QC Lab Manager – OTC Drugs & Cosmetics

CTK USA INC; Corona (CA); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Health Insurance

Paid Time Off (PTO)

Paid holidays

Annual floating holiday

Job summary

CTK OTC Laboratories in California seeks an experienced Quality Control Manager to lead the QC lab operations for OTC drug and cosmetic products. You will supervise technicians, oversee testing and stability, ensure data integrity, and drive investigations for OOS/OOT results in compliance with 21 CFR 210/211 and FDA guidance.

You will report to the QD Director, manage instrument calibration, and maintain reference standards while promoting accurate documentation and timely release of materials.

Qualifications

• Bachelor's degree in a relevant science field and hands-on QC lab experience in a cGMP-regulated environment.
• Experience leading OOS investigations and preparing investigation reports.
• Proficiency with analytical instruments and method validation/verification.
• Ability to author and review specifications, test methods, and investigations in English.
• Experience in data integrity remediation and audit trail review preferred.

Responsibilities

• Lead QC laboratory operations for physicochemical and microbiological testing.
• Supervise QC Laboratory Technicians and Package Incoming Inspector; manage training.
• Oversee stability program, environmental monitoring, and data integrity (ALCOA+).
• Review results, determine conformance, and report to QA for disposition.
• Lead Phase I OOS/OOT investigations and support Phase II investigations.
• Ensure compliance with 21 CFR Parts 210, 211, FDA OOS Guidance, and Part 11.

Skills

Regulatory knowledge

Data analysis

Technical writing

Supervisory/training

Bilingual (EN/Korean or EN/Spanish)

Education

Bachelor's degree in Chemistry/Pharmacy/Pharmaceutical Sciences/Microbiology/Biology/Chemical Engineering

Tools

HPLC/UPLC

GC

UV-Vis

FTIR

Karl Fischer

Viscometer

Wet chemistry methods

Job description

CTK OTC Laboratories in California seeks an experienced Quality Control Manager to lead the QC lab operations for OTC drug and cosmetic products. You will supervise technicians, oversee testing and stability, ensure data integrity, and drive investigations for OOS/OOT results in compliance with 21 CFR 210/211 and FDA guidance.

You will report to the QD Director, manage instrument calibration, and maintain reference standards while promoting accurate documentation and timely release of materials.