QC Laboratory Technician (RM-Water)

Job Description

Job Description

About the Role

CTK OTC Laboratories is seeking a QC Laboratory Technician (Raw Material / Water & Visual Inspection) 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 sensory and visual inspection in accordance with approved specifications
• Perform purified water sampling and water quality testing, and record monitoring results
• Execute incoming raw material testing, record test results, and prepare CoA documentation
• Manage reference standards and reagents, including receipt, labeling, expiration control, and storage
• Manage raw material retain samples, including labeling, storage condition control, and inventory
• Perform Daily Verification of assigned instruments (e.g., viscometer, refractometer, microbiological equipment) and record results contemporaneously
• Support tamper-evident packaging inspection (21 CFR 211.132) as assigned
• 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 or incoming-material testing experience in a cGMP-regulated environment (OTC drug, pharmaceutical, cosmetic, or dietary supplement)
• Experience with water quality testing (conductivity, TOC, microbial limits) preferred
• Experience with raw material identity and conformance testing is an advantage
  

Knowledge, Skills & Abilities

• Working knowledge of cGMP laboratory and component controls (21 CFR 211.84, 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
• Proficiency in sensory/visual inspection techniques and use of basic laboratory instrumentation
• Strong attention to detail and legible, contemporaneous documentation
• Bilingual English/Korean or English/Spanish is a plus
  

Regulatory Scope

This position performs raw material, water, and sensory/visual testing supporting compliance with component controls (21 CFR 211.84), laboratory controls (211.160–211.167), and tamper-evident packaging inspection (211.132). Technical conformance is determined by the QC Manager, with final material disposition granted by QA.

Benefits

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