immunology
Performance Monitoring
Interpersonal Skills
International Regulations
Training Programs
System Implementations
Delivery Of Projects
Escalations Management
Resource Allocation
Benchmarking
Multi-site
Team Effectiveness
Internal Audits
Clear Vision
Strategic Planning
Product Lifecycle Management
New Product Rollout
Critical Thinking
Key Metrics
Escalation Process
Peptides
Emerging Technologies
Timelines
Technical Operations
Resource Planning
CMC development
Attention to Detail
Team Motivation
Regulatory Examinations
Quality Risk Management
Manager of Managers
Industry standards
New Business Development
Strategy
Key Performance Indicators
Big-Picture Thinking
Organization Skills
Quality Compliance
Quality Operations
Quality Leadership
Cross-functional Coordination
Problem Solving
Gene Therapy
Green Loan Principles (GLP)
Creative Problem Solving
Vendor Relations
Material Review Board (MRB)
Leadership
Audit readiness
Product Development
Risk Management
GCP
Oncology
Written Communication
Clinical Trials
Project Implementation
Self-Management
Commercialization
Organizational Alignment
CAPA
Change Control
Validation
GMP
Quality Assurance
Quality System
FDA
GxP
Deviations
Process Improvement
Pharmaceutical Industry
Biotechnology
Management
Aseptic Processing
Auditing
cGMP practices
SOP development
Training
21 CFR
21 CFR Part 11
Biopharmaceuticals
Cross-functional Team Leadership
Pharmaceutics
Technology Transfer
ISO
Regulatory Requirements
Data Analysis
Change Management
Batch Release
Lean Management
Documentum
APQR
APR
PQR
Health Canada
ICH Guidelines
Consent Decree
Remediation
Trackwise
Sop
LIMS
V&V
ERP
Software Documentation
Quality Control
Computer System Validation
Regulatory Affairs
Quality Auditing
ISOtrain
Batch Records
Maximo
Cross Functional Team Leadership
FDA GMP
GLP
Marc Booker Summary
Marc Booker, based in Boston, MA, US, is currently a Vice President of Quality at Akebia Therapeutics. Marc Booker brings experience from previous roles at Genentech, Compliance X Consulting, Black Diamond Networks and Viridian Therapeutics, Inc.. Marc Booker holds a Master's Degree in Master's Degree, Six Sigma Quality @ Southern New Hampshire University. With a robust skill set that includes Mitigation Strategies, Facility Start-up, Personnel Management, Immunology, Performance Monitoring and more. Marc Booker has 3 emails and 2 mobile phone numbers on RocketReach.
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