Quality Assurance Specialist – Supplier Quality

Supplier Quality Specialist Position Overview We are seeking a detail-oriented Supplier Quality Specialist to support supplier qualification, compliance, and quality management activities within a regulated manufacturing environment. This individual will partner with internal and external stakeholders to ensure suppliers meet quality, regulatory, and operational requirements while driving continuous improvement initiatives throughout the supplier lifecycle.

Key Responsibilities Supplier Qualification & Management Support the qualification, onboarding, and ongoing management of suppliers, vendors, and service providers. Maintain supplier qualification records, quality agreements, and associated compliance documentation. Coordinate supplier approval activities and periodic performance evaluations. Assist with supplier risk assessments and supplier lifecycle management activities.

Supplier Quality & Compliance Review supplier quality documentation, audit reports, and corrective action responses. Participate in supplier audits, assessments, and quality reviews. Monitor supplier performance metrics and support continuous supplier improvement initiatives. Ensure supplier activities align with applicable quality standards, regulatory requirements, and internal procedures. Change Control & Risk Management Manage supplier communications related to quality events, changes, and notifications.

Coordinate cross-functional impact assessments for supplier-related changes. Support implementation and documentation of supplier change control activities. Assist with risk assessments and mitigation strategies associated with supplier quality and supply continuity. CAPA & Issue Resolution Track supplier quality events, investigations, and corrective and preventive actions (CAPAs). Partner with suppliers and internal teams to address nonconformances and quality concerns.

Monitor action item completion and ensure timely closure of quality-related commitments. Support root cause investigations and effectiveness assessments. Cross-Functional Collaboration Collaborate with Quality, Manufacturing, Supply Chain, Procurement, Operations, and Technical teams. Provide support for inspections, audits, and regulatory readiness activities. Contribute to continuous improvement projects focused on supplier quality systems and operational excellence.

Required Qualifications Education Bachelor's degree in Chemistry, Biology, Food Science, Engineering, Life Sciences, or a related technical discipline. Equivalent combination of education and relevant industry experience will be considered. Experience 2-5 years of experience in quality assurance, supplier quality, manufacturing, or a regulated industry environment. Experience supporting supplier qualification, supplier audits, performance monitoring, CAPA management, and change control processes.

Prior experience working within GMP, GxP, FDA-regulated, pharmaceutical, biotechnology, medical device, food manufacturing, or advanced manufacturing environments preferred. Experience participating in internal, external, or supplier audits. Technical Knowledge Working knowledge of: Supplier Quality Management Systems GMP/GxP regulations and quality standards CAPA and deviation management Risk assessment methodologies Change control processes Audit readiness and compliance programs Quality documentation and data management systems Preferred Skills Supplier Quality Management Vendor Qualification Supplier Audits GMP / GxP Compliance CAPA Management Change Control Risk Assessment Root Cause Investigation Quality Systems Continuous Improvement Quality Assurance Regulatory Compliance Desired Competencies Strong organizational and project management skills Excellent written and verbal communication abilities Ability to manage multiple priorities in a fast-paced environment Strong problem-solving and analytical capabilities Proven ability to work effectively across cross-functional teams Detail-oriented with a commitment to quali