QA Jobs in Orange, CA

Leads QA Operations for deviations, CAPA, OOS, and complaints supporting biopharmaceutical manufacturing. Oversees quality event review and approval, cGMP compliance, analytics and KPI trending, root-cause investigations, preventive actions, and continuous improvement. Manages and develops Quality personnel, provides real-time manufacturing-floor oversight, supports client issue resolution, and partners with Operations and centralized Quality Systems teams.

Conducts internal and external cGMP audits, reviews quality and vendor documentation, manages corrective actions and supplier discrepancies, supports regulatory inspections, evaluates compliance changes, writes SOPs, approves quality records, and implements process improvements. Serves as a quality compliance subject matter expert, mentors junior staff, monitors metrics, and advises internal and external stakeholders. Occasional overnight travel by land or air is required.

Perform operational quality assurance for deposit products: review audit reports, complete product/fee changes, validate approvals, maintain client data integrity, perform audits, ensure regulatory compliance, and participate in compliance training.

Manage and mentor a team of QA engineers, defining testing strategies and improving processes for fintech products, ensuring quality and compliance.