Quality specialist

PROFESSIONAL SUMMARY

Effective, energetic pharmaceutical Quality professional with strong analytical background. Excellent organization skills and documentation abilities. Nineteen years of experience as a senior chemist in the QC Department. Trained new chemists and audited their laboratory data and notebooks as per cGMP compliance.

Technical Skills:

Working knowledge of HPLC (Perkin Elmer, Shimadzu), Dissolution (Distek, Vankel), TLC, FT-IR (Nicolet-iS10), and UV/VIS (Hitachi U-2900), and Karl Fisher (Metroohm), SAP and Agilent.

Reviews laboratory test notebooks and batch records documentation for data accuracy and cGMP compliance

Authors, reviews and revises SOP as directed by QC, Customers and QA management.

Work closely with QA, Production, DEA, Stability and Finished Products Group to achieve goals.

Turbo chrome Version 4.0 & 6.2.1GCMS, NMR, GC/IR, FT-IR, Bomb Calorimeter, Refractometer Index, Atomic Absorption, UV/Vis, Auto-titrator, Viscometer, Karl Fisher, Polarimeter, HPLC (PE, Shimadzu, Agilent), and Dissolution Unit (Distek, Vankel)

Computer: IBM AND Macintosh

Computer Applications: Microsoft Word, Excel, Power Point, and Lotus.

PROFESSIONAL EXPERIENCES

Lohmann Therapy System, West Caldwell, NJ - (June 2000 – Present)

Senior QC Chemist

Completes transactions in SAP to release the batch

Working knowledge with method transfers: related substance, content uniformity, DL/QL, Linearity, dissolution tests.

Calibrated Dissolution Unit and HPLC by USP/NF method.

Trained new chemist as per cGMP for HPLC as well as Total chrome.

Reviews analyst’s laboratory notebook and their chromatograms to maintain cGMP compliance.

Perform routine analysis on various types of raw materials of in process, finished and stability products as well as different stages of testing for raw material by USP/NF method.

Prepares COA for batch disposition. Acts as a designee in the absence of my manager.

Work closely with QA, Production, DEA, Stability and Finished Group.

Maintaining the lab for inspection readiness at all time.

Provided satisfactory responses to EMA and FDA (PAI and GMP) inspection that resulted in successful launch of block buster product.

Reckitt & Colman Inc., Montvale, NJ – (September 1997 – April 1999)

Analytical Scientist

Expertise in HPLC, GC, FT-IR, Titration, Assay, Florence Detector, UV/Vis, Auto titrator

Helped in the de-formulation of competitors products and performed various wet chemistry techniques.

Performed various analysis using chromatography and spectroscopic techniques

Conducted GLP studies for stability samples.

Unigene Pharmaceutical Company, Boonton, NJ (March 1997 – May 1997)

Consultant Chemist

Scheduled and tracked on time PM and calibration of laboratory equipment to improve compliance.

Performed assay testing for stability sample using isocratic and gradient method for HPLC.

Verified chemist’s laboratory notebook and their Chromatograms to maintain cGMP compliance.

Rutgers University, Newark, NJ (October 1995 – March 1997)

Teaching & Research Assistant

Conducted research with Birch Reduction using NMR, IR, GCMS, and TLC.

Responsible for grading and assisting undergraduate students.

Environmental Protech, West Milford NJ (August 1996 – December 1996)

Analytical Chemist

Performed wet chemistry for solid samples. Responsible for phenol, cyanide and fluoride distillation.

Other Experience – (December 1991 – December 1993)

Volunteer/ Pharmacist Assistant, Morristown Memorial Hospital, Morristown, NJ

EDUCATION

Rutgers University, Newark, New Jersey: Bachelor of Science, May 2000

Concentration: Chemistry

County College of Morris, Randolph, New Jersey, June 1994

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