QA Associate

CTK USA INC•Corona, CA

1d•$18 - $26

About The Position

CTK OTC Laboratories is seeking a Quality Assurance Associate to support the day-to-day operation and maintenance of its quality management system. The role handles change control, deviation and nonconformance documentation, reviewer-level GMP batch record compliance review, supplier audit support, training record management, and the pest control program. The Associate prepares quality documentation for review and approval by the QA Manager and does not have independent approval authority. The position also supports complaint investigations, internal audits, Mock Recall exercises, and Annual Product Review data compilation as assigned, while maintaining quality records in accordance with Good Documentation Practices and ALCOA+ data integrity requirements.

Requirements

Practical quality assurance or quality documentation experience in a cGMP-regulated environment, such as OTC drugs, pharmaceuticals, cosmetics, medical devices, or food.
Working knowledge of cGMP requirements under 21 CFR 210/211 and Good Documentation Practices (ALCOA+).
Ability to write clear, factual investigation narratives in English.
Competence 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.

Nice To Haves

Bachelor's degree preferred.
Experience preparing deviation, NCR, or change control documentation preferred.
Experience performing batch record review strongly preferred.
Bilingual English/Korean or English/Spanish is a plus.

Responsibilities

Support operation and maintenance of the quality management system (QMS).
Initiate change control requests and track implementation actions through closure.
Conduct deviation investigations and prepare reports for QA Manager review and approval.
Prepare and manage nonconformance reports (NCRs).
Support supplier audits by preparing audit packages and questionnaires and tracking follow-up actions.
Manage training records and monitor training completion status.
Perform reviewer-level batch record GMP compliance review under 21 CFR 211.192; 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 reviewing vendor visit reports and trap logs.
Support internal audits, Mock Recall exercises, and Annual Product Review data compilation as assigned.
Maintain quality records in accordance with Good Documentation Practices and ALCOA+ data integrity requirements.