QA Associate: Drive QMS & GMP Compliance

CTK USA INC; Corona (CA); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Health Insurance

Paid Time Off

Paid holidays

Floating holiday

Job summary

CTK OTC Laboratories in Corona, CA is hiring a Quality Assurance Associate to support the daily operation of our quality management system. You will handle change control, deviation and nonconformance documentation, batch record review, supplier audit support, and training records under supervision of the QA Manager.

The role emphasizes documentation accuracy, data integrity, and collaboration with Production, QC, and Warehouse teams. A Bachelor’s degree and cGMP experience are preferred.

Qualifications

• Bachelor's degree preferred.
• QA documentation in a cGMP-regulated environment.
• Experience preparing deviation, NCR, or change control documentation preferred.
• Batch record review experience strongly preferred.

Responsibilities

• Support 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 at reviewer level; final approval by QA Manager.
• Support complaint investigations and coordinate complaint sample testing with QC.
• Coordinate pest control program review of vendor visits and trap logs.
• Support internal audits, Mock Recall exercises, and Annual Product Review data compilation.
• Maintain quality records per ALCOA+ and data integrity requirements.

Skills

cGMP knowledge

ALCOA+ documentation

Investigation writing

Attention to detail

Record management

Cross-team communication

Bilingual (English/Korean)

Education

Bachelor's degree

Tools

MS Word

Excel

Outlook

PDF tools

Job description

CTK OTC Laboratories in Corona, CA is hiring a Quality Assurance Associate to support the daily operation of our quality management system. You will handle change control, deviation and nonconformance documentation, batch record review, supplier audit support, and training records under supervision of the QA Manager.

The role emphasizes documentation accuracy, data integrity, and collaboration with Production, QC, and Warehouse teams. A Bachelor’s degree and cGMP experience are preferred.