QA Specialist II

Job Description

Job Summary:

• The QA Specialist II – Supplier Quality Management and Quality Systems will support in the development and maintenance of quality systems for the management of suppliers that provide critical and controlled materials for GMP-related operations and inspection readiness.
• This includes but is not limited to the following:

Duties and Responsibilities:

• 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.
• Complete assessments of new suppliers and changes to Product of work for approved suppliers.
• Review the material specifications for their conformance to internally established procedures.
• Lead the risk assessment process for vendor classification.
• Review and maintain vendor qualification associated documentation.
• Serve as the lead auditor during the vendor qualification process.
• 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.
• Additional duties as assigned.

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.