Quality Assurance Specialist

John S. Allen

*** **********

Highland Illinois 62249

314-***-****

**********@*****.***

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

· Lean manufacturing advisor/experienced

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

· 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.

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

Contact this candidate