Vraj Soni

Quality Control (QC) Analyst with 3+ years of experience in pharmaceutical quality control, analytical testing, and GMP-regulated laboratory environments. Performed 1,000+ analytical tests across raw material, in-process, finished product, and stability samples using HPLC, UPLC, GC, UV-Visible Spectroscopy, FTIR, and wet chemistry techniques. Proficient in analytical method validation, instrument calibration, OOS/OOT investigations, CAPA, Empower, LIMS, and compliance with cGMP, GLP, FDA 21 CFR Part 210/211, USP, ICH guidelines, and ALCOA+ data integrity principles.

Knowledgeable in mammalian cell culture and molecular docking, with a strong focus on quality, regulatory compliance, and continuous improvement.

Quality Control Intern - Thermo Fisher Scientific - NY, USA

(2026-05)

• Executed analysis of 150+ raw material and finished product samples using HPLC, UV-Visible Spectroscopy, and pH meter, while preparing reagents, documenting test results, and ensuring compliance with cGMP, GLP, and SOP requirements.
• Coordinated 10+ instrument calibrations, stability testing, and laboratory documentation activities, maintaining ALCOA+ data integrity and accurate analytical records in Empower/LIMS.

Graduate Research Assistant (Dr Benzeroual's Lab) - LONG ISLAND UNIVERSITY - Brooklyn, NY, USA

(2026-01 - 2026-05)

• Managed daily wet lab operations, equipment scheduling, inventory, reagent preparation, and safety compliance, ensuring uninterrupted research activities and audit readiness.
• Performed cell-based assays, automated microscopy, UV-Vis spectrophotometry, RT-qPCR, ELISA, gel electrophoresis, and flow cytometry, analyzing experimental data using R.
• Maintained laboratory documentation, SOPs, and research databases while training 3 junior researchers, improving data quality, protocol compliance, and laboratory efficiency.

Quality Control (QC) Analyst - Cipla - India

(2023-01 - 2024-08)

• Performed analytical testing of 1,200+ raw material, in-process, finished product, and stability samples using HPLC, GC, UV-Visible Spectroscopy, and FTIR, ensuring compliance with cGMP, GLP, USP, and ICH guidelines.
• Executed 40+ analytical method validations, instrument qualifications, and calibration activities while maintaining 100% ALCOA+ data integrity and GMP-compliant laboratory documentation.
• Investigated 35+ OOS/OOT results, supported 25+ CAPA, deviation, and change control activities, and collaborated with QA and manufacturing teams to perform root cause analysis and implement corrective actions.
• Managed analytical records in LIMS/Empower, reviewed 1,500+ chromatographic data sets, and maintained audit-ready documentation during internal and regulatory inspections.

Quality Control Intern - Cipla - India

(2022-03 - 2022-12)

• Prepared and analyzed 500+ laboratory samples using wet chemistry techniques, including titration, buffer preparation, and solution standardization, while adhering to GLP and SOP requirements.
• Performed routine analytical testing using UV-Visible Spectroscopy, pH meter, analytical balance, and dissolution tester, supporting raw material and in-process quality evaluations for 300+ production batches.
• Facilitated 20+ instrument calibration, preventive maintenance, and reagent preparation activities while maintaining accurate laboratory documentation and quality records.
• Recorded analytical observations, maintained laboratory notebooks, and participated in 50+ stability studies and routine quality investigations, ensuring adherence to laboratory safety and quality standards.

Master of Science - Pharmacology and Toxicology - LONG ISLAND UNIVERSITY (2024-09 - 2026-05)