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NNEOMA. C. ONUKWUE

White Plains, New York ****3

914-***-****; 914-***-**** Email: acw2dw@r.postjobfree.com Results–oriented professional with extensive experience in Quality Assurance/Control and Compliance in pharmaceutical and healthcare industries. Strong analytical skills which enable learning new concepts and processes easily. A highly dependable professional with a strong technical background, effective communication skills, proactive and preventative mindset that results in the ability to maintain an excellent record in safety and compliance. Strong experience in safety/cGMP/GLP training and auditing. Known for consistently completing projects ahead of schedule.

HPLC/UPLC/ChemStation

cGMP/GLP/FDA

GC/UV/FTIR/TLC

Karl Fischer/Melting

Point/Dissolutions

Process/Cleaning

Validation

Total Chrom/Empower/

SAP/Q-DIS/DISOL

Auditing/Training

Non-Conformance

Reports/Investigations

Microsoft Office/ Project

PROFESSIONAL EXPERIENCE

Mercy College Adjunct Professor White Plains/Dobbs Ferry, N.Y. 2007- Present

Develop classroom curriculum.

Grade homework assignments and examinations.

Track students’ attendance and progress in class.

Develop academic performance reports on students

Known for motivating students to achieve high goals with patience & perseverance.

Experience with students of different learning abilities.

Strong problem solving & project management abilities.

Excellent organizational, communication & interpersonal skills. Novartis Pharmaceuticals Corp. Suffern, N.Y. 2006 - 2015 Billion-dollar Pharmaceutical Corporation focusing on development and manufacturing of medications for better Health management.

Senior Scientist Quality Control (Started as Scientist) Provided quality control review of all testing solid dosage forms prior to market release.

Performed cGMP quality control review of Research and Development method development and method validation summary reports

Generated and reviewed investigation reports, root cause analysis, preventative and corrective action (CAPA) reports (OOS data / records)

Reviewed In-process batch records, Certificate of Analysis and finished product final release for dispatch in SAP system.

2

Exceptional multi-tasking & project planning abilities.

Strong problem solving and trouble-shooting/technical skills.

Key contributor to new Product launches and Process Validations

Instrumental Analysis of Finished & Stability Products.

Coordinator of the Department’s Annual Peer Reviews.

Safety and cGMP/GLP Trainer/Auditor.

Consistently received internal recognition for Product Quality, zero accidents and exceptional documentations.

Tracked and filed documentation /training records of other analysts.

Strong knowledge of cGMP, GLP, QC & manufacturing processes

Achieved 9 years of service without a lost time injury. Nice Pak Products Inc. (Healthcare Division). Orangeburg, N.Y. 2002 - 2005 A World Leading Healthcare industry focusing on Consumer and healthcare hospital grade finished products

QC Scientist/Team Leader

Conducted analysis on Stability, Finished Products, and Raw materials for releases to Production Department.

Trained and supervised new analysts and reviewed their documentations as per SOP, USP

Formulated & Adjusted Production/Manufacturing Liquid Batches.

Successfully re-designed the Internal Laboratory and Documentation Auditing Procedures.

Actively participated/assisted Manager & Director in FDA/EPA/OSHA inspections.

Identified new compound solution to meet customer requirements by developing and testing various formulations of product.

Generated, reviewed and filed OOS/investigation reports.

Successfully changed the process of reviewing Certificate of Analysis (CoA) before releasing raw materials to the Production Department.

Strong leadership/management skills.

Par Pharmaceutical Inc. Spring Valley, N.Y. 2000 - 2002 A Generic Pharmaceutical Company

Quality Control Chemist

Contributed to successful on-site inspections by Regulatory Agencies.

Consistently performed analytical tests on raw materials using classical wet chemistry and instrumental techniques.

Outstanding document control and filings.

Trained, reviewed and validated analysts’ written documentations as per GLP, SOP & USP regulations.

EDUCATION

Long Island University, Brooklyn, N.Y.

MS in Industrial Pharmacy 2005

BS in Chemistry 1999

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