Stability Study Specialist

• Jul 2021 - Present

• Responsible for conducting GMP stability study for 30 on-going batch.• Responsible to write Standard Operating Protocols (SOP) for new stability products to include product handling, packaging, and study conditions in compliance with GDP.• Organize Stability pulls and communicate with the Quality control department regarding the analytical testing of the sample to meet the timeline of the study.• Responsible for Stability technical data review and to maintain an Interim report of the sample throughout the study.• Perform investigation of Quality events such as Laboratory Investigation and Quality Investigation for Out of Specifications and Out of Trend results to determine the root cause using the 5 why or Fishbone method and assign related corrective action with CAPA’s.• Responsible to write Change Control for retest date extension of API’s in compliance with FDA and ICH guidelines. • Perform Quarterly Stability Chamber Inventory, Chamber mapping and Performance maintenance of chambers. • Communicated well with the Project managers and Customers regarding Stability study.• Participate in triage meeting with Quality team to manage time and resources well.

Quality control anlyst

• Nov 2018 - Jul 2021

• Performed various In-process sample testing and final product testing in a GMP facility and provided appropriate documentation and results.• Executed Stability studies for various products from time to time.• Conducted reference standard qualification for In-house and other standards.• Operated analytical instruments such as High-Performance Liquid Chromatography (HPLC), Ultra Performance Liquid Chromatography (UPLC), Gas Chromatography (GC), Gas Chromatography-Mass Spectrometry (GCMS), Polarimeter, Ultraviolet–visible spectroscopy (UV-VIS), Karl Fisher, Fourier Transform Infrared Spectroscopy (FTIR) and Malvern Particle size analyzer according to the SOP. • Measurement of Molecular weight of a sample by Gel permeation chromatography (GPC/SEC) software.• Performed HPLC testing of quality control assays and chromatographic purity test.• Performed specificity, linearity, accuracy, and precession testing according to method validation protocols.• Performed Cleaning Validation of various API’s. • Maintained cGMP Documentation.• Carried out annual calibration for HPLC and GC to match industry standards. • Effectively communicated test results and reports to QC supervisor.• Executed secondary data review for analyses of other analysts.• Responsible and able to work in a fast-paced environment, manage priorities, and maintain timeline for multiple projects.

Research Intern

• Feb 2018 - Nov 2018