Manager Quality Control

Lyle Boehland

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

Apple Valley, MN 55124

abif01@r.postjobfree.com

952-***-**** (Home)

612-***-**** (Cell)

WORK EXPERIENCE

Consultant Boston Scientific

Maple Grove, MN

April 2008 - Present

Consultant to LSR (Legacy Software Remediation) teams to perform software

and software equipment Assessment, ERES Assessment, Validation and

Retirement.

Consultant Boston Scientific

Maple Grove, MN

March 2006 - June 2006

Consultant to review and approve validation documentation for computerized

systems in the Medical Device Manufacturing facility. Validation

consultant for facilities, including building automation system (BAS).

Documentation included Risk Assessment, URS, DS, Traceability Matrix, IQ,

OQ and PQ.

Consultant Pfizer Research & Development

Saint Louis, MO

November 2004 - October 2005

Consultant to Research and Development Laboratory to perform 21 CFR Part 11

assessment and remediation of computer systems. Risk Assessment,

Compliance Assessment and Compliance Action Plans for GMP systems.

Retrospective writing and execution of validation documents (URS,IQ,OQ,PQ)

for high

risk computer systems.

Consultant Pfizer Global Manufacturing

Holland, MI

May 2002 - June 2004

Laboratory consultant to author 21 CFR Part 11 assessments of all critical

computerized systems remediation plans and validation (Vendor Audits, URS,

FRS, Traceability Matrix, IQ, OQ, PQ, Final Report) for existing and

replacement laboratory computer systems for electronic record and signature

compliance.

Consultant Pfizer Pharmaceutical

Ann Arbor, MI

October 2001- December 2001

Member of a consulting team to prepare 21 CFR Part 11 assessments of

computer systems located at the Research & Development laboratories, for

electronic record and signature compliance. EDMS used for the project was

Documentum.

Consultant Warner-Lambert Pharmaceutical

Parsippany,NJ

June 1998-June 2000

Validation on World-Wide Beckman LIMS rollout team. Development, Change

Control of System, Documentation, Acceptance Testing and Installation

Verification. Validation Protocol Execution of Beckman LIMS and

Chromatography Data System installed in Parsippany NJ, Morris Plains NJ,

Lititz PA, Holland M, Fajardo PR, Cork Ireland and Freiburg Germany..

System was Beckman CS 8.4a with Oracle database, using HP9000 server with

UNIX operating system.

Consultant Bristol-Myers Pharmaceutical

Wayne, NJ

November 1996-September 1997

Wrote Performance Qualification Validation tests, designed and modified

screens and reports for Beckman Laboratory Information Management System

installed in Morrisville, North Carolina. System was Beckman CS 8.3, with

Oracle database, using HP9000 server with UNIX operating system.

LIMS Manager Koch Refining Company Oil Refinery

Pine Bend, MN

July 1990-November 1996

Proposed, specified, and installed Beckman LIMS, Version 7.0 on VAX 3900.

Updated Beckman LIMS system to Version 7.4. Beckman LIMS Manager.

Supervision of Chemist laboratory. Supervision of gas chromatography lab,

Laboratory Project Manager, Laboratory Account Manager.

Chemist Koch Refining Company Oil Refinery

Pine Bend, MN

July 1977-July 1989

Supervision of control laboratory with 23 laboratory employees. Proposed,

specified, and installed Fison VG MULTICHROM gas chromatography data system

(System Manager). Proposed, installed, and developed methods for Perkin-

Elmer AA, Hewlett-Packard simulated distillation and capillary GC's,

Precision Scientific ADA's and Metrohm titration system. Worked with

computer team to specify, code, install and operate custom COBOL laboratory

computer data system.

Laboratory Manager Ashland Petroleum Company

Oil Refinery

Tonawanda, NY

July 1974-July 1977

Coordinate quality control laboratory activities with research, sales, and

production. Supervision of 18 laboratory employees. Wrote laboratory

testing methods manual. Supervision of Synthetic Natural Gas plant on line

testing.

Laboratory Supervisor Ashland Petroleum Company

Oil Refinery

Canton, OH

July 1968-July 1974

Supervision of 11 employees in quality control program. Set up wastewater

testing laboratory. Updated laboratory testing equipment and procedures.

Control Chemist Ashland Chemical Company

Central QC Lab

Minneapolis, MN

July 1967-July 1968

Testing of plastics, resins and industrial chemicals for specification

compliance. Test procedure development.

EDUCATION

College: Bemidji State College, Bemidji, MN

Major: Chemistry

Minor: Biology

Degree: Bachelor of Science in Education

High School: Bertha-Hewitt High School, Bertha, MN

Other:

cGMP Training

21 CFR Part 11 Training

Validation Guideline Training

Acceptance Testing Training

Beckman LIMS User Training

Beckman CALS Lab Mgr. Training

Beckman LIMS System Manager Training

Coaching Training

Microsoft Excel, Word, Access, PowerPoint

Fison GC-MS Training

Fison XRF Training

Perkin-Elmer TGA Training

Digital Utilities and Commands

Dale Carnegie

H-P Gas Chromatography Training

Waukesha CFR Engine School

Ethyl ASTM Engine Operation and Maintenance

U of M Mankato WP, DB, SS

U of M Pascal Computer Programming

St. Paul AVTI Non Destructive Testing I

St. Paul AVTI Non Destructive Testing II

St. Paul AVTI Chromatography Series

Dakota AVTI BASIC

EPA U of Tulsa Biological Treatment

U of NY, Buffalo COBOL Fundamentals

U of NY, Buffalo FORTRAN

US EPA Pollution Control Assessment

ASQC Quality Motivation

ASQC Basic Quality Control

ASQC Effective Industrial Communications

ASQC Sampling Plans

ASQC Intermediate Quality Control

ASQC Experimental Design and AOV

ASQC Managing a Total Quality Control Program

CITATION

Akron-Canton Section, American Society for Quality Control,

Professional Citation for Quality

Management

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