Quality Assurance Control

Usha A. Amin

Cell: 845-***-****

E-mail: kgo3qe@r.postjobfree.com

OBJECTIVE: To obtain a position as a data reviewer utilizing my 25 years of analytical experience, in the departments of Analytical Research and Development, Quality Control, Quality Assurance or Regulatory Compliance.

PROFESSIONAL BACKGROUND

Coldstream Laboratories Inc, Lexington, KY

Chemist II (3/10 to 4/12)

• Reviewed GMP data generated from QC (Quality Control), ARD (Analytical Research & Development) and FD (Formulations Department), including method development, validation, formulations development support, manufacturing in-process testing, product release, stability testing and raw material release.

• All mathematical formulae, calculations using appropriate units checked.

• Gained experience in liquid formulations including suspensions, injections and lyophilized drug products.

• Ensured data for accuracy, integrity, completeness and compliance to ICH, USP, FDA regulatory and internal SOPs.

• Data generated for Phase I, investigational drugs, clinical trials were reviewed with urgency, importance and understanding of these drugs to humans and animals.

• Periodically audited logbooks, test methods, protocols, report of analysis and test specifications.

• Assisted in reviewing, editing, and proofreading technical documents for accuracy and compliance.

• Communicated with laboratory analysts the errors found upon document/data review.

• Completed data review in a timely manner as release, production and clients waited for signed documents.

• Introduction to viscosity, specific gravity, container closure, particulate matter, volume in container data review.

MannKind Corporation, Danbury, CT

Senior Research Associate, (10/2006 to 4/2009)

• Performed assay of In-Process, Finished Product, Stability and research samples from cross-functional departments using HPLC.

• Tested for NDA submission.

• Developed test method for analysis of metals in raw materials by atomic absorption (AA) technique.

• Tested aerodynamic properties of powders by ACI (Anderson Cascade Impactor).

• Performed test method validation activities.

• Reviewed annual instrumentation qualification documents.

• Conducted column equivalency study for HPLC analysis of in-process materials.

• Reviewed data generated by colleagues.

Watson Pharmaceuticals, Inc., Danbury, CT

Analytical Research and Development Operations

Senior Scientist, (9/1997 to 10/2006)

• Project Leader for an ANDA product from receipt of Raw Material to its completion by testing of the Raw Material to Finished Product including writing protocols, communicating with formulators, vendors, auditing data by outside contractors, maintaining appropriate records, attending project meetings and assigning experiments to junior analysts .

• Performed method development and validation in compliance with good laboratory practices, company SOPs and safety regulations.

• Conducted analytical method transfers between sites.

• Performed assay, related compounds, and/or dissolution analysis of raw materials, in-process, finished products, ANDA, and stability samples using HPLC, GC, GC Headspace and/or UV/IR spectrophotometer methods.

• Performed residual solvent and KF (Karl Fischer) analyses of raw materials and finished products.

• Performed validation of cleaning methods for new products.

• Maintained appropriate records of testing: communication problems, results and recommendations to management as required.

• Used and understood appropriate GMP compliant and department approved computer software (Millennium32 ver4.0, Access* Chrom, Microsoft Word, Microsoft Excel and Lotus Notes)

• Standard Coordinator responsible for orders, receipt, safe handling and storage, dispensing, destruction and maintenance of the in-house standard program.

• Trained junior personnel and provided guidance in the performance of their duties.

• Audited records and documentation for compliance and accuracy following USP/FDA/ICH guidelines.

• Monitored FDA, CDER, FR and other agencies for continual compliance and further the growth of the company.

• Reviewed, evaluated and modified test methods and procedures as appropriate.

Scientist (9/1996 – 9/1997)

• Audited records and documentation prepared by other scientists for compliance and accuracy to ensure compliance with cGLP and cGMP.

• Standard Coordinator responsible for orders, receipt, safe handling and storage, dispensing, destruction and maintenance of the in-house standard program.

• Authored SOP for receiving, dispensing and destruction of standards.

Sr. Chemist (7/1992-9/1996)

• ANDA Submission of Stability data, including summary reports

• Answered FDA deficiency letters

• Audited records and documentation prepared by other scientists for compliance and accuracy

• Reviewed outside lab testing data including validation reports and communicating results to management.

• Resolved issues during RDA inspections.

Sr. Chemist (1/1989-7/1992)

• Performed method development and validation in compliance with good laboratory practices, company SOPs and safety regulations

• Performed assay, related compounds, and/or dissolution analyses of APIs (Active Pharmaceutical Ingredient), raw materials, in-process, finished products, ANDA, and Stability samples using HPLC and/or UV spectrophotometer methods in accordance with USP/NF/BP/EP/company SOPs

• Responsible for Maintenance and Calibration of assigned analytical instrumentation

• Audited records and documentation prepared by other scientists for compliance and accuracy.

• Monthly Status lists on: Stability samples, Drug Substances, Product Development samples, Vendor samples, Finished Product Initial samples, Test Procedures and Stability sample status.

• Ordered Lab Supplies

Chemist (9/1987-12/1988)

• Tested of drug substances and stability samples using HPLC and UV instrumentation.

• Performed dissolution calibration

Camo Water Pollution Inc., Poughkeepsie, NY

Supervisor (1984-1987)

• GC/MS Analyst

• Supervised 3 personnel on second shift and made necessary decisions for the smooth running of the lab. Communicated with management the following day.

• Tested water and waste water according to EPA regulations

EDUCATION:

M.S. Organic Chemistry, University of Bombay, Mumbai, India

ADDITIONAL TRAINING/CONTINUING EDUCATION

• In-house training on lyophilization and regulatory compliance.

• Pittcon Conference at New Orleans in March 2008.

• Gas Chromatography Fundamentals, troubleshooting & Method development on August 13-17 2007 at Chicago, Illinois an ACS short course

• IVT Laboratory Regulations Controls and Compliance, on August, 15-16 2006, at Alexandria, VA.

• Generic Drug Approvals held in February, 2005 at New Brunswick, NJ.

• Gas Chromatography Workshop on November, 2003 at Marlborough, MA.

• How to Develop, Validate and Troubleshoot Capillary GC and HPLC Methods at New Orleans in March, 2002

• Reference Standard Symposium held in October, 2002 at Rockville, MD.

• Agilent LC Chemstation Users Group Meeting held in April, 2001 at Paramus, NJ.

• AAPS workshop on Reference Standards held in May, 2000 at Arlington, VA

• FDA/PQI Laboratory cGMP Conference held in May, 2000 at Paramus, NJ.

• Quality Assurance for Analytical Laboratories conducted by AOAC International in September, 1996 at Orlando, Florida.

• Conducting Effective Quality Audits given by Center for Professional Advancement in April, 1995 at East Brunswick, NJ.

• Drug stability & Shelf-life conducted by Center for Professional Advancement in October, 1993 at East Brunswick, NJ.

TECHNICAL SKILLS

Lab Skills

• RP (Reverse Phase) and Normal Phase HPLC

• GC/MS

• GC

• UV

• IR

• Karl Fisher, Viscosity, Density, Particulate matter

• AA

• Method development

• GMP/GLP compliance

• ACI (Anderson cascade impactor)

• Auditing scientific data

Computer Skills

• Ezchrom

• Empower 1 and Empower 2 Data Acquisition Software (Waters)

• Millenium 32 (Waters)

• Access*Chrom (Perkin Elmer)

• MS office (Word, Excel)

REFERENCES: Furnished upon request

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