Sr. QA Specialist, Supplier Audit

POSITION SUMMARY:

Responsible for planning and conducting supplier audits, coordinating corrective actions, and supporting supplier qualification processes. Responsible for leading Vendor Change Notification (VCN) processes, supporting quality agreement programs including periodic reviews and documentation, and collaborating cross-functionally with QC, Facilities, Validation and Manufacturing departments to resolve compliance issues.

PRINCIPAL DUTIES: 

• Plan, schedule, and conduct supplier audits to assess compliance with applicable regulatory requirements.
• Oversee aspects of the vendor qualification program, including maintaining approved supplier documentation and records in the quality management system.
• Evaluate audit findings, determine risk levels, and monitor the implementation of corrective and preventive actions.
• Manage corrective action request programs related to supplier and audit findings.
• Responsible for leading Vendor Change Notification (VCN) processes.
• Generate and review supplier quality agreements, as needed.
• Maintain and organize documentation related to audits, vendors, and compliance activities in the quality system.
• Participate in audit-related reporting and present key audit metrics to quality leadership.
• Collaborate with various departments to support quality and compliance functions across operations.
• Assist in preparation for regulatory inspections and internal readiness initiatives.
• Assist in the implementation of corrective and preventive actions (CAPAs) across departments when needed.
• Perform additional duties in support of overall quality and compliance goals.
• Excellent knowledge of quality control standards and testing methodologies.
• Assist with the investigation and closure of non-conformances, as needed, ensuring appropriate corrective and preventive actions (CAPA) and change controls are initiated and deviations are closed.
• Author, review and approve standard operating procedures (SOPs), as needed, in alignment with quality standards and regulatory guidelines.

JOB REQUIREMENTS

• Proven track record of conducting supplier audits and driving quality improvement initiatives.
• Exceptional communication and interpersonal skills to effectively manage supplier relationships.
• Strong organizational skills and attention to detail in managing multiple projects.
• A proactive mindset with a commitment to continuous improvement.
• Strong interpersonal skills and demonstrated ability to work collaboratively in a team-oriented environment.
• Self-motivated with the ability to manage multiple tasks and meet deadlines.
• Adaptable to changing priorities and able to thrive in a fast-paced dynamic environment, while maintaining quality standards.

EDUCATION AND/OR EXPERIENCE

• 8 years of relevant work experience in quality management, with a focus on supplier quality in a pharmaceutical manufacturing environment.
• Minimum 5 years of Supplier Quality experience required.
• 5 years of Internal Audits experience. Quality Auditor Certification (e.g., ASQ, CQE) preferred.

• Proficiency in Microsoft Office Suite: Strong knowledge of Word, Excel, PowerPoint, Access, and Outlook.
• Bachelor’s degree in chemistry, biochemistry, or related field.