QC Laboratory Technician (FP-IPC)

Job Description

Job Description

About the Role

CTK OTC Laboratories is seeking a QC Laboratory Technician (Finished Product / In-Process Testing) to perform incoming raw material testing, purified water sampling and water quality testing, and finished product sensory and visual inspection. In this role, you'll prepare test result records and CoA documentation to support quality decisions made by the QC Manager and QA.

What You'll Do

• Perform finished product and bulk physicochemical testing in accordance with approved test methods and specifications
• Perform in-process inspection testing and report results promptly to the QC Manager
• Schedule stability testing and issue stability test requisitions per the approved stability protocol
• Coordinate laboratory instrument calibration and maintenance, including scheduling and record retention
• Perform Daily Verification of assigned chemistry instruments (e.g., HPLC, analytical balance, pH meter) and record results contemporaneously
• Manage bulk and finished product retain samples, including labeling, storage condition control, and inventory
• Report atypical, out-of-trend, or out-of-specification results immediately to the QC Manager and support Phase I laboratory investigations
• Maintain laboratory cleanliness, reagent labeling, and safe handling of chemicals per procedures
• Record all test data contemporaneously and accurately in compliance with Good Documentation Practices and data integrity (ALCOA+) requirements
  

Education & Experience

• Bachelor's Degree preferred
• Practical QC laboratory testing experience in a cGMP-regulated environment (OTC drug, pharmaceutical, cosmetic, or dietary supplement)
• Hands-on experience with analytical instrumentation (HPLC, analytical balance, pH meter, viscometer) preferred
• Experience supporting a stability program is an advantage
  

Knowledge, Skills & Abilities

• Working knowledge of cGMP laboratory controls (21 CFR 211.160–211.167) and Good Documentation Practices (ALCOA+)
• Ability to follow approved test methods precisely and perform accurate calculations and unit conversions
• Competent with Microsoft Word, Excel, Outlook, PDF tools, and electronic document/record and inventory systems
• Ability to operate and troubleshoot routine laboratory instrumentation
• Strong attention to detail and legible, contemporaneous documentation
• Bilingual English/Korean or English/Spanish is a plus
  

Regulatory Scope

This position performs finished product, bulk, and in-process testing under approved test methods, supporting compliance with laboratory controls (21 CFR 211.160–211.167) and stability testing (211.166). All results are reviewed by the QC Manager, and atypical or out-of-specification results are escalated immediately.

Benefits

• Health Insurance — premium 100% covered by employer for the employee
• Paid Time Off (PTO)
• Paid holidays
• Annual floating holiday