Quality Engineer Manufacturing
Resume:
ERNIE L.K. BOONE II
DIMONDALE MI 48821
********@*****.***
SUMMARY
Results oriented Quality Engineer with 22 years experience in pharmaceutical, medical device, food, confectionary and beverage manufacturing processes. Demonstrated excellent problem solving, administrative, communication and leadership skills. Recognized by senior management for strong work ethic, the ability to resolve highly complex production and quality related issues. Supervisory and technical expertise in the following production related functions:
Quality Control Scheduling Production and Process Validation
Six Sigma/Lean Quality System Monitoring Customer Audits
Production Control Internal Auditing Prevention Maintenance /Equipment
Change Control Management Hosted FDA Developed Quality Procedures PROFESSIONAL EXPERIENCE
AMWAY, ADA, MI 2011 – 2019
BUSINESS INTELLIGENCE ANALYST 2015 – 2019
Managed the change management process for (7) manufacturing sites. Administrated the Global Document Control System for Multiple Manufacturing sites. Developed process of Final Acceptance for Product Life Cycle Management. Administrated the training for Research & Development department using Compliance Wire Software. Used Clarity to manage and schedule working hours for Amway projects. QUALITY ENGINEER 2011 – 2015
Worked as Liaison with Contract Companies to manufacture Cosmetics, Liquids, Personal Care, and OTC products
Earned Amway Green Belt in Six Sigma/ Lean activities. Plant Engineer for Cosmetics, Personal Care, Laundry, Liquids, Plastics, Paper, Pressure sites. Performed Root Cause Analysis, CAPA, FMEA, Risk Assessment, and Investigated Customer Claims. Performed Internal Audits of Manufacturing sites using Amway’s Quality Assurance Capability process. Lead Cross-functional teams, established a quality culture throughout Amway manufacturing sites. TELEFLEX MEDICAL, MT LAUREL, NJ 2005 – 2011
QUALITY ASSURANCE SUPERVISOR
Coordinated daily inspection activities for incoming, in-process, and final acceptance inspections.
Supervised 9 Quality Assurance Inspectors including staffing, evaluating and scheduling for two shifts
Lead Root Cause analysis investigations and determined corrective or preventive action.
Participated on cross functional teams within the company’s Risk Management System to perform Failure Mode and Effect Analysis.
Facilitated training of Quality System and regulatory requirements for production, manufacturing and engineering personnel.
Participated in the development of new inspection and testing procedures.
Managed nonconformance systems.
Assisted with updates and revisions of company’s product Health Hazard Analysis.
Oversaw Environmental Monitoring Testing for Class 8 clean rooms.
Lead cross functional teams working on continuous improvement projects that developed corrective actions to prevent reoccurrence of product functional failures. AMCOR FLEXIBLES HEALTHCARE, MT. LAUREL, NJ 2002 –2004 QUALITY ENGINEER
Conducted analysis on manufacturing products including coated Tyvek, ® identifying and resolving production flows resulting in potential savings of $100,000 in reproduction cost and customer satisfaction.
Created a flagging form to identify production defects and quantities of defective material at all critical stages of the manufacturing process.
Established and monitored quality partnerships and regulatory compliance (GMP, QSR) for such as Ethicon, Bristol Myers, Eli Lilly, J&J, Pharmaceutical Sourcing Group of America, Geneva, Novartis, Merck, Sharp, Anderson, P&G, Nestle and Hershey.
ERNIE BOONE Page 2
Audited vendors and established quality partnerships and certifications for large inter-national and national companies.
Performed continuous improvement of quality systems and product and process validation.
Inspected all products manufactured in the rollstock department, including extrusion, laminating, printing and slitting operations.
Insured that all inspected rollstock manufactured materials met current and appropriate manufacturing specifications.
Performed all testing quality testing, documented testing and inspection data and prepared report for senior management review.
ALCOA FLEXIBLE PACKAGING, DOWNINGTOWN, PA 1993-2002 QUALITY ASSURANCE MANAGER
Responsible for specification administration and maintained Quality Systems Manual
Rewrote and updated standards and procedures and training programs for current good manufacturing.
Monitored claims and returns determining disposition on nonconforming materials.
Managed a staff of six laboratory technicians while leading numerous customer audits PHARMACEUTICAL/HEALTHCARE PLANNER 1996- 1997
Managed production control planning for rotogravure and flexographic printing presses
Ordered raw materials and provided work instructions for manufacturing.
Created packing specifications and provided Certificates of Compliance and Certificate of Analysis QUALITY ASSURANCE SUPERVISOR 1993- 1996
Supervised nine lab technicians working on three shifts while troubleshooting lab equipment failures.
Wrote current Good Manufacturing Practices and developed pharmaceutical procedures.
Conducted performance audits on process controls and assisted in customer audits.
Managed pest control program
EDUCATION
BS, Packaging, Michigan State University, East Lansing, MI ADDITIONAL TRAINING
~ ISO 9000 ~ISO 9000 Overview ~ISO 13485
~ SPC Training ~ QSR ~ Agile
~ Pilgrim ~ Computer Aided Compounding ~ Kaizen
~ Cadence ~Six Sigma / Lean ~ Infinity QS
~BSI Medical Device Lead Auditor ~Product Life Cycle Software ~Total Quality Management
~Production Management System ~Decision Making /Problem Solving ~Project Management
~AMMI Quality System Regulation Training ~Quality Measurement and Inspection System COMPUTER LITERACY
Word, Excel, PowerPoint, One Note, Outlook, One Drive, Clarity, Skype, Webex, Compliance Wire MS Office, Mini Tab, Access, PLM, ETQ/Reliance, StarLims, Sharepoint, RedPrairie, JDEdwards,
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