Quality Control Assurance
Resume:
BABU RAVAL *** College Drive, Edison, NJ *****
E-mail: *********@*****.***
Cellular: 732-***-****
ANALYTICAL CHEMIST
Thirteen years of experience as a professional Analytical Chemist in laboratory analysis and technical services with expertise in the area of pharmaceutical analysis, laboratory practices, and quality control testing.
Strong quantitative and quality skills in analytical chemistry.
Excellent theoretical and practical knowledge and experience in HPLC, GC, TLC, UV-VIS, IR analysis and wet chemical techniques.
Proven ability to manage multiple responsibilities in a fast-paced environment with critical deadlines.
Able to work independently as well as collaboratively in a team setting.
PROFESSIONAL EXPERIENCE
2015-08/15/2016 Impax Pharma Inc. Piscatway, NJ
ANALYTICAL CHEMIST
Performed quality control testing on Finished Product, Stability,Complaint Sample,Protocol Samples and process validation samples.
Performed Tablets and Capsules Dissolution Single point and Multi point by (UV-VIS) and by HPLC.
Conducted Identification by HPLC, IR, and TLC, Assay and degradation test of actives.
Performed quality control testing of blend uniformity, dissolution profiles, assay and content uniformity on finished products by HPLC and UV-VIS spectrophotometer.
Performed the Karl-Fisher titration on finished and stability product.
Audits laboratory notebooks and raw data
2013 – 2014 Hemispherx Biopharma Inc, New Brunswick, NJ
AN LYTICAL CHEMIST
Total organic carbon (TOC) measurement in water for injection (WFI), purified water and clean steam water by portable total organic carbon analyzer (Sievers-800).
Offline conductivity measurement for WFI, purified water and clean steam water by orion model 115 conductivity meter.
Spectral analysis for poly-I and poly C12U samples.
Low molecular weight impurity determination for poly-I and poly C12U samples using paper chromatography.
HPLC assay for measuring the molar ratio of cytidine to uridine (C:U) in poly C12U.
Phenol analysis by GC.
HPLC assay for determination of impurities in ampligen, poly-I and poly C12U samples.
HPLC method for inosincdiphosphate, cytidine diphosphate and uridinediphosphate and respective related impurities.
Testing quantify protein levels in ampligen samples.
Testing for measuring the amount of inorganic and total phosphorus in poly-I and poly C12U samples.
Audits laboratory notebooks and raw data
2003 – 2012 MERCK, INC., Union/Kenilworth, NJ
ANALYTICAL CHEMIST
Performed quality control testing on raw material, finished product, stability, complaint, protocol samples and process validation samples.
Tested quality control on description, APHA color by UV-VIS, ID by HPLC, ID by TLC, weight of degradation, emitted dose uniformity, particle size distribution by cascade impaction and wet chemistry.
Received samples, tested, maintained records, interpreted and reviewed data, reported scientific results and organized batch records for release by following company’s procedures and regulations.
Trained new analysts on operating procedures and testing protocols.
Participated in the investigation and release, stability, and complaint samples and entering data generated into LIMS. (Nucleus) system and quality assurance system using Empower and Excel.
Supported pharmaceutical dosages forms and API analytical testing in a GMP environment.
Maintained compliance with applicable cGMP, GDP, GLP and OSHA safety regulations.
Performed tablets and capsules dissolution tests (UV-VIS) tablets and capsules dosage uniformity tests by HPLC.
Conducted active identification by HPLC, IR and TLC, assay and degradation tests of actives.
Audits laboratory notebooks and raw data
2001 - 2003 SIDMAK LABORATORIES, INC., East Hanover, NJ
ANALYTICAL CHEMIST
Managed analysis of In-Process, validation of drug product and NDA samples.
Performed quality control testing of blend uniformity (Unit dose), dissolution profiles, assay and content uniformity on validation of drug product by using HPLC, Millennium 4.0, and UV-VIS spectrophotometer.
Managed the Karl-Fisher titration on validation of drug product.
Set up and calibrated laboratory instruments such as distek dissolution unit, UV-VIS spectrophotometer.
Conducted sieve analysis, tap density, practical size and bulk density.
Audits laboratory notebooks and raw data
1999 – 2001 GUARDIAN DRUG COMPANY, INC., Dayton, NJ
ANALYTICAL CHEMIST
Performed quality control testing on raw material, finished product, stability, complaint, protocol samples and process validation samples.
Tested samples of stability for product stability evaluation.
Instituted analytical methods for UV-VIS spectrophotometer, FTIR, AAS, HPLC, and digital turner fluorometer.
Performed dissolution on finished and validation samples with distek dissolution test system following USP methods.
Prepared the Karl-Fisher titration, loss on drying and residue on ignition test for raw materials and finish products.
Managed sieve analysis by micron powder system, tap and bulk density, testing tables, and caplets of physical parameters by using PTB311.
Master of Science in Inorganic Chemistry, Gujarat University, Ahmedabad, India
HPLC Analytical Technician Certification, Bound Brook, NJ
Six Sigma Certification, MERCK, INC., Union/Kenilworth, NJ
CGMP Laboratory training certification, MERCK, INC., Union/Kenilworth, NJ
MS Word, Excel, Power Point, Empower, QAS, Nucleus or LIMS.
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