Michele K. MOORE 
5623 Waterview Drive  [Send email to request phone number] 46-3676/ [Send email to request phone number] 21-2018
Arlington, TX 76016
~ Specializing in Quality Assurance/Control in the Biotechnical/Pharmaceutical
Industry ~
Audit Expertise
* GMP/Quality Audits of Large Volume/Small Volume/Flexible Containers
Facilities/Development Departments (Process/Formulation Devlepment)
* GLP/GCP/ISO/MDD/Quality System Audits of R&D Labs/Departments
Review of:
* Research and Development Laboratory Raw Data and Documentation
* Regulated/Nonregulated Study Protocols
* Technical Reports
* Government Submissions
* Stability Data
* Vendor/Supplier Evaluations
* Standard and Technical Procedures -Quality System/Unit
* Biostatistical Reports
* Computer Validation Plans
* Material Specifications
* Labelling Batch Records
Computer Expertise
* Outlook /Word/Excel/Powerpoint/Access/Cats Web/OmniRim/Nikita/LIMS

Education

1983 BACHELOR OF SCIENCE, Magna Cum Laude North Carolina Wesleyan College
 Biology Rocky Mount, North Carolina

Volunteer Experience
Dec 07 to May 09: Martin High School Arlington, TX (aided w/school trips, Senior
activities)
Jan 08 to June 09: Fielder Baptist Church Arlington, TX (aided in fund raising,
church activities)

Professional Experience

* ALCON LABORATORIES Fort Worth, Texas
2006-2007 Quality Assurance Unit Senior Auditor II - Performed
GMP/GLP/ISO/Quality System Audits of all R Began auditing Clinical/Regulated
Data/Reports; Reviewed Stability and all Nonclinical Data/Reports; Became PRO of
Quality System procedures for Laboratory Chemicals; Reviewed all Standard
Operating Procedures and Technical Reports, Became PRO of Quality System
Procedure on Technical Reports, Assisted in training of GLP/Quality System
requrements for all new R Assisted in creating all internal audit checklists
2000-2006 Quality Assurance Unit Senior Auditor I -Performed GMP/GLP/ISO/Quality
System Audits of all R Reviewed Stability and all Nonclinical Data/Reports,
became PRO of Quality System Procedures for Laboratory Chemicals; Reviewed all
Standard Operating Procedures and Technical Reports; Became PRO of Unit
Procedures; Assisted in training of GLP/Quality System requrements for all new R
Reviewed stability data; Assisted in writing standard operating procedures

* ABBOTT LABORATORIES Rocky Mount, North Carolina
1992-1994 Quality Assurance Technical Services Specialist - Peformed GMP audits;
Maintained the plant's Pest Control program, assisted in writing/reviewing plant
basic operating procedures.
1989-1992 Biology Laboratory Technician II - Did biological lab testing of the
entire plant - including clean suites within the Manufaturing areas. Peformed
swab, water, and air sampling.
1984-1989 Biology Laboratory Technician I - Did biological lab testing of the
entire plant - including clean suites within the Manufaturing areas. Peformed
swab, water, and air sampling.

Professional References
Adryce Mathisen Alcon Labs  [Send email to request phone number] 51-6945
Ramon Espino/Alcon Labs  [Send email to request phone number] 51-6945
Beth Blanchard/Abbott Labs 252-977-5111