Sr. QA Specialist - Supplier Audits

A growing pharmaceutical manufacturer based in Orange County, CA is seeking a Lead Quality Assurance Specialist to join their team! This Lead QA Specialist will eventually grow into a QA Supervisor role and manage a team of 5. This individual will be responsible for planning and conducting supplier audits, coordinating corrective actions, and supporting supplier qualification processes. This position is required to work onsite 5 days/week.

Role Responsibilities:

• Plan and conduct internal and supplier audits to ensure compliance with regulatory requirements.
• Manage supplier quality processes, including quality agreements, vendor qualification, approved supplier documentation, and coordination of third-party audits.
• Oversee corrective action programs (CAPA), audit findings, nonconformances, and change controls to ensure timely resolution and risk mitigation.
• Maintain audit, vendor, and compliance documentation within the quality management system (QMS).
• Evaluate audit results, assess risk levels, and track implementation of corrective and preventive actions.
• Support regulatory inspection readiness and internal compliance initiatives.
• Review laboratory data for accuracy, completeness, and regulatory compliance.
• Author, review, and approve SOPs in alignment with quality standards and regulatory requirements.
• Collaborate cross-functionally to support overall quality assurance and compliance objectives.

Required Skills/Experience:

• Bachelor's Degree in biochemistry, chemistry, or related.
• 5+ years of supplier quality experience in a pharmaceutical manufacturing environment.
• 5+ years of experience leading Supplier Audits and Internal Audits.
• Quality Auditor Certification (e.g., ASQ, CQE) preferred.