Project Manager Customer Service
Resume:
Souzi Bateh
770-***-**** (Home)
Kennesaw, GA 30152 ********@*****.***
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 ********@*****.***
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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