QA Specialist II

Key Responsibilities And Duties

• Conduct supplier audits worldwide, write the relevant audit reports, and keep the suppliers' CAPA monitored to ensure compliance with the applicable regulations.
• Participate in due diligence of new suppliers/projects as applicable to quality-related aspects.
• Ensure that Management is informed of critical findings resulting from supplier audits.
• Support the Quality Assurance Department when major and critical issues occur with the suppliers of materials and GXP-related services and, when needed, carry out "for-cause" audits.
• Support the Global Supply Chain with the introduction of new suppliers.
• Begin and complete the initial qualification, requalification, and discontinuation requirements of suppliers.
• Ensure that the material specifications for their conformance to internally established procedures are reviewed.
• Lead the risk assessment process for vendor classification.
• Review and maintain vendor qualification associated documentation.
• Lead the vendor qualification process and serve as the lead auditor.
• Provide information to end users (stakeholders) on the vendor qualification status on a monthly basis.
• Participate in the global vendor qualification process and serve as the committee site representative.
• Prepare annual vendor performance report and maintain QA vendor file.
• Support client and regulatory authorities and provide the necessary information to answer questions related to supplier management.
• Manage the Quality Agreements with suppliers of critical materials and GXP-related services.
• Manage the supplier-related software and supplier databases.
• Perform the annual assessment of suppliers and write the supplier status certificates.
• Review the Material Specification and Disposition documents upon initiation or revision.
• Establish and maintain Investigation, Deviation, CAPA, Effectiveness Verification systems, and internal and external audit.
• Provide oversight and guidance to ensure timely and compliant execution of quality records.
• Perform trending, risk assessments, and report key quality metrics to management and QMR.
• Evaluate CAPA effectiveness and identify systemic improvements.
• Oversee supplier qualification, audits, and performance monitoring.
• Manage supplier quality issues, escalation, and quality agreements.
• Conduct supplier audits and ensure CAPA effectiveness.
• Drive continuous improvement and ensure regulatory compliance (FDA, EMA, ICH).
• Support audits, inspections, and inspection readiness activities.
• Collaborate cross-functionally to maintain quality and compliance standards.
• Participate in recruiting, training, and mentoring activities.

Qualifications

• BS/BA in Life Sciences or related field.
• Minimum 5 years GMP experience in pharmaceutical/biopharmaceutical industry.
• Experience in Quality Systems and Supplier Quality Management.
• Strong knowledge of GMP regulations and quality systems.
• Excellent communication, organizational, and analytical skills.
• Experience with electronic quality systems (e.g., TrackWise, EDMS systems, SAP) preferred.