Quality Assurance Specialist

Requirements - GC holder or USC required Overview We are recruiting for a long-term contract Vendor Quality & Compliance Specialist to be responsible for supporting vendor and material qualification activities for our client's Hopewell site in accordance with established procedures and applicable quality and regulatory requirements. This role manages the site Approved Vendor List (AVL), vendor reassessments, supplier change notifications, material qualification activities, and related change controls and quality documentation. The position works closely with Internal Supply Quality, External Supply Quality, Global Quality Compliance, Legal, business stakeholders, and external vendors to ensure supplier lifecycle activities remain compliant, well documented, and inspection ready. The role also provides critical support for regulatory and customer inspection readiness, including FDA inspection preparation and audit backroom activities. Responsibilities Lead the qualification of new vendors and materials for the Hopewell site in accordance with established procedures and applicable quality requirements. Maintain, update, and ensure the accuracy and integrity of the site Approved Vendor List (AVL). Track, monitor, and complete periodic vendor reassessments to ensure ongoing supplier compliance and approval. Manage vendor reassessment schedules, documentation, follow‑ups, and completion tracking to support effective supplier lifecycle oversight. Ensure required BSE/TSE evaluations are obtained and maintained for all materials used in manufacturing. Monitor supplier change notifications and initiate required site documentation and assessments. Initiate, own, and support change controls associated with supplier changes, vendor qualification, and material qualification. Assist business users with the creation, routing, and completion of change controls required for vendor and material qualification activities. Assess and elevate supplier changes as appropriate based on business impact, quality risk, and procedural requirements. Partner with Internal Supply Quality, External Supply Quality, Legal, and vendors to generate, review, and route Quality Assurance Agreements for approval. Work with Global Quality Compliance to request and coordinate vendor audits as needed for vendor qualification. Collaborate with External Supply Quality to qualify and reassess shared vendors across multiple sites. Provide critical support for pre‑approval inspection readiness, including FDA inspection preparation activities. Ensure vendor management, change management, and material qualification processes and documentation remain inspection ready. Participate in regulatory inspections and audit backroom activities as required. Review and identify opportunities to improve vendor management, qualification, and reassessment processes to strengthen compliance and inspection readiness. Provide day-to-day support for business needs related to vendor quality and compliance. Maintain accurate, complete, and timely quality records and documentation in accordance with applicable procedures and regulatory expectations. Effectively communicate status, risks, issues, and escalations to relevant stakeholders. Requirements: Bachelor’s degree in Life Sciences, Chemistry, Biology, Engineering, Quality Assurance, Regulatory Affairs, or a related discipline required, with at least two years of relevant experience. Equivalent combination of education and relevant experience in a regulated pharmaceutical, biotechnology, or manufacturing environment may be considered. Experience in Quality Assurance, Quality Compliance, Vendor Quality, Supplier Quality, or a related function within a regulated pharmaceutical, biotechnology, or manufacturing environment. Knowledge of vendor qualification, material qualification, supplier change management, Quality Assurance Agreements, and change control processes. Familiarity with regulatory inspection readiness activities and support for FDA or other regulatory inspections. Strong understanding of quality systems, documentation practices, and compliance expectations in a regulated environment. Strong cross‑functional collaboration, communication, organizational, and documentation skills. Demonstrated ability to manage multiple priorities, timelines, and stakeholders in a fast‑paced, highly regulated environment. Strong attention to detail and ability to identify compliance risks, gaps, and opportunities for process improvement. Ability to work independently while effectively partnering with cross‑functional teams and external suppliers. #J-18808-Ljbffr