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

Saint Louis, Missouri 63128

314-***-**** (home)

314-***-**** (cell)

abnecp@r.postjobfree.com

Lawrence M. Mattson

Summary

An experienced quality manager with a proven track record resulting in continuous improvements of quality systems. A

team leader with excellent communication skills and accomplished in networking with multi-functional groups. A results

oriented technical expert successful using statistical data to solve complex problems.

PROFESSIONAL EXPERIENCE

Director of Applied Sciences/Global Community Partnership Coordinator

1/2009-Present

Saint Mary’s High School, Saint Louis, Missouri

Direct the operation and expansion of The Center for Applied Science and associated curriculum, coordinate efforts to

integrate classroom and real-world learning organized around multiple sectors of industry. Participate on Advancement

Team to assist in developing corporate and civic relationships, project funding, and enrollment sustainability and growth.

Lead campus education on environmental issues and best practices, and initiate energy reduction projects

Quality Control Manager Technical Services 10/2003-11/2008

KV Pharmaceutical, Saint Louis, Missouri

Manage the Technical Services group including two supervisors; responsible for managing QC laboratory support

services; calibration, metrology, and training. Oversee the R&D raw material development of methods and specifications.

Major Accomplishments:

Over a 4 year period managed a $500K annual equipment budget including oversight of purchasing, installation, and

validation of over 65 instruments.

Recommended the addition of several complex auto-analysis systems costing over $1M to perform high speed

repetitive assays. The implementation of these systems improved sample turnaround by 50% and saved the company

$325K/year by increasing inventory turns and reducing FTE.

Analyzed SPC product data to determine root cause of product failure resulting in manufacturing changes to insure

reliability of future batches.

Managed the QC laboratory move from a 20,000 sq/ft facility to a state of the art 80,000 sq/ft lab. This was done

while maintaining sample testing with minimal disruption to production schedules.

Participated in FDA audits for general and pre-approval inspections. None of these audits found negative

observations in the technical services areas.

Worked on a Six-Sigma team to reduce process waste saving the company $20K/batch.

Other duties include statistical evaluation of product/process control data for support of continuous improvement

initiative.

Provide review and approval for all process validations as well as manage the testing of samples and summary of data

reporting.

Manage the technology transfer of methods, equipment, and review and approve all documents for QC department.

Department liaison with Project Management, R&D, Operations, Materials Management, & Regulatory Affairs,

regarding technical issues, raw materials, new product launch, and ANDA submissions.

Develop the annual department capital budget by providing technical and cost justifications for new equipment

purchases. Provide technical assistance to troubleshoot problems with procedures, equipment, and training.

Quality Assurance Manager, Strategic Sourcing Group 10/2001-10/2003

Tyco/Mallinckrodt, Earth City, Missouri

Direct all aspects of quality assurance operations to support Strategic Sourcing (Purchase /Resale) product lines. Personal

job assignments include hosting on-site customer audits, FDA audits, performing audits of vendors, and internal audits.

Major Accomplishments:

Developed a supplier risk assessment matrix system and auditing protocols for over 200 suppliers generating

upwards of 350 SKUs.

Performed supplier approval audits for over 15 suppliers each year as well as hosting an average of three customer

audits a month.

Personally handled all customer complaints and worked through solutions resolving over 50 inquiries annually.

Other duties include drafting upper level quality policy documents, approval of all quality documents for QA/QC

& Manufacturing/Packaging, interface with business manager, purchasing, logistics, R&D, customer service, sales,

regulatory affairs, customers, and vendors. Responsible for five QA associates whose daily operations include

labeling, product release, returned goods, Quality document maintenance, customer inquiries, master processes &

validation, product review, vendor approvals, drug listing & registration, DMF reporting, and GMP training. Attended

FDA training on Q7A in 2002.

Group Leader, Raw Materials, Quality Unit 9/2000-10/2001

Mallinckrodt, Saint Louis Missouri

Responsible for managing the QU raw materials testing group.

Participated on vendor approval & reduced testing team resulting in reducing sample loads by 25% and increasing

release times by 40%.

Duties include general employee supervision, providing technical laboratory expertise, performing OOS laboratory

investigations, training, and creation/revision of SOP’s/methods. Serve as quality liaison to coordinate efforts with

receiving, purchasing, scheduling, R&D, and manufacturing.

Quality Control Supervisor 3/2000-9/2000

Forest Pharmaceuticals Inc, Saint Louis Missouri

Managing all aspects of the QC laboratory operations for support of plant production, product stability programs, and

intra-corporation testing services. Participation on corporate committee's: QA/QC conference, USP/PF review

committee, Out of Specification SOP review, Stability SOP review.

Associate Director of Chemistry 1996- 2000

Celsis Laboratory Group (Formally Scientific Associates, Inc.) Saint Louis, Missouri

Managed laboratory operations for the chemistry department. Focusing efforts on technical and administrative issues.

Spearheaded several NDA client projects requiring method development, validation, QC release testing, and stability

support resulting in the approvals of three NDAs. Participated in weekly company management meetings. Involved

with client, FDA, and internal cGMP audits.

Assistant Chief Chemist 1993-1996

Scientific Associates, Inc., Saint Louis, Missouri

Managed operations for the stability laboratory. Worked with upper management and clients to develop stability

protocols, quotes, and methods. Provided technical expertise and training to analytical group.

Analytical Chemist, Scientific Associates, Inc. 1982-1993

Scientific Associates, Inc., Saint Louis, Missouri

Performed cGMP pharmaceutical analysis (USP, EP, BP, etc.) using primarily HPLC and GC. Developed and

validated numerous chromatography methods. Trained staff chemists in GC/HPLC operations.

EDUCATION

Masters in Business Administration

Webster University, Saint Louis, MO

Bachelor of Arts- Science/Chemistry

Webster University, Saint Louis, MO

Six Sigma Green Belt Certification

EXPERTISE IN QUALITY TOOLS

Analytical Program Solving

Six Sigma Green Belt

OOS Investigation

Validation

CAPA

SPC

Risk Management

Supplier Auditing

Technology Transfer

Designed Experiments (D.O.E)

Annual Product Reviews

Quality Data Management Software

Presentations

Presented to ASQ St. Louis Chapter 12/2007, “Quality in the Pharmaceutical Industry”

Seminars, Courses, Workshops

Quality Management Course (MBA elective)

Quality Systems Validation One Week Seminar, 2004, San Diego, CA

SQL-LIMS – One Week Training, 2003 San Jose, CA

FDA – Q7A Workshop 2002, Chicago, IL

Lean Manufacturing Workshop – 2002, Boston, MA

FDA – OOS Investigation Workshop, 2000, Philadelphia, PA

Trackwise Software Training Webinar

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