Project Coordinator Laboratory Assistant

I would like to utilize my full potential for the benefits of organization and to develop myself for growing and challenging career. Pharmaceutical professional with more than10 years of extensive experience in Pharmaceutical Analytical Quality Control and Quality Assaurance. Multi-skilled s with an excellent technical background, strong problem-solving ability. Hands-on experience related to excellent knowledge of cGMP, GLP, and ICH guidelines. Goal-oriented with excellent record keeping and reporting skills. Works well independently as well as within a team to meet company objectives.

AREAS OF EXPERTISE

Expertise in successfully managed analytical QC projects.

Responsible for gathering, interpretation, and presentation of data to support decision making and product analytical strategies.

Strong capability to handle LC related verification, and troubleshooting.

Proficient in draft, review specification, SOP, Validation protocol/ reports.

Maintained and monitor master calibration schedule for laboratory instruments as well as IQ, OQ &PQ.Schedule with vendor for PM& Calibration of Lab instrument and review and approve qualification documents.

Experienced in 21CFR, FDA/DEA/ICH guidance and USP/EP/JP, OOS, Deviation and CAPA.

Experienced in managing and maintaining analytical laboratory with the utmost integrity and in compliance with current GMP and GLP standards.

Review and writing protocols and reports of Analytical method validation/verification, Analytical method transfer as per various guidelines.

Good communication, teamwork and interpersonal skills.

Well-versed in office related computer software like MS-Office (MS Word, Excel, Power point), SAP, Veeva vault.

INSTRUMENTS

Expertise on the handling of various chromatographic instruments such as the HPLC, UPLC, Gas Chromatography.

Spectroscopic Instruments: IR, UV/VIS Spectrophotometer, AA, ICP-OES, ICP-MS.

Particle Size determinations: Malvern Particle size analyzer, Sonic shifter for sieve analysis.

Dissolution apparatus: USP-I, USP-II with Auto sampler system, Potentiometric, Titration and Karl Fisher Titrator, TGA.

PROFESSIONAL EXPERIENCE

Akorn Pharmaceutical Supervisor

Amityville,NY

Nov 2021 – Present

Gathered data and documents test results, reviews test results to ensure compliance with standards; reports any quality anomalies.

Participated in required training activities.

Excellent skills in specialized instruments to solve challenging analytical problems.

Analyzed API, QC Release samples following USP/NF and In house methods using instrumental analysis and wet analysis techniques.

Maintained analytical records to ensure compliance with FDA regulations and Good laboratory Practices.

Recorded proper documentation of experimental, and GMP procedures and results.

Preparing documents for Change Control and raising Change Control.

Vendor Qualification Activity.

Cipla Pharmaceuticals Chemist III

Hauppauge, NY

Nov 2016 – Nov 2021

Utilized various chromatographic techniques such as TLC, HPLC, GC, and MS to identify impurity from sample preparation as well as to perform Assay, RC RS analysis and troubleshooting.Used all laboratory equipment used in routine sample analysis- UV-VIS ( both Empower and Shimadzu) FTIR, Karl Fisher Titrator, pH meter, Conductivity meter, Drying Oven and dissolution apparatus for finished product and stability testing.

Tested all Drug products and collecting data for submission by using software of Empower2.

Maintained accurate lab notebooks and completes all related analysis reports, write summaries and keeps proper documentation in compliance with SOP’s, works with GMP environment.

Prepared and Standardized volumetric solutions, test reagents, indicator solutions.

Gathered data and documents test results, reviews test results to ensure compliance with standards; reports any quality anomalies.

Participated in required training activities.

Excellent skills in specialized instruments to solve challenging analytical problems.

Analyzed API, QC Release samples following USP/NF and In house methods using instrumental analysis and wet analysis techniques.

Maintained analytical records to ensure compliance with FDA regulations and Good laboratory Practices.

Recorded proper documentation of experimental, and GMP procedures and results.

Preparing documents for Change Control and raising Change Control.

Vendor Qualification Activity and Method transferred activity.

Futurebiotics QA Supervisor

Hauppauge,NY

Dec2013- Nov 2016

Tested a wide variety of raw materials and finished products for cosmetic and Nutraceutical companies to ensure they conformed to the proper specifications and regulations following SOP’s or the appropriate method procedure, providing clients with the most up to date and accurate test result.

Trained new analysts on a wide variety of methods and instrumentation.

Maintained and performed preventative maintenance on all laboratory instruments.

Consistently met deadlines to support company policy of one week or less turnaround times by organizing work flow and multi-tasking, providing clients with quick and accurate test results following strict quality control guidelines.

Technical lead and on-site project coordinator for all finished product stability studies, Monitored storage condition, scheduled pull dates for samples and managed testing to ensure that results and reports were delivered to the client on time.

Perform Microbiological test by using Biolumix.

Excellium Pharmaceutical Chemist II

Fairfield, NJ

July2012- Dec2013

Performed analytical analysis of finished product, Stability samples using In House method following SOPs, cGMP and FDA regulations.

Perform Strength, Content Uniformity, and Dissolution& Blend Uniformity utilizing various laboratory instruments such as UPLC, HPLC, UV-VIS, Dissolution and Karl Fisher Titrator.

Analysis of Raw materials for release purpose by Instrumental and Wet Chemistry met.

Calibrate laboratory instruments such as UPLC, HPLC, UV-Visible Spectrophotometer, Karl Fischer Titrator and Dissolution Apparatus.

Time Cap Lab Inc. Chemist I

Farmingdale, NY

Mar 2011- June2012

Routine analytical testing of raw material, API, Stability and R&D samples and in-process samples in accordance with department procedures and specification.

Performing standardization, test equipment like HPLC, UV, IR, Karl-Fisher, TLC, pH meter.

Wet Chemistry: LOD, specific gravity, pH, optical rotation, Appearance and color and sulphated ash.

Education

B.Sc. (Biotechnology)

Internship

6 months Laboratory Assistant work with Microbiological Tests and Chemical Tests of Milk in Kaira District Co-operative Milk Producer’s union Ltd. In Anand, Gujarat, India

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