QUALITY MANAGEMENT

Manage stability programs for commercial drug products including API, unlabeled/
labeled vials, cartridges, and pens in the cGMP environments. Write stability pr
otocols, review, and approve stability data. Revise and approve Test Methods, Pr
oduct Specifications. Proven success in supporting multi-cGMP manufacturing proc
esses with aggressive timelines. As a former USP Chemist with over 14 years of e
xperience in QA Review / QC Testing / ARD method development. Qualification and
Standardization of USP Reference Standards for use testing of by pharmaceutical
drug products. Strong interpersonal and communication skills with an ability to
work in a fast-paced team environment or independently. Hands-on experiences wit
h OOS / OOT investigations and troubleshooting HPLC analysis. Experience with fo
llowing instrumentations:
HPLC/LC-MS / GC-MS
UV/Vis Spectrometers
Dissolution
Particle Size (Malvern, Horiba)
KF Moisture Analysis
FT-IR
Disintegration Tester
PROFESSIONAL EXPERIENCES
AMYLIN PHARMACEUTICALS INC., SAN DIEGO, CA 02/2005-08/2010
Sr. Quality Assurance Analyst, LQA, Quality Operation Department
Managed stability program for commercial drug product including API, unlabeled/l
abeled vials, cartridges and pens.
Wrote stability protocols, review and approve stability test methods and specifi
cations.
Initiated and followed through OOS and OOT investigational reports.
Wrote stability sections for APQR (Annual Product Quality Reports).
Wrote deviation reports for stability data for drug products and drug substances
.
Initiated and completed CCR (Change Control Report) for Stability Protocols and
analytical Methods.
Prepared and completed stability reports including statistical analysis of stabi
lity data.
Performed Accurate, thorough and timely review of analytical data and entry into
LIMS.
Followed up on observations, findings, and corrective actions for QA reviews.
Trended release and stability result data using SLIMStat and JMP analysis tools.
Performed of shelf-life projections using validated statistical packages of SLIM
stat software.
Prepared and assisted project manager to write APQR for commercial drug products
.
Reviewed and approved Standard Operating Procedures and Test Methods for commerc
ial and Investigational drugs.
Assisted in LIMS report format definition, and with LIMS training and validation
exercises.
Performed DIR for Annual Report and APQR, IND, and In-house analytical data for
early stated drugs.
Performed external audits for contract service providers and write assessment an
nual reports.
PFIZER, INC., LA JOLLA, CA 12/2003-02/2005
R&D Associate Scientist, ARD Laboratory
Managed and coordinated stability studies with outside contract laboratories.
Set up and coordinated stability studies for new pharmaceutical products.
Wrote internal SOPs, test methods, and product specifications.
Wrote method development, validation and stability summary reports.
Supported development of drug substance and various types of drug products (i.e.
tablets, capsules, nasal spray and lyophilized products) using HPLC, GC, KF, an
d UV/Vis instrumentations.
Performed method transfers for contract lab and other Pfizer manufacturing site
for in-house testing in QC-ARD. Validated testing methods for stability-indicati
ng assay, content uniformity, related substances, dissolution and cleaning resid
ual validation.
CENTOCOR INC., SUBSIDY OF JNJ COMPANIES, MALVERN, PA 10/2001-12/2003
Analytical Chemist III, Quality Control Department
Trained new analysts in analytical techniques to perform certain assays
Performed analytical testing of Nephelometric assay, using Array 360 System
Evaluated and analyze the Bio-images of SDS Page Gels, using Bio-image Visage 11
0
Performed SDS Page Excel worksheet and transfer data into LIMS
Performed OD280 assay, protein determination using Beckman DU-65 spectrophotom
eter
Reviewed external testing results from outside Laboratory and transfer them into
LIMS
Audited and reviewed analytical laboratory notebooks and documentation for final
release

USP CONVENTION INC., ROCKWILLE, MARYLAND 08/1999-10/2001

Analytical Chemist II, Reference Standard Laboratory
Reviewed chemists laboratory notebooks and projects data for final approval
Trained new chemists in methods and techniques to ensure proper cGMP followed
Evaluated the USP reference standard for uses in pharmaceutical industry
Performed various analytical tests for reference standard evaluation, using HPLC
, FTIR, Raman, and UV/VIS spectrophotometer
Expertise in evaluating enzyme materials of reference standard using special KF
titrations
GLOBAL PHARMACEUTICALS CORP. PHILADELPHIA, PA 06/1997-08/19
99
Analytical Chemist, Quality Control Laboratory
Qualified raw materials designated for use in production of pharmaceuticals
Performed various analytical assays using HPLC, TLC, FTIR and UV/VIS spectrophot
ometer
Prepared and standardized volumetric and test solutions in order to perform raw
material and dissolution testing according to USP methods
Analyzed stability and finished products for release using HPLC instruments
Proficient in the use of Waters HPLC, Spectrophotometer, FTIR, Vankel
Performed calibration and preventive maintenance of laboratory equipment
Managed routine troubleshooting and calibration of QC laboratory instrumentation
Reviewed colleagues laboratory notebooks and data for submitting to QA for final
reviews
EDUCATION
Bachelor of Science in Analytical Chemistry
Temple University, Philadelphia, Pennsylvania
CERTIFICATIONS
Certified member of American Chemical Society
Certificate of Operational Excellent Project
Certificates of Achievement in special HPLC Training by Agilent Technologies
Certificates of Achievement in special HPLC Training by Waters Corporations
Certificate of Biotech for Beginners, April 2002
Certificate of the Standard for Leadership, October 2002
Certificate of the Situational Leadership, December 2002