Quality Assurance Raw Material

Mi Na Park

984-***-**** • ********@*****.***

ACCOMPLISHED CHEMIST

Proven expert in GC, HPLC, ICP, analytical and assay methods used on raw material and finished products to assure the quality and purity of the products. Adroit at following USP methods, SOP procedural writing, and cGMP practices.

EXPERIENCE

Merck & Company (Contract) – Elkton, VA January 2024 - Current

Senior Chemist

•Conducted comprehensive analytical testing on pharmaceutical samples, including active pharmaceutical ingredients (APIs) and stability samples.

•Tested both antibody and non-antibody samples for stability under different environmental conditions, ensuring the efficacy and shelf-life of pharmaceutical formulations.

•Utilized Laboratory Information Management System (GLIMS) and electronic laboratory notebook (eLog) to record and manage analytical data, ensuring traceability and accessibility of information for regulatory compliance and quality assurance purposes.

Catalent (Full-time, initially hired as a contractor) – Morrisville, NC December 2021 –July 2022

Associate Scientist

•Operate and maintain advanced mass spectrometry instrumentation, including liquid chromatography-tandem mass spectrometers (LC-MS/MS), for the analysis of protein samples.

•Troubleshoot instrument issues, perform routine maintenance, and implement corrective actions to minimize downtime and maintain optimal instrument performance.

•Train and mentor junior analysts in HPLC, Empower, and mass spectrometry techniques, data interpretation, and best practices, contributing to the professional development of team members.

•Collaborate with interdisciplinary teams to present findings, contribute to project discussions, and provide insights that guide research directions.

Fujifilm Diosynth (Contract) – Morrisville, NC June 2021 – November 2021

Associate Scientist

•Perform Enzyme-Linked Immunosorbent Assay (ELISA) tests for the detection and quantification of antigens and antibodies in various sample types, ensuring high accuracy and reproducibility.

•Prepare and process biological samples, such as blood, serum, plasma, and tissues, using established techniques to ensure the integrity and quality of specimens.

•Operate and maintain laboratory equipment, including thermal cyclers, real-time PCR instruments, plate readers, and spectrophotometers, performing routine calibrations and maintenance checks.

GlaxoSmithKline (Contract) – Zebulon, NC February 2020 –January 2021

Bench Chemist

•Utilized the Next Generation Impactor (NGI), Next-Generation Spray Rig System (NSRS), and Next-Generation Dispersion System II (NDSI) to conduct testing on dry powder inhalers (DPIs), providing critical insights into particle size distribution and aerodynamic behavior.

•Conducted comprehensive testing on release and stability samples, employing UV spectrometry to determine key parameters such as Content per Blister and Identity, contributing to the assurance of product quality and consistency.

•Utilized the Laboratory Information Management System (LIFT) to meticulously document and manage laboratory activities, from sample receipt and preparation to data analysis and reporting, maintaining a thorough and traceable record of all testing procedures.

Pfizer – Rocky Mount, NC October 2018 – September 2019

Laboratory Analyst II

•Operated a diverse range of advanced analytical instruments, including pH meters, Karl Fischer titrators, Coulometers, Polarimeters, UV-VIS spectrometers, and Auto Titrators, to perform accurate and precise measurements on raw materials, in-process samples, and finished products.

•Utilized laboratory information management systems (LIMS) to meticulously record, manage, and organize analytical data, ensuring data integrity and traceability throughout the testing process.

•Assumed the critical responsibility of being the Control Drug Agent, managing and overseeing the handling, storage, and usage of controlled substances in accordance with stringent regulatory guidelines.

Procter & Gamble - Browns Summit, NC May 2014 – May 2017

Raw Material Laboratory Technician, September 2016 – May 2017

Calibrated and maintained HPLC and GC to ensure accurate analysis results in compliance with procedures and GLP requirements.

•Conducted analysis and testing per current USP methods or compendia requirements.

•Maintain and calibrate laboratory equipment, including HPLC, FTIR, and UV-Vis spectrometers, to ensure accurate and reliable measurements.

•Analyze and interpret data using statistical tools and software, generating reports that provide insights into raw material quality and consistency.

•Participate in internal and external audits, assisting with documentation and providing information on raw material testing procedures.

•Maintain effective communication with cross-functional teams, sharing analytical results, insights, and recommendations to support product quality and innovation.

Quality Control Laboratory Technician, May 2014 – September 2016

Tested toothpaste, deodorant, and skin care products for wet chemistry while complying with cGMP and GLP adhering to SOP’s.

•Expertly performed a range of tests including viscosity, titration, pH measurements, and Fourier-transform infrared spectroscopy (FTIR) analysis, delivering accurate and reliable results vital for product evaluation.

•Actively contributed to the professional development of entry-level laboratory technicians by providing comprehensive training on laboratory techniques, protocols, and safety procedures.

•Entered and managed analytical data in the SAP online database, facilitating efficient data tracking and retrieval for quality control and reporting purposes.

EDUCATION

Bachelor of Science: Biochemistry - The University of North Carolina at Greensboro, NC

Certified Hazardous waste manager

SKILLS

•Computer skills: Microsoft Word, Microsoft Excel, Microsoft Power Point, Microsoft Access, LIMS, LIFT, Empower, Chromeleon, and Chemstation.

•HPLC, LC-MS, GC, IC, ICP, AA, Xevo G2-XS QTof Quadrupole Time-of-Flight Mass Spectrometry, TOC, FTIR, TLC, Isolator, Karl Fischer, Coulometer, Auto Titrator, UV-VIS, Polarimeter, NGI, and NSRS.

•USP/NF, cGMP, GLP, CAPA, OOS, ALCOA, SAP, 5S, Lean Lab, and Safety Regulations (OSHA)

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