January, 2010.

Nneoma Onukwue
129 Maryton Road
White Plains, N.Y. 10603
Phone: 914-482-1452
E-mail: nonukwue@yahoo.com

Dear Sir,

I have enclosed my resume to provide a summary of my qualifications and

background for your review. I seek to advance my professional career in a
challenging operational Senior Management setting, where proven
competencies in quality responsibilities will be valued and well utilized. I
prefer to affiliate with a company that is positioned to expand and prosper.

Through this letter and resume, I wish to become an active candidate for
employment with your organization. I am comfortable in Quality Assurance,
Quality Control, Compliance and Research. My primary emphasis has
always been placed on creating and maintaining the highest standards
needed to satisfy clients and patients with regard to excellent health.

My goal is to affiliate with a company dedicated to professional excellence,

competitive positioning, and total quality management. I will bring a
successful track record in management, well-directed initiative, and a firm
commitment to success. In this setting, I would very rapidly become a
significant factor in the long-term success of an organization such as yours.

In the belief that the combination of my skills and experience would prove to
be an asset to your executive team, I am hopeful you will grant me a
personal interview. In the interim, I thank you for your time and
consideration. I look forward to meeting with you soon.

Yours truly,
Nneoma Onukwue.
 NNEOMA .C. ONUKWUE
129 Maryton Road, White Plains, N.Y.10603.
Phone: 914-482-1452 E-mail: nonukwue@yahoo.com
______________________________________________________________________

OBJECTIVE
To obtain a quality management position in the field of Biotechnology, Biopharmaceutics
or Pharmaceutics, where my academic credentials, skills and expertise can be utilized to
the growth and success of your organization.

QUALIFICATIONS
• Experience working in Analytical / Research & Development Labs.
• Expertise in writing, reviewing & approving lab procedures / documentations, OOS
reports, batch records, protocols, etc.
• Expertise in auditing as per FDA, ISO 9000, EPA, OSHA regulations &
specifications.
• Strongly skilled in analytical instrumentation such as FTIR, UV-Spectrophotometer,
GC, HPLC(Totalchrom / Turbochrom / Chemstation, Empower, QDIS), Karl Fischer,
DISSOLUTION,
• Strongly skilled in cGMP / SOP Trainings.
• Expertise in liaising, coordinating inspections with regulatory agencies (FDA, EPA,
ISO 9000)
• Knowledge of Microsoft Office
• Knowledge of Method Development / Transfer / Validation (Linearity, Accuracy,
Precision, etc)
• Excellent communication skills, tolerant and patient with people.
• Goal Oriented and Results Driven Team Leader.

EXPERIENCE

Novartis Pharmaceuticals Corp. Jan. 2006 - Present

Senior Scientist
• Analyze Solid dosage forms as per SOP/ USP using Instruments
(Dissolution, Content Uniformity, Assay, Impurities, etc)
• Validator of Test Results & Laboratory Auditor (QA, QC, Audits).
• Tracking & Filing Batch / Documentation Records
• Genarate & Review OOS data / records
• Review Analysis reports and Certificate of Analysis (COA)
• Maintain & Observe cGMPs, cGLPs.
• Attend Departmental meetings
Nice Pak Products Inc. (Healthcare Division)
QA / QC Scientist & Team Leader Oct. 2002- Dec. 2005
• Conducted analysis on Stability, Finished Products, and Raw materials for
releases.
• Analyzed sample batches for Production Dept. using instrumental techniques
(HPLC, UV-Vis, FTIR, GC, Auto-titrator, TOC, etc) as per monographs, USP, etc.
• Maintained & observed cGMPs, cGLPs and safety.
• Reviewed Certificate of Analysis and Analysis reports.
• Trained & supervised new analysts and reviewed their documentations as per
SOP, USP.
• Represented QA Manager during FDA / OSHA inspections.
• Assisted QA Manager and Director.
• Internal Laboratory & documentation Auditor.
• Wrote reports of Audit Observations.
• Generated, reviewed & filed OOS / investigation reports
• Assisted R&D Dept. in Method Development and transfer.
• Reported departmental activities to Director and Executive Management board
• Attended departmental and Executive Board meetings.

Par Pharmaceutical Inc. May 2000 – Oct. 2002

Quality Control Chemist
• Performed analysis on raw material samples using classical wet chemistry and
instrumental techniques (HPLC, GC, FTIR, UV-VIS, Potentiometer, Manual
titration, Sonic, Air-jet, Malvern & Ro-Tap sieve analysis, Bulk & Tapped density,
Karl Fischer, wet chemistry methods, packaging components, etc.)
• Maintained & observed cGMPs, cGLPs and safety.
• Assisted Manager & Group leader with raw material document control, filing, etc.
• Trained new Analysts as per SOP and USP.
• Reviewed analysts’ notebooks.

EDUCATION
Long Island University, Brooklyn, NY.
MS in Industrial Pharmacy, May 2005

BS in Chemistry, May 1999