Pay 40-50/h depending on experience Lead qualification of new vendors and materials for the Hopewell site in accordance with established procedures. Maintain, update, and ensure accuracy of the site Approved Vendor List. Track, monitor, and complete periodic vendor reassessments to ensure ongoing compliance. Manage periodic reassessment schedules, documentation, follow-ups, and completion tracking to support supplier lifecycle oversight and continued vendor approval. Ensure required BSE/TSE evaluations are obtained for all materials used in manufacturing. Monitor supplier change notifications and initiate required site documentation as needed. Initiate, own, and support change controls associated with supplier changes, vendor qualification, and material qualification. Assist business users with creating and routing change controls required for vendor and material qualification. Escalate supplier changes as appropriate based on business impact and procedural requirements. Partner with Internal Supply Quality, External Supply Quality, Legal, and vendors to generate and route Quality Assurance Agreements for approval. Work with Global Quality Compliance to request vendor audits when qualifying vendors. Collaborate with External Supply Quality to qualify and reassess shared vendors across sites. Provide critical support for pre-approval inspection readiness, including FDA inspection preparation activities. Ensure vendor management, change management, and material qualification processes are inspection ready. Participate in inspection or audit backroom activities as required. Review and improve vendor management and qualification processes to support inspection readiness. Support day-to-day business needs related to vendor quality compliance.

Requirements:

Bachelor's degree in Life Sciences, Chemistry, Biology, Engineering, Quality Assurance, Regulatory Affairs, or a related discipline required and two years 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 regulated pharmaceutical or manufacturing environment. Knowledge of vendor qualification, material qualification, supplier change management, quality agreements, and change control processes. Familiarity with inspection readiness activities and regulatory inspection support. Strong cross-functional collaboration, documentation, organization, and communication skills. Ability to manage multiple priorities and support business needs in a fast-paced regulated environment.