ki-profile: Tarek Elneil
Over 11 years in continuous quality improvement, I have been a change agent specialized in building FDA compliant information systems in the Biotech and Pharmaceutical industries. Through my work, I can confidently claim that I have saved millions of dollars for the companies that I have worked for. I accomplished those savings by utilizing my experience in Six Sigma, Lean Manufacturing and problem solving tools. I have led and trained cross functional teams to improve quality and have conducted Kaizen events My accomplishments have been recognized by top management and I received the “Value in Action Award” from Baxter. I am a Certified Manager of Quality and Organizational Excellence, Senior member, and the Program Chair of The American Society For Quality, San Fernando Valley. I am a Six Sigma Engineer and Green Belt Trained.
Quality Management Tools, Moorpark, California
March 05 to June Present
• Provided consulting services in Quality Assurance and Quality control to ensure compliance and product quality in the following areas:
o Information Systems for Production and Quality. System analysis and database design.
o Document Control
o CAPA (Corrective Action Preventive Action) program.
• Lean Manufacturing and Six Sigma Training
• Quality systems harmonization and compliance
• Performance and Dashboard Metrics development.
Cardinal Health, Albuquerque, New Mexico (Cardinal Health is a Fortune 100 Company with over 40,000 employees’ world wide. The Pharmaceutical Technologies and Services division is a contract manufacturer of pharmaceutical drugs)
Sep 05 till July 06
QA CAPA Investigator
• Managed quality harmonization project, where I led a team tasked with standardizing Cardinal Health PTS division quality systems. The project covered three facilities Albuquerque, Woodstock, and Raleigh. The project was successful in standardizing 24 quality systems and was completed within 6 months.
• Led project to improve the trending and tracking of deviations criteria (TrackWise) Database
• Review and coordinate the completion of CAPA investigation.
• Manage Quality Improvement projects.
• Participated in the weekly CAPA meetings
Baxter BioScience, Thousand Oaks, California (With 46,500 employees, Baxter is a leading manufacturer of plasma-based and recombinant proteins ($ 4.8 Billion in sales in 2007) used to treat hemophilia )
Jan 01 till Dec 04
Associate Quality Engineer (QLP Associate)
• Built Project Management database to track the facility projects, and archive the project documentation.
• Prepared Lean Manufacturing training manual. Participated and led a Lean Manufacturing Process team to identify cost savings through the following projects: Volume Optimization, Line Loss, and Shift Optimization.
• Participated on several problem solving CAPA (Corrective Action Preventive Action) teams, which identified process improvement projects. Led cross-functional teams utilizing the tools of Six Sigma to identify root causes and solution:
• Led continuous improvement projects Autoclave investigation:,Needle Intervention, SMEJA (vial cap sterilization unit), Kaizen team to reduce facility non-conformance (Deviation Notice Reduction) ed the Green Belt Project for HPLC (High Pressure Liquid Chromatography) Cycle Time Reduction
• Prepared and published the facility Dashboard metrics on a monthly schedule.
• Managed quality improvement projects.
• Trained new hires and existing employees on continuous improvement methodology and problem solving tools.
• Collected and published the monthly facility and division metrics.
• Organized and coordinated the QLP events.
Baxter BioScience, Thousand Oaks, California
January 98 till December 2000
• Participated in implementing and validating the implementation of Part 11 (Electronic Records and Electronic Signature), and prepared for LIMS (Lab Information Management System) implementation in the QC Lab ; prepared report defining the QC Lab User Requirements for the Lab Information Management System.
• Reorganized Sample Control in the Quality Control Lab improving unit efficiency by 300%. Proposed and implemented a Sample Reduction Program in 2 phases that saved the company over 2 million Activity Units a year.
• Established a lab archiving system and prepared procedures and forms that improved the lab usage area.
• Built several databases ranging from Sample Control, Raw Material, to Microbiology and more
• Organized and led the Sample Control.team
• Managed the Document Control Unit
• Published the monthly Quality Control metrics
California Lutheran University, Thousand Oaks, California
Master of Business Administration 1980
Kuwait University, Kuwait
B.Sc Zoology and Biochemistry 1978
Green Belt Baxter SQL LIMS 3.1 Key Personnel PE Nelson
Mastering Lean Tools Baxter Total Quality Management Kavlico
Life Cycle Development and Validation of Computerized System Baxter Postgraduate Studies in Biology CSUN
Web Page Design Moorpark College Compensation and Benefits UCLA Extension
MS Office Suite (Word, Excel, Access, Power Point) MS Visio 2000
MS Projects 2000 Dreamweaver MX
Six Sigma Quality Improvement
my posted projects
In ki work since:
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