Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic
Jeonghye Shin

Jeonghye Shin

Ansan

Summary

Quality Control Specialist with over 3 years of experience in pharmaceutical and cosmetic analysis. Known as the only contract employee authorized to test Tylenol and Listerine, and qualified to train new employees based on that expertise. Experienced in Validation (method, process), Excel CSV, Creation and Revision of WI(Waste management, Pest Control, Gas safety, Eyeshower, Dehumidifier), Test specification (All kinds of Listerine), Participation in the selection of LIMS vendors, Laboratory management, and implementing quality improvements that reduce costs and enhance compliance. Seeking to leverage expertise in analytical testing, documentation, and continuous improvement in a global pharmaceutical company.

Overview

5
5
years of professional experience
1
1
Certification

Work History

QC Analyst

Kenvue Korea
11.2024 - Current

Conducted physical and chemical testing of Tylenol and Listerine

  • HPLC, GC, UV-vis, AA, and pH meters etc


Sole contract employee certified to perform both Tylenol and Listerine tests; trained new employees independently.


Reviewed data using Empower managed documentation and communicated corrections with manufacturers.


Supported Excel CSV activities and CAPA projects.


Prepared for GCC inspection, including development of WI, EFRM, and FRM (Standard Time synchronization, dehumidifiers).


Conducted root cause analysis training on gas safety and error prevention.


Managed consumables procurement (price comparison, selection, receipt confirmation).


Set and achieved personal OKR to master both Tylenol and Listerine testing; maintained zero LIRs through proactive learning.


Took lead R&Rs among contract staff identified process gaps and revised WIs (pest control, eyewash stations, waste management, gas safety).


Revised test specifications for all Listerine products.

Quality Control Specialist

Hwaeil Pharmaceutical Co.Ltd.
02.2022 - 04.2024

Performed analytical testing of API, Finished Good Products and Materials


Led Process Validation and Method Validation

: Purity, Residual Solvents, Dissolution and Assay of API and

Finished Good Products


Managed equipment Performance Qualification (PQ) scheduling and conducted internal calibration


Proposed and initiated LIMS system setup to reduce manual error and enhance workflow efficiency


Conducted equivalency dissolution

tests following regulatory guidelines, ensuring successful validation of process upgrades


Performed periodic revisions of work instructions (WIs), translated test methods from raw material manufacturers, and documented test results in laboratory reports


Responsible for reagent management, including assigning control numbers, maintaining CoA and MSDS documentation, and overseeing inventory


Responsible for creation and management of the reference standard masterlist (working standards/reference standards), including control number assignment and inventory tracking


Performing stability test for Finished Good Product


Performing Stability test of Mobile phase to reducing payment of test.

Analytical Chemist (Contract)

Korea University Ansan Hospital
06.2021 - 12.2021

Analyzed hazardous substances in workplace environments using UPLC, GC, ICP.


Trouble shooting for GC


Recognized as a certified analyst through proficiency testing, verifying reliability and accuracy in highly delicate, micro-level analytical testing

Cosmetic Product Analyst (Contract)

KTR (Korea Testing & Research Institute)
12.2020 - 03.2021

Analyzed harmful substances in cosmetic products using GC/FID, GC/MS, mercury analyzers.


Maintained LIMS records and conducted quality documentation processes.

Education

B.S. in Biochemical Engineering - Biochemical Engineering

Korea Polytechnic University
Siheung
08-2020

Skills

  • Laboratory techniques
  • Validation
  • Data integrity
  • Scheduling
  • Instrument Calibration
  • Purchasing consumable
  • Team-work
  • Health and Safety Management

Certification

  • Certified Industrial Hygienist (Qualified as Health Manager)
  • Hazardous Materials Industrial Engineer License
  • OPIc (English) – IH Level

Timeline

QC Analyst

Kenvue Korea
11.2024 - Current

Quality Control Specialist

Hwaeil Pharmaceutical Co.Ltd.
02.2022 - 04.2024

Analytical Chemist (Contract)

Korea University Ansan Hospital
06.2021 - 12.2021

Cosmetic Product Analyst (Contract)

KTR (Korea Testing & Research Institute)
12.2020 - 03.2021

B.S. in Biochemical Engineering - Biochemical Engineering

Korea Polytechnic University
Jeonghye Shin