QA Associate

Job Description

Job Description

About the Role

CTK OTC Laboratories is seeking a Quality Assurance Associate to support day-to-day operation of our quality management system. In this role, you'll handle change control, deviation and nonconformance documentation, reviewer-level batch record GMP compliance review, supplier audit support, training record management, and the pest control program. You'll prepare quality documentation for review and approval by the QA Manager and will not hold independent approval authority.

What You'll Do

• Support the operation and maintenance of the quality management system (QMS)
• Initiate change control requests and track implementation actions to closure
• Conduct deviation investigations and prepare deviation reports for QA Manager review and approval
• Prepare and manage nonconformance reports (NCR)
• Support supplier audits, including preparation of audit packages, questionnaires, and follow-up tracking
• Manage training records and monitor training completion status
• Perform batch record GMP compliance review (21 CFR 211.192) at reviewer level; final approval is granted by the QA Manager
• Support complaint investigations and coordinate complaint sample testing with QC
• Coordinate and monitor the pest control program, including review of vendor visit reports and trap logs
• Support internal audits, Mock Recall exercises, and Annual Product Review data compilation as assigned
• Maintain all quality records in accordance with Good Documentation Practices and data integrity (ALCOA+) requirements
  

Education & Experience

• Bachelor's Degree preferred
• Practical quality assurance or quality documentation experience in a cGMP-regulated environment (OTC drug, pharmaceutical, cosmetic, medical device, or food)
• Experience preparing deviation, NCR, or change control documentation preferred
• Experience performing batch record review strongly preferred
  

Knowledge, Skills & Abilities

• Working knowledge of cGMP requirements (21 CFR 210/211) and Good Documentation Practices (ALCOA+)
• Ability to write clear, factual investigation narratives in English
• Competent with Microsoft Word, Excel, Outlook, PDF tools, and electronic document/record and inventory systems
• Strong attention to detail and ability to identify documentation discrepancies
• Ability to manage multiple open records and meet due dates without prompting
• Effective communication with Production, Warehouse, and QC personnel
• Bilingual English/Korean or English/Spanish is a plus
  

Regulatory Scope

This position supports the QA Manager in maintaining compliance with the quality management system, including reviewer-level batch record review under 21 CFR 211.192, deviation and nonconformance documentation, change control, and data integrity (ALCOA+) requirements. Final approval authority for all quality records rests with the QA Manager.

Benefits

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