|JOHN S. ALLEN
*** ********** ********, ******** ***** 314-***-**** email@example.com
QUALITY OPERATIONS LEADER
Increased Productivity / Efficiency Improved Product Quality Lean Six Sigma Expertise
Proactive, dynamic problem-solver with record of driving Lean, Six Sigma, TQM, GMP, and Kaizen methodologies to consistently improve and streamline operations in high volume manufacturing environments. Analytical leader with proven ability to pilot total operations overhauls that significantly streamline functionality. Adept at hiring, training, and piloting dedicated, focused team to achieve peak performance levels. Poised professional with superlative interpersonal and communications skills; proficient at initiating and maintaining relationships with all levels of both internal and external hierarchies. Laboratory experience includes solid / liquid dosage, control chart analysis, calibrations, and HPLC separation. Dedicated to helping achieve both short- and long-term business objectives.
Areas of Expertise
Six Sigma Yellow& Green Belt Product Testing Regulatory Compliance
Lean / Six Sigma Lean Facilitation Maintenance-Safety
Project Management Laboratory Operations Staff Training / Mentoring
QA / QC / TQM Batch Record-Review VOC / QFD / KPI
Validation Protocols Statistical Analysis-Minitab Value Stream Mapping
TERUMO MEDICAL PRODUCTS – WATLOW ELECTRICAL Saint Louis Missouri
Supply Chain Quality Engineer 2010 to Nov 2010
Project: supply chain engineering- production of heater cores for blood by-pass systems. Production slowed due to unknown reasons, failure rate increased. Arrived on site, performed a force field analysis of the process and people. Offered training for all in the unit on GMP regulations. First time right was charted and displayed as a control chart. Daily production meeting was scheduled not to last more than 30minutes. Work instruction improvements were achieved-early into the project. First time right on welding improved to 90% passing leak testing.
CHEMICAL CONSULTANT Highland Illinois
Quality Engineer 2008 to 2010
MALLINCKRODT CHEMICAL (COVIDEN) Saint Louis Missouri
$1B pharmaceutical manufacturing company 1988 to 2008
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
FMEA trained specialist, and certified
Total Chrom Validation specialist-development of test samples for system performance
Chemist – Final Product
Tested final products to ensure maintenance of quality levels. Directed daily inventory control of narcotics for analytical unit. Ensured on-time delivery by tracking quality and regulatory commitments.
Identified opportunities and spearheaded strategies for continuous improvement throughout all aspects of Analytical Laboratory functions.
Lean Six Sigma Leader
Piloted the identification, implementation, and maintenance of all improvement initiatives within raw material process laboratory.
Planned, executed and maintained Lean initiative that reduced all compliance issues by 20% within one quarter (Q3, 2008).
Implemented dashboard metrics that utilized visual displays, which improved group performance; display received highest rating from Corporate Audit Team that serves entire Company.
As cross-functional team leader for cycle time reduction, evaluated value-added activities in maintenance projects related to production activities; achieved cycle time reduction of 15%.
Served as primary instructor for continuous improvement training program targeting laboratory group comprised of 20 members and four engineers.
Conducted daily Lean Six Sigma training sessions for four building / project production employees; achieved zero rejections in start-up phase and improved “first-time-right” metrics.
Established and managed quality metrics program which was reviewed weekly; leveraged VOC (voice-of-customer) and QFD (quality function deployment) methodologies to identify KPIs for product cycle-times.
Senior Chemist Leader
Oversaw daily activities within in-process chemistry laboratory during management absences.
Planned, managed, and maintained laboratory’s SPC and TQM programs.
Led weekly review of control chart data with raw material group; meeting subsequently enhanced productivity.
Developed and implemented of daily communication sessions developed
Maintained physical inventory and calibrated equipment to consistently meet production requirements.
Plant Re-Engineering Analyst
Piloted 12 cross-functional quality and production personnel that utilized gap analysis to track changeover procedures, line clearances, and predictive maintenance programs.
Leveraged Six Sigma tools to identify primary areas of accumulated waste; achieved ~20% reduction in waste solvents by modifying methods.
Utilized Value Stream Mapping as primary tool to eliminate constraints within product lifecycle.
Performed analytical chemistry on final and in-process narcotic samples for product release.
Followed cGMP guidelines to ensure highest quality output and adherence to regulations.
Played key role as a technical reference to production needs; expedited problem resolution during off-shifts.
Conducted modified CAPA analysis on problems as they developed; eliminated recurring problems between groups
EDUCATION & PROFESSIONAL DEVELOPMENT
BS, Chemistry & Mathematics Southeast Missouri State University
ASQ certification Quality Improvement Associate
FMEA certification Project Management
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