Quality Control Analyst & Microbiology Expert with 20+ Years

JAIMINI PATEL

Liberty Township, OH, 513-***-****, ****.*****@*****.***

Professional Summary

Dedicated Quality Control Analyst and Microbiologist with over 20 years of experience within the pharmaceutical, consumer healthcare, and clinical laboratory sectors. Proven expertise in performing high-precision stability testing, analytical chromatography, and complex microbial assays in strict compliance with GMP, GLP, and USP standards. Adept at method validation, laboratory automation, and optimizing workflows to ensure product safety and organizational growth. Technical Skills & Core Competencies

● Analytical Instrumentation: HPLC, LC-MS, UV-Vis Spectroscopy, pH Meters, Karl Fischer Titration, Analytical Balances, Microscope, Autoclave, Solaris, Celsis, FLIPR.

● Microbiology & Cell Biology: Microbial Testing (APC, Yeast/Mold), MIC/MBC Assays, Environmental Monitoring, Aseptic Technique, DNA Transfection, HBO C_C and HEK-293 cell line maintenance.

● Regulatory Compliance: Extensive knowledge of GMP, GLP, GDP, AOAC, USP, CTFA, FDA/BAM, and EPA protocols.

● Software Proficiency: Empower, Agilent ChemStation, LabX, SmartSolve, Smartsheet, LIMS, Cispro, PLM

● Lab Operations: Laboratory 5S, Method Validation/Development, Equipment Calibration, Inventory Management, Technical Training.

Professional Experience

QC Analyst II at Nitto Avecia Cincinnati, OH May 2022 – April 2026

● Conduct routine stability testing on various drug products and oligonucleotides (liquid and solid forms) adhering to GMP and SOPs.

● Performed qualitative and quantitative analysis using HIgh-Performance Liquid Chromatography

(HPLC) and Liquid Chromatography- Mass Spectrometry (LCMS) for raw materials, Release samples, and Stability samples in compliance with GMP standards.

● Conduct method development, optimization and validation for HPLC and UV assay.

● Troubleshoots chromatographic systems, column performance, Mobile phase preparation and instrument maintenance to ensure accurate and reproducible results.

● Utilize Empower and ChemStation software to analyze and interpret complex chromatography data.

● Lead side projects involving method validation and method development to enhance testing accuracy.

● Manage ongoing equipment maintenance, including monthly cleaning and routine calibration of pH meters and Karl Fischer titrators.

● Meticulously document experimental results in laboratory notebooks and digital 'P' drives in accordance with GDP.

● Maintain laboratory efficiency through daily/weekly 5S tasks and proactive inventory management. KAO / Advanced Testing Laboratory Cincinnati, OH March 2021 – May 2022 R&D Microbiologist

● Executed microbiology testing and validation for newly released consumer products across multiple business units.

● Developed and optimized assays to evaluate the efficacy of prototype formulations, including MIC/MBC testing.

● Performed product release testing for finished goods and raw materials using AOAC, CTFA, and USP protocols.

Procter & Gamble / Advanced Testing Laboratory Mason, OH August 2004 – February 2021 R&D Microbiologist

● Conducted product release testing for clinical samples and raw materials using FDA/BAM, USDA, and EPA protocols.

● Managed cell biology projects, including maintaining HBO C_C and HEK-293 cell lines and performing DNA transfections.

● Utilized Celsis rapid detection and FLIPR systems for high-throughput screening of compound libraries.

● Led validation studies, preservative efficacy tests, and time-kill assays on RM and FP for all business units.

● Participate in multiple Clinical Trial study projects. Also help with the hair Annotation Project.

● Served as a primary technical resource, training new hires on laboratory procedures and sampling techniques.

● Performed laser capture microdissection for skin biopsy research. Advanced Testing Laboratories Cincinnati, OH December 2002 – June 2004 Microbiologist

● Conducted microbiological analysis on water, wastewater, and stability samples for quality control.

● Analyzed food products to detect pathogens including E.coli, Salmonella, Listeria Spp., Staphylococcus, and Fecal Coliform.

● Prepared standard media, reagents, and solutions for routine laboratory use.

● Maintained quality assurance by tracking daily lab activity to ensure accuracy and managed inventory records.

Health Alliance Medical Laboratories Cincinnati, OH October 1998 – December 2002 Clinical Technician

● Conducted microbiological testing such as APC, presence for yeast & mold, and streak plating.

● Organized and stabilized body fluids and specimens while preparing them for transport using centrifuges and incubators.

Education & Certifications

● Bachelor of Science in Biology & Botany Gujarat University, India July 1991

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