Quality Assurance Control

CHARLES ANDOH

*** ************ **, *** *******, NY 10958

845-***-****-Home; 845-***-**** - Cell; ******@*****.***

EXPERIENCE SUMMARY

Ten years of experience as a validation specialist, QA/QC chemist and auditor.

PROFESSIONAL EXPERIENCE

Sr QA Validation Specialist/Manager November 2006 – Present

Wyeth Pearl River, NY

• Quality Review of Media Simulation and Process Validation Reports for Commercial

Production Batches.

• Qualification/Validation Deliverables in support of the Fill/Finish PPU, Formulations

PPU and Polysaccharide PPU.

• Supervision/management of three junior specialists.

Sr. Validation Specialist /Validation Specialist September 2001 – November 2006

Hitachi America, Ltd./Validation Masters, Inc. Assigned to Wyeth, NY and Imclone, NJ

• Development and execution of IQ/OQ/PQ protocols for bioreactors, autoclaves and

depyrogenation ovens (sterilization chambers), filtered air/nitrogen/oxygen/carbon dioxide and

WFI utility systems, process and cleaning validation, laboratory equipment, scales, mixing plates,

water baths, centrifuges, incubators, chill rooms, sonicators, glassware washer, refrigerators,

LN2/cryogenic freezers, environmental monitoring, and biosafety cabinets.

• Extensive experience in Sterility Assurance and lethality studies(using moist and dry

heat).

• Validation of Media Simulation in Production Bioreactor Systems.

• Extensive use of the Kaye Validator 2000 temperature mapping system.

• Development of Validation Master Plans and Gap Analysis.

• Managing execution and deliverables schedules to ensure project is completed on time.

• Quality Review of Qualification/Validation Protocols and Reports.

• Investigating deviations and preparing deviation resolution reports.

Training and Reviewing work of validation specialists.

Validation Specialist January 2001-September 2001

WGI, Consulting Assigned to Merck & Co., Rahway, NJ

• Development and execution of (IQ/OQ/PQ) Protocols for manufacturing

equipment(fermentors, bioreactors and centrifuges) and cleaning validation processes.

• Temperature mapping experience with the Kaye Validator 2000.

• Execution of Cleaning and Recovery Studies. Auditing Laboratory Reports and

documentation.

Contract Scientist, Analytical R & D Dept. January 2000 - January 2001

Wyeth-Ayerst Research Pearl River, NY

• Responsible for development and execution of Installation and Operation Qualification

(IQ/OQ) Protocols for all analytical equipment such as HPLC, GC, LC-MS, Dissolution, Mass

Spectrometers and Densitometers.

• Responsible for Calibration of all Dissolution Systems within the Analytical Research and

Development department.

Quality Assurance/Quality Control (QA/QC) Chemist April 1999 - September 1999

Bristol-Myers Squibb (Clairol) Stamford, CT

Testing and releasing chemical raw materials and finished products using LIMS and SAP in

GLP/cGMP environments. Used HPLC, GC, UV-VIS, FT-IR, and TLC regularly as part of the

laboratory equipment in products analyses. Experience with Autotitrators and Wet chemistry.

Charles Andoh Page 2 of 2

Chemical Raw Material Technician and QA Associate June 1998 – April 1999

Alvin Last, Inc Ardsley, NY

Responsibilities included testing and releasing chemical raw materials in GLP/cGMP environments.

Managed chemical inventory using Macola program. Wrote Standard Operating Procedures (SOPs).

Answered all questions regarding MSDS and Certificate of Analyses (C of A’s) for our products.

Environmental Chemistry Lab Assistant-Environmental Task Force Fall 1996 – May 1998

(ETF) Lab., UW-SP Environmental Science Dept Stevens Point, WI

Responsibilities included testing and releasing water samples in GLP/GMP environments, and

communicating the results to laboratory operators and home owners.

Analytical Chemistry Lab Assistant Fall 1995 – Spring 1998

University of Wisconsin-Stevens Point Stevens Point, WI

Worked on Separation of Protein; alpha, beta and gamma crystallins using Capillary Electrophoresis

(CE) and Isoelectric Focusing (IEF).

SPECIAL SKILLS:

• Effective oral and written communication skills.

• Experienced with the use of HPLC, NMR, GC, LC-MS, IR and UV-VIS.

• Strong public speaking ability.

• Excellent organizational skills and a well developed leadership ability.

• C++ computer programming ability.

• Proficient in Microsoft Access, Excel, Power Point and Word.

• Excellent interpersonal relationship; team player.

• Project management and supervision experience.

• Training and development.

INSTRUMENTATION:

Proficient in the use of the following equipment:

• Kaye Validator 2000 temperature mapping system

• Scanning Electron Microscopy (SEM), Atomic Absorption (AA)

• HPLC, LC/MS, Gas Chromatography (GC), GC/MS, TLC

• Capillary Electrophoresis (CE)

• Fourier transform infrared spectroscopy (FT-IR), IR, UV-Vis, NMR

• Karl Fischer (Autotitrators), TOC Analyzer

EDUCATION/TRAINING

MBA – August 2001 University of Bridgeport, Bridgeport, CT

BS Chemistry Major, Double Minor in Biology and Water Resources - August 1998,

University of Wisconsin-Stevens Point (UW-SP), WI

PROFESSIONAL AFFILIATIONS:

• American Chemical Society (ACS) 1996-Present

• Medicinal Chemistry Division of (ACS) 1998-Present

References: Would be made available upon request.

Contact this candidate