Kevin Howerton

About Kevin Howerton

Business Professional with 20-years experience in the Biotech, Pharmaceutical and Medical…

Experience

1. Senior Supervisor, Manufacturing Quality Assurance

   Pfizer

   Aug 2012 — Present

   Responsibilities •Oversee floor operations in the manufacture of injectable drugs and medical devices •Manage staff of Quality Engineers and Specialists: hire, train and mentor •Enforce national and international cGMP regulations: DEA, FDA, TGA, EMA, Health Canada, ISO 9001:2008, ISO 13485, ICH Q7-10, 21 CFR parts 210, 211, 810 and 820 •Serve as Subject Matter Expert in Solution Preparation, Aseptic/Terminal Sterilization and Isolator Filling, Labeling and Packaging of sterile injectable drugs and medical devices •Oversee manufacturing support functions including: Supply Chain/Warehousing, Facilities, Maintenance, Sanitation, Validation, Engineering, Instrumentation, Biological Quality, Chemical Quality, Documentation, Batch Record Quality, Investigations, and Training •Initiate, review and approve investigations in Trackwise: risk assessment and management, root cause analysis, implementation of Corrective and Preventative Action •Approve product release, initiate Field Alerts/Recalls, Notification to Management (NtM) •Represent organization to internal and external auditors and Regulatory Agencies •Continual Improvement Process initiatives including Six Sigma, 5S, Lean and Kaizen •Align corporate and site requirements with industry guidelines and standards •Implement Quality metrics and standards using Statistical Process Control (SPC) Accomplishments •Quality Incentive Program (QIP): designed and implemented •Updated AQL Sampling Plan according to ANSI/ASQ Z1.4 standards •Implemented pre-label inspection process for syringe products •Assisted in achieving VAI status through successful FDA audit with zero observations •PDA trained and Quintiles certified for Quality Assurance oversight

Skills

• Fda
• Scale-Up
• Team Building/Management
• Lean Manufacturing
• Six Sigma
• Biopharmaceuticals
• Process Simulation
• Change Control
• Gmp
• Glp
• Lifesciences
• Dna
• Supply Chain Management
• Corrective and Preventive Action (Capa)
• Kaizen
• Capa
• Gene Expression Profiling
• Production Management
• Process Development
• Quality Assurance
• Pharmaceutical Industry
• Sop
• U.s. Food and Drug Administration (Fda)
• Good Laboratory Practice (Glp)
• Medical Devices
• Synthetic Biology
• Genomics
• Customer Service
• Anova
• Project Management
• Dna Sequencing
• Aseptic Processing
• Biotechnology
• Laboratory
• Product Support
• Molecular Biology
• Validation
• Process Automation
• R
• Standard Operating Procedure (Sop)