Lead QA Specialist - Supplier Audits
Meet Life Sciences, California, Missouri, United States, 65018
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.
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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.
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