Summary
Overview
Work History
Education
Skills
Timeline
Generic

Nishchay Patel

Edison,NJ

Summary

Detail-oriented and experienced Quality Control Microbiologist. Skilled in microbiological testing, environmental monitoring, and ensuring compliance with industry regulations. Seeking to contribute expertise in quality assurance and microbiological analysis to a dynamic team.

Overview

8
8
years of professional experience

Work History

Quality Control Microbiology Specialist

Legend Biotech
Raritan, New Jersey
03.2025 - Current

Quality Control Microbiology Officer

Amneal Pharmaceuticals
Ahmedabad, Gujarat
10.2023 - 12.2024
  • Performed Method validation of Raw material and in-process samples and prepared summary reports
  • Generated and executed Microbial Method validation protocols and reports including the writing, reviewing and approval of summary documentation
  • Created procedures for microbiological testing and sampling in alignment with global procedures and regulation including USP, BP, IP, ISO and EU
  • Performed sterility testing of finished product
  • Prepared monthly, quarterly and yearly trend data and summary reports of pharmaceutical water
  • Executed daily water sampling planning and preparation of water sampling schedule

Quality Control Microbiology Officer

Intas Pharmaceuticals
Ahmedabad, Gujarat
02.2021 - 09.2023
  • Conducted routine microbiological testing of raw materials, in-process samples, and finished products using methods such as microbial limit tests and bioburden
  • Assisted in writing, reviewing and editing protocols, reports and SOPs
  • Documented test results and ensured timely entry into LIMS for reporting
  • Investigate out-of-specification (OOS) and environmental monitoring excursions, conducting root cause analysis and implementing corrective and preventive actions (CAPA)
  • Conducted routine water sampling, microbial, endotoxin and chemical analysis of water as per SOP
  • Performed viable and non viable Environment Monitoring in clean room

Quality Control Microbiologist

Swiss Parenterals Ltd.
Ahmedabad, Gujarat
08.2020 - 01.2021
  • Prepared environment monitoring rationale for area qualification
  • Perform environment monitoring using air sampling (active and passive methods), surface sampling (contact plates, swabs), and personnel monitoring to detect microbial contaminants, Monitoring non-viable particulates using particle counters in cleanrooms
  • Prepared environmental monitoring trend data and summary

Microbiology Laboratory technician (Part time)

Green cross pathology and molecular laboratory
Ahmedabad, Gujarat
11.2017 - 07.2020
  • Operated Automated Vitek 2 compact system (By bioMerieux) for identification and to check antimicrobial susceptibility test for aerobic organisms and yeast
  • Proficiency in culturing, isolating, and identifying microorganisms (bacteria, fungi) using techniques such as streak plating, serial dilution, gram staining and microscopy
  • Ability to perform collecting, labeling, and preparing biological samples for microbiological testing, ensuring adherence to standard operating procedures (SOPs)
  • Proficient in recording, analyzing, and interpreting microbiological data using both manual and automated systems. Ability to prepare detailed reports and communicate results to healthcare professionals

Education

Post Graduate Diploma - Clinical Laboratory Science

Swarnim University
Gandhinagar, Gujarat, India
05-2021

Master of Science - Microbiology

KSV University
Gandhinagar, Gujarat, India
05.2020

Bachelor of Science - Microbiology

Gujarat University
Ahmedabad, Gujarat, India
05.2017

Skills

  • Microbiological testing
  • Method validation
  • Quality control
  • Data analysis
  • Safety regulations
  • Root cause analysis

Timeline

Quality Control Microbiology Specialist

Legend Biotech
03.2025 - Current

Quality Control Microbiology Officer

Amneal Pharmaceuticals
10.2023 - 12.2024

Quality Control Microbiology Officer

Intas Pharmaceuticals
02.2021 - 09.2023

Quality Control Microbiologist

Swiss Parenterals Ltd.
08.2020 - 01.2021

Microbiology Laboratory technician (Part time)

Green cross pathology and molecular laboratory
11.2017 - 07.2020

Post Graduate Diploma - Clinical Laboratory Science

Swarnim University

Master of Science - Microbiology

KSV University

Bachelor of Science - Microbiology

Gujarat University

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