QA Compliance Specialist – Vendor Management
BeOne Medicines · Pennington, NJ · 2 days ago
On-siteManagement$40.18–$53.57/hrContract
Temporary work opportunities align well with professionals seeking career flexibility and non-traditional ways of working, while being driven to deliver exceptional results in high-profile environments. Magnit Direct Source is a service offered by Magnit Global that connects top talent directly to industry-leading clients with flexible temporary assignments across a variety of impactful projects. BeOne Medicines is creating the world’s next generation cancer treatments. As a global oncology company focused on uniting against cancer, BeOne Medicines brings together passionate professionals dedicated to making a difference for patients worldwide. This opportunity is part of BeOne’s Contingent Workforce Program in partnership with Magnit Global. As a temporary contractor supporting BeOne Medicines, you will be employed by our contingent talent partner, Magnit Global, who manages BeOne’s contingent and temporary workforce. Magnit Global is a leading workforce solutions and technology company specializing in contingent workforce management. Magnit partners with organizations across industries including healthcare, pharmaceuticals, research and development, consumer electronics, and more. Magnit offers a comprehensive benefits package, including medical, dental, vision, and 401(k). Magnit is a leading, global professional services and technology company and a certified "Great Place to Work." We have been a leader in contingent workforce management since 1991 and work with leading Fortune 500 companies and other large organizations across numerous verticals including consumer electronics, research and development, pharmaceuticals, health services, and many more. Magnit offers benefits including medical, dental, vision, and 401(k). General Description 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. Essential Functions Of The Job 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. Education/Experience Required Bachelor’s degree in Life Sciences, Chemistry, Biology, Engineering, Quality Assurance, Regulatory Affairs, or a related discipline required and two years of experience. Preferred/Nice To Have Additional certifications or training in quality assurance or regulatory compliance are a plus. This is the pay range that Magnit reasonably expects to pay for this position: $40.18/hour - $53.57/hour Benefits: Medical, Dental, Vision, 401K