John S. Allen
309 Washington
 Highland Illinois 62249
314-422-5724
 

Professional Summary

A quality and operations professional with extensive knowledge in the planning,
deployment and sustaining of Lean Six Sigma initiatives within the pharmaceutical
industry. Proven results with a hands-experience dealing with total plant
re-engineering based on utilizing six sigma to monitor cycle time for production
over 25 years of experience within the medical / pharmaceutical industry. More
than 20 years of experience in high volume pharmaceutical and consumer products,
quality, operations and people development. A fast track, highly motivated,
dedicated and team oriented professional that puts people first. 

Areas of Expertise

 *  Six Sigma Green Belt - Lean Six Sigma  *  Solid/Liquid Dosage  * 
Validations 
 *  Out of Specification Investigator
 *  Control Chart Analyst  *  Calibration Specialist  *  HPLC Separation
Specialist 
 *  Metallurgical testing experience
 *  Project management: production improvement (cycle time)
 *  Quality assurance(GMP)  *  Metrics  *  Lab Information Systems  *  Quality
Engineering 

Professional Experience

Mallinckrodt Chemical (Covidien), St. Louis, Missouri (04-1988 to 12/2008)
Chemist-final product
Responsible for: final product testing, daily inventory control of narcotics for
the analytical unit;
tracking quality and regulatory commitments for timely completion; and the
identification, and
sustainment of all continuous improvement initiatives related to the analytical
laboratory.

Lean Six Sigma leader 
Responsible for: identification, implementation and sustainment of all
improvement initiatives
related to the raw material process laboratory.
 *  Planned, directed and sustained the lean initiative to reduce all compliance
issues by 20%
Within the third quarter. Implemented dashboard metrics utilizing visual
displays.
Corporate audit team gave us highest rating for the display. The team is a 
Functional team of all areas of organization.
 *  Cross-functional team lead for cycle time reduction by evaluating value
added
activities in maintance projects related to production activities.

 *  Served as the primary instructor for continuous improvement program for the
laboratory group. 
Also Instructed daily sessions for the production employees in the use of Lean
Six Sigma methodologies. Mentored and coached personnel in identification,
selection, implementation and sustainment of the project.

 *  Established and managed quality metrics which was reviewed weekly. VOC and
QFD methodology was used to identify KPIs for cycle time of products.

Senior Chemist leader 
Responsible for daily activities of the improcess chemistry laboratory when
management is not available.

 *  Planned, managed and sustained the laboratory  ™s SPC and TQM programs. 
 *  Weekly review of control chart data with the group
 *  Development of daily communication sessions
 *  Maintain physical inventory, and calibrated equipment to meet the needs of
production
 
Plant re-engineering analyst (Process Validation Engineer)
 *  Utilized Six sigma tools to identify primary areas of accumulated waste.
Member of team of
12 cross-functional quality and production personnel that utilized gap analysis
that tracked
Changeover procedures, line clearance and predictive maintenance programs.
Utilized Value Stream 
Mapping as the primary tool for the elimination of constraints wihin the product
life cycle.
Performed both safety, and validation of process equipment and chemical lines in
main facility.

Analytical chemist: 
 *  Performed analytical chemistry on final and improcess narcotic samples for
product release. Following cGMP guidelines. Act as a technical reference to
production needs on the off shifts when problems develop. Perform a modified CAPA
analysis on problems as they develop.

Education
BSC, Chemistry and Mathematics, Southeast Mo. State University, Cape Girardeau,
Missouri 
ASQ certification: Quality Improvement Associate 2004
FMEA certification: Project management 2004
Lean Sponsor: project management instructor
Yellow and Green Belt six sigma trained and certified
** Currently Pursuing: ASQ training in black belt, and CQE for certification
exams