QC Manager

CTK USA INC•Corona, CA

12d

About The Position

CTK OTC Laboratories is seeking an experienced Quality Control Manager to lead our QC laboratory operations for OTC monograph drug and cosmetic products. Reporting to the QD Director, you will oversee physicochemical and microbiological testing, the stability program, environmental monitoring execution, and laboratory data integrity. You will determine technical conformance of tested materials, lead Phase I laboratory investigations of OOS/OOT results, and develop specifications and analytical methods — all in compliance with 21 CFR 210/211 and FDA OOS Guidance. You will directly supervise the QC Laboratory Technicians and the Package Incoming Inspector, and own the day-to-day performance of the QC laboratory.

Requirements

Substantial hands-on QC laboratory experience in a cGMP-regulated environment (OTC drug, pharmaceutical, cosmetic, or dietary supplement), including supervisory or managerial experience
Demonstrated experience with analytical instrumentation (HPLC/UPLC, GC, UV-Vis, FTIR, Karl Fischer, viscometer) and wet chemistry methods
Demonstrated experience with method validation/verification, stability program operation, and microbial limit testing
Experience leading Phase I laboratory OOS investigations and preparing investigation reports
Thorough working knowledge of 21 CFR Parts 210, 211, and 11, USP general chapters, and FDA OOS Guidance
Ability to critically evaluate analytical data and distinguish laboratory error from manufacturing-related causes
Ability to author and review specifications, test methods, validation protocols, and investigation reports in English
Competent with Microsoft Word, Excel, Outlook, PDF tools, and electronic document/record and inventory systems
Proficiency with chromatographic data systems and laboratory electronic records, including audit trail review
Effective supervisory and training skills for laboratory personnel

Nice To Haves

Bachelor's degree in Chemistry, Pharmacy, Pharmaceutical Sciences, Microbiology, Biology, Chemical Engineering preferred but not required
Experience with laboratory data integrity remediation and audit trail review preferred
Bilingual English/Korean or English/Spanish is a plus

Responsibilities

Manage physicochemical testing of raw materials, in-process materials, and finished products, and perform first-level review of results
Manage microbial limit testing and environmental monitoring (EM) execution
Determine technical conformance of raw materials, packaging components, and in-process materials, and report results to QA for disposition
Operate the stability testing program, manage stability results, and recommend expiration dating
Develop specifications and technical justifications for raw materials, in-process materials, finished products, and purified water for QA approval
Execute and technically review analytical method validation protocols and reports
Lead OOS/OOT Phase I laboratory investigations and support QA-led Phase II investigations
Perform first-level review of electronic data audit trails and oversee laboratory system CSV
Manage laboratory instrument calibration, maintenance, and the Daily Verification program
Oversee reference standards, reagents, and retain sample management
Manage purified water testing and monitoring, and monitor storage/stability chamber conditions
Execute tamper-evident packaging inspection (21 CFR 211.132) and testing/quality evaluation of returned and recalled products
Manage laboratory data integrity (ALCOA+) compliance and provide trend data for the Annual Product Review
Directly supervise, train, and evaluate the QC Laboratory Technicians and the Package Incoming Inspector
Develop and manage QC test method, instrument, and laboratory job-specific training programs (new-hire and periodic refresher)
Set day-to-day priorities and workload across the QC laboratory to meet testing and release timelines
Build a strong laboratory culture of accurate, contemporaneous documentation and prompt escalation of atypical results