Rinal Shah
Bloomingdale,IL
Summary
. Highly analytical Analyst with sound experience in data interpretation, statistical analysis, and trend forecasting. Strengths lie in problem-solving ability, strategic thinking, and exceptional technical skills such as proficiency in SQL and Excel. Showcased impact by contributing to data-driven decision making that increased efficiency and improved business outcomes in previous roles.
Overview
15
15
years of professional experience
Work History
Analyst III
Fresenius Kabi
Melrose Park , IL
02.2023 - 04.2024
- Worked in Finished Product Chemistry group
- Utilize LIMS program for visuals testing, pH and Uniformity of Dosage Units, volume checks, and reconstituting vials to perform testing for finished products
- Also performed testing for CMO IDs
- Verification of the analytical balance & pH meter & light meter box
- Experienced in several instruments such as particulate matter, light meter box, pH meter
- Performed USP identification testing per current USP
- Performed review of logbooks per cGMPs
- Performed peer review of data to ensure compliance and accuracy
- Prepared standard, reagent and sample solutions using proper documentation pathways
- Provided analytical support for Out of Specification (OOS)/Out of Trend (OOT) results to investigate the root cause and wrote LIR reports
- LIMS Access Support
- Good housekeeping practices and follow safety procedures
- Interpreted and followed USP/NF monograph requirements.
Chemist
First Priority, Inc.
Elgin , IL
09.2021 - 11.2022
- Worked under minimal supervision, responsible for the basic testing of raw materials, in-process, finished products and stability testing for release according to specified test methods and specifications (including proper documentation of test results)
- Prepared mobile phase and standards and reagents for in-process, finished products and stability testing
- Analyze samples by HPLC instruments and performed wet chemistry testing such as pH, viscosity, specific gravity (by pycnometer), and densitometer, titrations, TLC apparatus, UV-Vis, and Karl Fischer too
- Performed various functions supporting the product stability program
- Provided organization support to the product stability program by including/removing stability samples from stability chambers when required
- Changed temperature/humidity charts on chambers as required
- Generated stability calendar for each month
- Tested water samples on a daily and monthly basis
- Performed raw material testing such as description/appearance test, odor test, IR, flame test, residue on ignition, assay, loss on drying, and pH.
Chemist
Catalent Pharmaceutical Co.
Woodstock , IL
09.2015 - 12.2016
- Performed analytical testing and calculations on raw materials, in-process bulk material, finished product, cleaning, customer and stability samples
- Operated analytical instrumentation such as FTIR & UV
- Prepared test reports and performed cGMP documentation in all areas of the laboratory
- Performed peer review of documentation
- Maintained current record of raw material specifications and compendia guides such as USP/NF
- Interfaced with regulatory agencies and customers
- Assist with audits as needed
- Maintained inventory of standards, chemicals, reagents and supplies, prepared reagents needed for testing
- Prepared glassware and supplies needed for testing and other duties as assigned
- Provided testing support for Out of Specification (OOS) investigations and non-routine events and laboratory investigation reports (NRE & LIR).
Chemist
Chem-Impex, International Co.
Wood Dale , IL
01.2014 - 07.2015
- Worked with UV, IR, NMR, Karl Fischer titration for moisture determination equipment
- Performed raw materials/reagent grade chemicals for wet chemistry testing such as color, clarity, pH, identification, and titration
- Monitored product quality indifferent stability environment and notify respective chemist on any noticeable changes in parameters like viscosity, pH, color, turbidity, total dissolve solids, suspend solids and appearance
- Interpreted and analyzed data, compiled results, prepared reports and presented conclusions
- Followed protocol and safety rules during experiments and verified functioning of instrument and test procedures.
Chemist
Wockhardt Pharmaceuticals
Morton Grove , IL
05.2009 - 03.2013
- Performed wet chemistry testing of raw materials, stability samples, and finished products for release according to specified test methods and specifications (including proper documentation of test results)
- Received all incoming samples to be tested by the QC laboratory
- Logged samples into appropriate log books and into SAP
- Maintained an accurate worksheet with daily updates as to the testing/release status of all material lots (raw materials, finished products, stability, and miscellaneous sample testing)
- Maintained the official sample receipt logbooks used during compliance inspections
- Experienced in wet chemistry with use of instruments such as UV/Vis Spectrophotometer, IR Spectrum, TOC, Conductivity meter, pH meter, viscometer, densitometer, Karl Fischer, furnace, ovens, burners, analytical balances, stir plates, hot plates, moistures balance (Loss on Drying), use of burettes for titrations, and pipetting
- Performed testing on in-process samples such as optical density testing on suspensions
- Performed pH adjustment on in-process samples
- Interpreted and followed USP/NF monograph requirements.
Education
Bachelor of Science in Biochemistry -
Temple University
Philadelphia, PA12.2005
Skills
- Audit Support
- Workflow Analysis
- Root Cause Analysis
- Report Preparation
- Information Gathering
- Issue Identification
- Risk Mitigation
- System Analysis
References
Available upon request.
Timeline
Analyst III
Fresenius Kabi
02.2023 - 04.2024
Chemist
First Priority, Inc.
09.2021 - 11.2022
Chemist
Catalent Pharmaceutical Co.
09.2015 - 12.2016
Chemist
Chem-Impex, International Co.
01.2014 - 07.2015
Chemist
Wockhardt Pharmaceuticals
05.2009 - 03.2013
Bachelor of Science in Biochemistry -
Temple University
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