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Location:
Arlington, TX, 76016
Salary:
$84,000
Posted:
September 11, 2008

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Resume:

Michele K. MOORE uz4n5y@r.postjobfree.com

**** ********* ***** 817-***-****

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

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&D units; 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&D personnel; 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&D units; 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&D personnel

1994-2000 Quality Assurance Unit Auditor II - Performed GMP/GLP Quality System Audits; 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.



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