Souzi Bateh

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

770-***-**** (Home)

Kennesaw, GA 30152 abqzl2@r.postjobfree.com

678-***-**** (Cell)

Professional Summary:

o Accomplished Analytical Chemist and Microbiologist.

o Successful Project leader and team member.

o Quality oriented and organizational team skills.

o Familiar with 21CFR (Part 11, Part 820, Part 211), ISO 9000, ISO 13485,

ISO 17025, ISO 14644, ISO 14698, OSHA and DEA regulations.

o Aseptic techniques in clean room environment (Class 5, 7 and 8)

o CAPA, nonconformance resolution, change control, root cause

investigations.

o Validations: Method, Mixing, Process, Cleaning

o Japanese language for business.

Technical Experience:

Instrumentation: GC/Headspace, HPLC, FTIR, UV-VIS, TOC, AA, Karl

Fisher, Polarimeter,

Dissolution Apparatus, Flow Cytometer,

Luminometer, BacT

Computer skills: Microsoft Office, Lotus Notes, ROSS ERP, Empower and

Chemstation.

Professional Experience:

Aderans Research Institute, Marietta, GA

2011- Present

Quality Assurance/Control (Phase II Clinical)

> Project manager responsible for establishing a Quality Control

Chemistry program for Phase III Clinical.

> Project Lead on the characterization and GMP manufacture of a

proprietary component and raw materials.

> Project Lead on analytical test method development, validation,

transfer and personnel qualification.

> CAPA team leader for nonconformance resolution.

> Team member of several validation teams to include cleaning and mixing

validations.

> Review and approval of Master Batch Records, product labels and test

documents.

> Compose and revise Material Specifications documents, SOPs, and

protocols and training of personnel.

> Inspection, approval and testing of incoming raw materials according

to ANSI/ASQZ1.4.

> Environmental monitoring of sterile facility and cell process.

> Sterility, endotoxin, and cell count testing of raw materials, in-

process and finished products in clean room.

> Meet with vendors on and off site to discuss materials and business

goals.

Mikart, Inc, Atlanta, GA

2008- 2011

Senior Analytical Chemist

> Project lead for the completion of method validations for cleaning

validations and verifications per Mikart protocols using the TOC

Analyzer.

> Perform routine equipment maintenance and calibrations and coordinate

service calls.

> Proficient in the analysis of raw materials, in-process, final and

stability products on solid and liquid dose pharmaceuticals according

to USP and Mikart protocols using both wet and instrumental methods.

> Expedited the analysis of product complaint samples.

> Executed laboratory notebook audits in collaboration with the

Regulatory Affairs Dept.

> Performed inventory and documentation for the destruction of

controlled drugs according to DEA regulations.

> Conducted chemical inventory and disposal according to OSHA

regulations.

> Training of new personnel.

> Interacted with customers and vendors.

Microbiologist II

> Execution of microbiological testing of water, raw materials, finished

product, cleaning validation verification.

> Evaluation of environmental monitoring data which includes organism

identification.

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Souzi Bateh

3431 Owens Landing Drive

770-***-**** (Home)

Kennesaw, GA 30152 abqzl2@r.postjobfree.com

678-***-**** (Cell)

Professional Experience:

Abbott Laboratories, North Chicago, IL

1993 -1997

Senior Analytical Chemist

> Accomplished validations of analytical methods, verification of lab

data and training of new personnel.

> Performed installation of data acquisition instrumentation, training

of personnel and worked with vendor management for problem

determination and resolution.

> Skilled in the analysis of final and stability products which included

large to small volume parenterals according to Abbott standards using

both wet and instrumental methods.

> Promptly scheduled stability testing on all products according to

regulations.

> Expedited the analysis of product complaint samples.

> Coordinated monthly lab safety audits and ordered chemicals and

supplies when needed.

Pennex, Inc, Morton Grove, IL

1992 - 1993

Analytical Chemist

> Developed and validated analytical methods on new drug products and

training of personnel.

> Accomplished the analysis of raw material, in-process, final and

stability products according to USP protocols using both wet and

instrumental methods.

> Conducted inventories of supplies and chemicals and placed orders.

Additional Experience:

Cobb County Schools, Kennesaw, GA

2007- 2008

Substitute Teacher

> Served in the capacity of a teacher in their absence at all grade

levels.

Steven R. Bateh, D.M.D. Dental, Green Cove Springs, FL

1997- 2003

Front Office Manager

> Responsibilities included corresponding with managed health care in

regards to customer accounts, setting up appointments, customer follow

up and setting up daily schedules.

Sears Roebuck & Co 1987-

1997

Customer Service Representative (part-time)

> Responsibilities included customer inquiries, returns, exchanges and

new accounts.

> Balancing the entire store accounts and cashiers at close of business.

Education: Loyola University of Chicago, BS in Chemistry, May 1992

Research Assistant 1990-1992

> Worked on the synthesis of a reagent to cross link with hemoglobin to

product blood substitutes.

References: Furnished upon request.

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