Quality Assurance Associate - Supplier Management

Your Role

Quality Assurance Associate - Supplier Management

Responsibilities

• Manage quality assurance activities related to material movement, including disposition, hold, rejection, and release of incoming materials.
• Support Manufacturing and Warehouse teams by promoting compliance through leadership, collaboration, and day-to-day quality oversight.
• Own the lifecycle management of material and packaging specifications, including drafting, annual review, and revision updates.
• Conduct gap assessments for material, packaging, labeling specifications, and Standard Operating Procedures (SOPs).
• Draft, route, and complete quality system records including change controls, deviations, CAPAs, and investigations within the Veeva Quality Management System.
• Participate in and lead internal and supplier audits while supporting documentation requests for external regulatory audits.
• Analyze quality events, investigations, and projects to determine appropriate actions and independently resolve complex technical and compliance issues.
• Represent Quality Assurance on cross-functional project teams and provide quality guidance to support business objectives.
• Author and revise quality documents, procedures, and records to maintain compliance with applicable regulations and internal standards.
• Conduct SAP transactions to support material release activities and verify data accuracy within the system.
• Support records management and archival activities while assisting other Quality Assurance team members as needed.

Requirements

• Education: Bachelor's degree in a Life Science discipline preferred, or equivalent combination of education and experience.
• Experience: Minimum of 5 years of experience in a regulated industry (USDA, FDA, ISO, GMP, or similar) with direct Quality Assurance experience.
• Strong understanding of quality systems, GMP principles, and applicable regulatory requirements.
• Experience reviewing and approving quality documentation, investigations, deviations, CAPAs, and change controls.
• Demonstrated ability to make sound independent decisions and manage multiple priorities simultaneously.
• Strong technical writing, analytical, and problem-solving skills.
• Excellent verbal and written communication skills.
• Proficiency with Microsoft Office applications including Word, Excel, and PowerPoint.
• Able to work effectively in a collaborative team environment.