Quality Assurance Specialist – Supplier Quality

Supplier Quality Specialist

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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

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

• 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

• 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 quality and compliance

Experience Level: Mid-Level (2-5 Years)

Job Type &

Location:

This is a Contract to Hire position based out of Framingham, MA.

Pay and Benefits:

The pay range for this position is $38.00 - $40.00/hr individual compensation offered for this position within…