Quality Control Manager

Christopher P. Culp

*** ***** ***** *****, ***** Springs, NC 27540 919-***-****

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

OBJECTIVE

Process Development Scientist bringing 15+ years of Pharmaceutical

experience and skills in manufacturing processes, mechanical aptitude,

technical problem solving, procedure development, working with suppliers,

continuous improvement, team leadership, statistical data analysis,

training, quality control, and communication.

EXPERIENCE

Manufacturing Manager Wyeth Pharmaceuticals, Sanford NC 2004 - 2008

. Supervised a diverse team of Process Deviation Investigators, Technical

Writers, and Trainers using coaching and leadership that promoted the

production of world class vaccines in compliance with FDA cGMPs.

. Improved manufacturing operation efficiency by implementing measurement

systems for documentation errors that resulted in a >50% reduction of

documentation errors.

. Developed and implemented corrective actions using data analysis and

experience that resulted in the elimination of recurring manufacturing

problems.

. Generated reports and tracked performance metrics using Microsoft Excel

and Word and presented results regularly to senior management.

Operations and Project Specialist, Wyeth Pharmaceuticals, Sanford NC

2001 - 2004

. Managed Wyeth's Sanford site projects and programs designed to strengthen

the company and the Sanford facility.

. Authored Standard Operating Procedures, training materials, and reports

using technical writing skills to meet deadlines and improve regulatory

compliance.

Production Manager, BASF Corporation, Wyandotte, MI 1999 - 2001

. Managed BASF's Vitamin Blends plant with an annual budget of $10 million

producing custom blends of Active Pharmaceutical Ingredients in

compliance with FDA cGMPs.

. Scheduled production, maintenance, and engineering projects using

technical analysis and resourceful planning that maximized capacity and

productivity.

. Maintained production schedule and safe working conditions in spite of

replacing 50% of the manufacturing technicians who were in turn trained

quickly and efficiently.

. Supervised 6 diverse Manufacturing technicians using coaching and

teamwork in a dynamic environment producing over 30 different products.

. Reduced the unusable inventory in the Vitamin Blends plant from >$50,000

to less than $2,000 by working with Quality Assurance to obtain

dispositions and working with Manufacturing Technicians to use material

approved for reprocessing.

Quality Engineer / QC Supervisor, BASF Corporation, Wyandotte, MI 1994 -

1999

. Supervised routine laboratory operations and 3 Quality Control

technicians through coaching and teamwork in a dynamic environment

testing raw materials and finished products that supported the production

of vitamins A, D, and E in compliance with cGMP's.

. Praised by manager as "very creative and innovative - presented with a

problem, he can usually come up with a number of options to try to solve

it or handle it."

. Conducted and assisted with the design and implementation of process

improvement initiatives using team concepts and statistical tools

resulting in decreased QC and QA cycle times.

. Worked on cross-functional teams with Manufacturing and R&D to transfer

new products, new processes, and to improve existing processes.

. Reviewed analytical data for raw materials and finished products based on

USP and other testing methods and approved testing results based on

specifications.

. Re-organized the Vitamins Quality Control technician reporting structure

using innovation and technician input which resulted in increased

empowerment and improved manufacturing support.

. Conducted routine and non-routine laboratory chemical analysis using

HPLC, GC, FTIR, UV/Vis, and other analytical instrumentation that met

testing schedules and cycle time objectives.

EDUCATION

Master of Science in Quality Engineering (all courses completed), Eastern

Michigan University, Ypsilanti, MI

Bachelor of Science in Chemistry, University of Michigan, Dearborn, MI

ACTIVITIES

East Carolina University Engineering Advisory Board

Charity / Non-profit Volunteer

Cycling

World Travel

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