QA Specialist II at RadGov Inc. in Potomac, Maryland

QA Specialist II

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:

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 scope 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.

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., Track Wise, EDMS systems, SAP) preferred.