QA Associate - QMS & Documentation Specialist

CTK USA INC; Corona (CA); On-site; USD 65,000 - 85,000; Full time

Benefits offered by this job

Health Insurance

PTO

Paid holidays

Floating holiday

Job summary

CTK OTC Laboratories seeks a Quality Assurance Associate to support daily QMS activities and document control in a cGMP setting. You will handle deviation, NCR, and change control tasks, with reviewer-level batch record reviews under supervision.

You will also assist with supplier audits, training records, and pest-control coordination while ensuring ALCOA+ data integrity and clear English investigations. This role reports to the QA Manager and requires strong detail orientation.

Qualifications

• Experience in a cGMP-regulated environment (OTC drug, pharmaceutical, cosmetic, medical device, or food).
• Ability to write clear, factual investigation narratives in English.
• Experience preparing deviation, NCR, or change control documentation.
• Batch record review experience is strongly preferred.

Responsibilities

• Support operation and maintenance of the quality management system (QMS).
• Initiate change control requests and track actions to closure.
• Conduct deviation investigations and prepare deviation reports for QA Manager review.
• Prepare and manage nonconformance reports (NCR).
• Support supplier audits, including 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 by QA Manager.
• Support complaint investigations and coordinate sample testing with QC.
• Coordinate pest control program reviews and vendor visit logs.
• Support internal audits, Mock Recalls, and Annual Product Review data compilation.
• Maintain all quality records per ALCOA+ requirements.

Skills

cGMP knowledge

ALCOA+

Documentation writing

Detail oriented

Multi-record management

Communication

Bilingual EN/Korean

Education

Bachelor's degree preferred

Quality assurance in cGMP

Deviation/NCR/change control docs

Batch record review experience

Tools

Microsoft Word

Excel

Outlook

PDF tools

E-document systems

Job description

CTK OTC Laboratories seeks a Quality Assurance Associate to support daily QMS activities and document control in a cGMP setting. You will handle deviation, NCR, and change control tasks, with reviewer-level batch record reviews under supervision.

You will also assist with supplier audits, training records, and pest-control coordination while ensuring ALCOA+ data integrity and clear English investigations. This role reports to the QA Manager and requires strong detail orientation.