QA Associate — QMS & GMP Compliance Specialist

CTK USA INC; Corona (CA); On-site; USD 70,000 - 90,000; 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 the day-to-day operation of our quality management system. You will handle change control, deviation and nonconformance documentation, and reviewer-level batch record GMP reviews with final approval by the QA Manager.

Responsibilities include supplier audits support, training record management, pest control coordination, and assisting internal audits and recalls. A cGMP background and strong documentation skills are essential.

Qualifications

• Bachelor's degree preferred in a relevant field.
• Practical QA 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.

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.
• Prepare and manage nonconformance reports (NCR).
• Support supplier audits, including preparation of audit packages and questionnaires.
• Manage training records and monitor training completion status.
• Perform batch record GMP compliance review at reviewer level; final approval by QA Manager.
• Coordinate complaint testing with QC and assist investigations.
• Coordinate pest control program reviews and vendor visit reports.

Skills

cGMP knowledge

Investigation writing (English)

Documentation accuracy

Cross-functional communication

Education

Bachelor's degree

Tools

Microsoft Word

Microsoft Excel

Outlook

PDF tools

Job description

CTK OTC Laboratories seeks a Quality Assurance Associate to support the day-to-day operation of our quality management system. You will handle change control, deviation and nonconformance documentation, and reviewer-level batch record GMP reviews with final approval by the QA Manager.

Responsibilities include supplier audits support, training record management, pest control coordination, and assisting internal audits and recalls. A cGMP background and strong documentation skills are essential.