Khushbu Dhansukhbhai Patel
Piscataway,NJ
Summary
Highly motivated and results-oriented Quality Control professional with over 6 years of experience in the medical device industry. Proven ability to perform a wide range of analytical tests, manage quality systems, and ensure compliance with regulatory requirements. Skilled in aseptic techniques, microbiological testing, and instrumental analysis. Eager to contribute expertise to a dynamic and quality-focused organization.
Overview
11
11
years of professional experience
Work History
QC Associate
Core Pharma
03.2023 - Current
- Performed assigned sampling, physical, and chemical tests on raw materials, APIs, in-process, and finished products using various techniques.
- Reviewed analytical data and generated Certificates of Analysis.
- Conducted web testing, prepared pre-paid COAs, and performed Karl Fischer moisture analysis.
- As a method development chemist in R&D, I specialize in developing and validation of analytical methods. I am an expert in using many devices including HPLC, IR, UV, KF and Malvern. My proficiency is spread to empower the software, where I am skilled in advanced tasks and automated calculations.
Senior Executive Q.C. (Microbiology)
Shaili Endoscopy
10.2018 - 10.2022
- Performed bioburden, sterility testing, LAL test, swab and finger testing, and culture transfer in a cleanroom environment.
- Conducted environmental monitoring and coordinated GPT (Growth Promotion Testing).
- Researched, documented, and examined microorganisms for identification and classification.
- Maintained and updated microbiological procedures, performed validation studies, and calibrated equipment.
- Prepared technical documents, stability data & protocols, and validated stability indicating methods.
- Managed QMS administration and monitored change controls, GMP deviations, and SOPs.
QC Microbiologist
Canton Laboratory Pvt. Ltd
07.2016 - 09.2018
- Prepared various types of media agars and broths, performed area monitoring, and analyzed raw materials and packing materials.
- Conducted media and autoclave validation, performed BET testing, and prepared Certificates of Analysis.
- Monitored GMP records and participated in internal & external audits.
Officer
Helvina Pharmaceutical Pvt. Ltd
06.2015 - 07.2016
- Analyzed and tested raw materials, packaging materials, finished goods, actives, and intermediates using analytical instruments.
- Calibrated/verified analytical instruments and balances, prepared test solutions & reagents, and reviewed/updated specifications.
- Ensured completeness and accuracy of batch release documents, maintained calibration records, and prepared analytical reports/certificates.
Education
PGDMLT (Post Graduate Diploma) - Medical Laboratory Technology
Indian Institute
01.2018
M.Sc. - Biotechnology
A.N. Patel P.G. Institute
01.2015
B.Sc. - Biotechnology
N. V. Patel College
01.2013
Skills
- Microbiology: Aseptic Technique, Bioburden Analysis, Sterility Testing, Environmental Monitoring, Media Preparation, Microbiological Assays
- Quality Control: Internal & External Audits, CAPA, Change Control, cGMP, SOP Development, Validation (Methods, Instruments, Equipment, Cleaning)
- Analytical Techniques: Dissolution, UV-Vis, IR, Particle Size Analysis, Karl Fischer, Titration, pH Meter, Hot Plate, Dissolution Tester, Disintegration Tester, Friability Tester, Hardness Tester, Melting Point Apparatus
- Instruments: Universal Testing Machine, PH Meter, UTM Software, Pouch Burst Tester, Vernier Caliper, Analytical Balance, Conductivity Meter, Weight Balance
- Microsoft Office Suite (Word, Excel, Outlook)
- Laboratory Information Management Systems (LIMS) (experience may vary)
Languages
English
Full Professional
Hindi
Native or Bilingual
Additional Information
- Project: NIR-based Food Analyzer for Testing Skimmed Milk Powder at Amul Dairy (India)
- Conference: Department of Microbiology & Biotechnology Center (International Conference)
Area of Interest
- Microbiology
- Quality Control & Assurance
- Internal Audit
Disclaimer
I confirm the information provided is true to the best of my knowledge.
Timeline
QC Associate
Core Pharma
03.2023 - Current
Senior Executive Q.C. (Microbiology)
Shaili Endoscopy
10.2018 - 10.2022
QC Microbiologist
Canton Laboratory Pvt. Ltd
07.2016 - 09.2018
Officer
Helvina Pharmaceutical Pvt. Ltd
06.2015 - 07.2016
M.Sc. - Biotechnology
A.N. Patel P.G. Institute
B.Sc. - Biotechnology
N. V. Patel College
PGDMLT (Post Graduate Diploma) - Medical Laboratory Technology
Indian Institute