Quality Assurance Project Manager
Resume:
EMMANUEL BENNETT
cell 847-***-****
**********@*******.***
SUMMARY
Results oriented, well-organized Operations Manager with international experience. Managed
plant startup activities, technology transfers, and routine production issues for domestic and
international facilities. Shown initiative in identifying and solving problems. Provided leadership
and direction to a matrixed corporate organization.
PROFESSIONAL EXPERIENCE
Abbott Laboratories, Abbott Park, IL 2004 – 2011
A global pharmaceutical company with sales of nearly $31 billion/year.
Quality Engineer – Quality Assurance R&D (2008 – 2011)
Providing Quality Assurance support to Clinical Packaging Operations.
• Approved all clinical supply related documentation, including commodity specifications,
clinical packaging specifications, complaints, Clinicopia package requests, packaging
instructions, label designs and releases, QA procedures, and final batch records.
• Improved efficiency of QA Packaging line support by 5% through reduction in time
spent performing load checks which contributed to overall team improvements of 9.76%.
• Provided QA support to packaging lines. Prevented potential recall situation through
discovery of missing protocol number on label during bottling run.
Project Manager, Operations – Quality Assurance R&D (2004 – 2008)
Provided business and operational support to Quality Assurance department.
• Managed $25 million annual budget for Vice President and Directors of R&D QA for a
population of 176 QA employees. Provided monthly analysis to QA senior staff in order to
assure budget targets were met.
• Provided workload demand estimates for projects based on models developed for
various QA areas. Accuracy of estimates generated 8% annual increase in headcount for
three consecutive years. Monitored demand estimates by comparing monthly actuals to
department capacity in order to assess additional headcount needs.
• Evaluated office operations workflow, following Lean Six Sigma principles, to assure
administrative processes were more efficient and customer focused. Office space needs
evaluated based on hiring decisions and implemented in coordination with Facilities
Management.
EMMANUEL BENNETT Page Two
PFIZER (formerly Pharmacia/Monsanto/Searle), Skokie, IL 1982 – 2003
A global pharmaceutical company with sales of nearly $50 billion/year.
Corporate Quality Assurance (QA) Manager, API Operations (1998 – 2003)
Provided Quality Assurance guidance to wholly owned US chemical facilities, contractors,
vendors, and to Research and Development projects.
• Achieved 100% compliance with all FDA and international regulatory commitments
across three chemical plants for the production of Celebrex, a $3 billion per year product.
Resolved a variety of quality issues worth over $4 million per year. Led QA project teams of
up to 7 people.
• Managed quality assurance relationship with 8 international vendors supplying
critical raw materials for Celebrex. Assured uninterrupted supply in order to produce up to
800 metric tons of Celebrex per year. Negotiated quality agreements and resolved quality
issues.
• Implemented QA requirements for outsourcing Celebrex. Negotiated quality
agreement for $50 million manufacturing contract, reviewed all technology transfer
documents, and approved reports. Primary contact for all QA issues.
Other Significant Accomplishments
Improved readiness for FDA inspection of company acquired, Belgian facility. Served as on
•
site GMP Consultant during a 1-year overseas assignment.
• Wrote manufacturing instructions for start up of Nutrasweet facility in Augusta, Georgia
during six-month assignment.
• Managed global QA database containing critical information about all drug products
manufactured. Increased accuracy of database by 30%.
• Reviewed drug product manufacturing contract agreements for QA management. Reduced
cycle time by developing contract templates.
• Completed plant improvement projects as chemical engineer, wrote standard operating
procedures, and served as an integral part of a new chemical plant start up.
EDUCATION
MBA, Operations, DePaul University, Chicago, IL
–– Delta Mu Delta Honor Society
BS, Chemical Engineering, Illinois Institute of Technology, Chicago, IL
–– Tau Beta Pi Honor Society
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