Quality Manager

Quality Control / GMP / R&D

Regulatory Compliance /

New Process, Product, Analytical Method

Development

Customer & Vendor Relations

Specialty Materials Handling

Corrective & Preventive Actions

I was a Laboratory Manager for highly-regulated

chemical manufacturing facilities. I am adept

at developing and improving processes in

testing, manufacturing and packaging, ensuring

specifications are met accurately and on time.

My focus on quality assurance and regulatory

compliance assures that laboratory functions

efficiently produce superior products.

As a hands-on manager, I am involved in all

aspects of laboratory operations, my

professional strengths include:

- Monitoring and maintaining adherence to

regulatory standards with EPA, FDA, OSHA and

other agencies

- Improving processes and products, meeting

customer specifications and expectations

- Managing lab operations - instrumentation,

manufacturing processes, packaging and waste

treatment

- Conducting quality assurance testing and

rectifying deficiencies in raw materials,

process or packaging

I hold a Ph.D. in Organic-Polymer Chemistry

and Master's Degree from Oklahoma State

University and a BA from Gordon College. I am

a member of the American Chemical Society and

the American Society for Quality. I am known

as a team player with a friendly, positive

attitude and a creative approach to problem

solving. I am trilingual and well-traveled.

CAREER HISTORY

Pall Corporation, 2007 to 2010. A $2.5B

manufacturer specializing in filter media and

membrane technology.

- Senior Project Leader. 2008 to 2010.

Investigated and analyzed customer concerns,

applying Corrective And Preventive Actions

(CAPA). Managed vendor relations with

materials suppliers. Monitored raw materials

and testing processes for regulatory

compliance. Provided technical support to

manufacturing, engineering R&D and

laboratories.

- Analytical Laboratory Manager. 2007 to 2008.

Supervised all analytical lab operations,

including instrument qualification,

calibration and preventive maintenance.

Utilized quality assurance resources in

testing raw materials, assaying, delivery of

finished product and handling expired

chemicals. Managed three employees and $500K

budget.

Elf-Ato Chem. N.A. / Ozark-Fluorine Specialties,

Inc. 1994 to 2007. A producer of specialty

fluorine chemicals.

- Analytical Laboratory Manager. 2000 to 2007.

Organized and supervised all lab operations.

Ensured expedited assay results and QA

processes. Managed materials testing and

packaging guidelines. Instituted stability

studies according to FDA regulations. Oversaw

FDA, EPA and OSHA audits. Managed $200K budget

and three employees.

- Chemist. 1994 to 2000. Manufactured chemical

products and packaged appropriately. Conducted

qualitative and quantitative chemical

analysis. Implemented United Stated

Pharmacopeias analytical methods of testing.

Developed new processes and improved existing

processes. Supported manufacturing department

with special projects.

Accomplishments

Turned Around Lab Operations, Eliminating

Regulatory Citations.

Ozark-Fluorine Specialties Inc. underwent FDA

audit, receiving 41 citations. Analyzed and

improved all areas of laboratory processes,

including manufacturing, sampling, shipping,

documentation, procedures and training of staff.

Reduced citations to two and then none in

subsequent audits.

Conducted Laboratory Testing of New

Materials, Improving Customer Satisfaction.

Compound produced by Ozark-Fluorine Specialties Inc.

experienced low yield, with one of five batches

lost and excessive side waste. Changed raw

materials, tested samples and presented results

to CEO. Realized significant cost savings with

no lost batches or waste.

Applied Corrective and Preventive Actions,

Resulting in Process Improvements.

Pall Corporation moved their packaging and

shipping operations to Tijuana, Mexico.

Numerous customer complaints arose from

products received incorrectly packaged.

Analyzed and educated off site staff, reducing

errors and delivering quality products to customers.

Modified Product, Meeting Customer

Specifications To Promote Rapid Growth.

Potential customer needed quality improvements

and greater quantity of resin produced

by Ozark-Fluorine Specialties Inc. Investigated

purpose of product for client and developed

modified process to meet specifications.

Met customer demand, increasing orders 1200%.

Earlier: Consultant Massco Dental Company,

Research Associate, Dept. of Entomology,

Oklahoma State University.

Additional Activities: I enjoy volunteering

activities, such as setting up high school

chemistry labs and judging science fairs. I

teach online classes part-time for Columbia

Southern University and enjoy spending time

with my family.

Contact this candidate