Quality Assurance Management

*** **** ****** ***** ****** L. FLEMING

270-***-****

Henderson, KY 42420 abj6f5@r.postjobfree.com

QUALIFICATIONS SUMMARY

. Quality Director with Lean Manufacturing training

. Strong background in quality assurance/control, printing, automotive,

metal stamping, and cGMP requirements

. Knowledgeable in requirements and sensitivity to pharmaceutical printed

packaging components

. High energy director who takes a logical, problem solving approach to

all challenges

. Multi-site management responsibilities

. Adaptable to change and comfortable in any technical environment

. Planned and implemented computerized Corrective Action database for

multiple sites

. Passionate about Safety having been the Plant Safety Coordinator in a 0

injury plant for 3 years

. Develop, coordinate, conduct training seminars including Lean

Manufacturing

. Training Certified Lean Manufacturing Expert

Supervisory Leadership

Statistical Process Control

Certified ISO 9001:2008 Lead Quality Auditor

Time Management

Essential Skills for Managing Projects

PROFESSIONAL EXPERIENCE

Keller Crescent Company Evansville, IN Corporate

Director of Quality Assurance 9/2006-11/2009

Executive oversight of Quality Assurance departments in multiple sites:

Evansville, IN; Charlotte, NC; and Indianapolis, IN; manufacturing cartons,

labels, and literature inserts/outserts primarily for the pharmaceutical

industry (95% of the business) as well as the cosmetic, liquor, and tobacco

industries. Reported to the CEO.

Daily Responsibilities:

. Supervised the Quality Managers directing budgets, projects, tasks, and

department goals

. Oversaw resource management including personnel, equipment, and software

. Responsible for compliance to PS9000 QMS: include cGMP requirements and

ISO9001 compliance

. Internal audit coordinator

. Client liaison during external audits, executive level quality meetings,

and high impact line issues

. Audited suppliers for compliance to strict GMP requirements for material

management and quality

. Provided metrics regarding quality trends to production and clients

. Decision-maker for internal projects to enhance quality

. Responsible for efforts to create and maintain a culture of continuous

improvement

. Coordinated implementation of established QMS in acquisitions of sister

plants

Achievements:

. Trained production personnel on 5-Why RCA in one facility resulting in a

59% decrease in internal issues

. Trained production management in RCA techniques relating to CAPA

resulting in a 33% decrease in external issues

. Trained production management in Lean Techniques resulting in better RCA

and visual management of production

. Passed all pharmaceutical client audits with few to zero findings

leading to new business as well as sustained business

. Year-over-year quality improvement overall for every plant under my

direction

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Toyota Motor Manufacturing Princeton, IN

Assistant Quality Manager 7/2005-9/2006

Responsible for the management of daily activities in the Receiving

Inspection (supplier parts quality), In-line Inspection (manufacturing),

and Vehicle Performance (final manufacturing and performance testing of all

vehicles) departments for the Tundra and Sequoia lines.

. Supervised 6 Group Leaders (2 per area) during all daily production

. Coordinated overtime with production needs

. Investigated issues including in-line flow-out of defects as well as

containment activities

. Reported on quality metrics daily to Toyota executives

. Responsible for employee safety awareness program

. Implemented a Customer Satisfaction group that performed 100% inspection

of all aspects of audited vehicles

. Responsible for designing inspection points and methods for enhanced

inspection for J.D. Power awards production

. Performed Jishukens directed at minimizing strenuous activities for team

members

. Responsible for Quality Production Inspection team member HR issues

. Wrote, implemented, and directed large containment activities that

included parts replacements

Sonoco Products Company Henderson, KY Production Supervisor & Plant

Safety Coordinator 6/2002-6/2005

Responsible for all aspects of production on 2nd shift from materials

management, quality inspection, and production of metal ends (aluminum and

steel) to safety, shipping, and team member scheduling. Production included

conversion of aluminum coils and steel sheets to ends for cans in the

consumer goods sector: tennis balls, baby formula, coffee, peanuts, grease,

etc. Worked in a cGMP environment.

. Supervised 2nd Shift Production, Maintenance, and Shipping Crews for 19

production lines

. Managed production lines to meet efficiency, productivity, and scrap

goals

. Coached and developed 25 employees through annual reviews and daily

interaction

. Developed yearly safety process to comply with OSHA, Corporate, and

Plant rules and regulations

. Coordinated training sessions for safety and new employee orientations

. Lead presentations on plant safety process for customers and corporate

reps for benchmarking

. Lead plant safety coordinator team

. Lead a QC Kaizen that reduced rejections and improved Quality Technician

efficiencies

Quality

Associate Intern 1/2002-6/2002

. Participated in Six Sigma optimization projects

. Wrote work instructions and procedures to conform with ISO9000

. Corresponded with vendors for information regarding raw materials

. Performed product inspections and improvement initiatives

STRENGTHS

. Written and oral communication

. Word, Excel, and PowerPoint

. Time Management

. Supervising and Personnel Development

. cGMP Requirements

. ISO 9001:2008 Standard

EDUCATION

University of Southern Indiana Evansville, IN

B.S. Accounting, 2002

PROFESSIONAL GROUPS/NETWORKING

. ANEW-A Network of Evansville Women-Member

. Tristate Women-Member

. RABQSA Certified Assessor

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