QA Associate – Quality Assurance (Full-time, Pomona)

About the role

The QA Associate will work under the QA Manager in a GMP environment, supporting product release, change control, and continuous improvement initiatives. This role focuses on modernizing quality systems and driving data‑driven, risk‑based decisions.

Key responsibilities

• Conduct Annual Product Reviews (APRs) and prepare summary reports with quality metrics.
• Review batch records, determine disposition, and support risk‑based electronic batch record reviews.
• Provide oversight and approval for CAPA, deviation, and change control processes.
• Lead change control initiatives and manage documentation workflows in the e‑QMS.
• Administer GMP documents and quality records within ZenQMS.
• Investigate product complaints, deviations, and OOS results to identify root causes and corrective actions.
• Perform internal QA audits on manufacturing lines and finished products.
• Participate in regulatory, customer, and internal/mock audits and track corrective action effectiveness.
• Support implementation and adoption of e‑QMS, LIMS, and electronic batch records.

Required profile

• Experience working in a GMP‑regulated environment.
• Familiarity with electronic quality systems such as e‑QMS, LIMS, and electronic batch records.
• Ability to conduct root‑cause investigations and manage CAPA processes.

Required skills

• e‑QMS (ZenQMS) administration
• LIMS usage
• Electronic batch record (EBR) review
• GMP documentation management
• Root cause analysis
• CAPA management