Specialist, Supply Chain

2 weeks ago

Hamilton, United States RESILIENCE US INC Full time

A career at Resilience is more than just a job - it's an opportunity to change the future. Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need. For more information, please visit The Specialist Supply Chain is responsible for creating new components to support the launch of new products, managing changes to existing materials, and delivering the packaging documentation change processes for the West Chester supply site. This includes changes to packaging artwork and the links to the Materials Creation process. The Specialist Supply Chain will independently manage assigned packaging documentation change jobs to meet the needs of key internal customers, including New Product Introduction, site production, Regulatory Affairs, and the project teams. This role also serves as the site's SAP super user. This must be done while maintaining compliance to cGMP's and other regulatory requirements. Provide primary support and coordination for packaging documentation changes. This includes packaging artwork changes and completion of Bill of Material (BOM) change forms. Project manage packaging documentation changes from initial notification to implementation in a way that ensures sufficient time is available to implement the change to timescales requested by the customer. This includes coordination between and understanding the market expectations and communicating throughout the site (ensuring QA and planning are aligned). Create Operations Change Management (OCM) records and appropriate Action Items to support the creation of new components and changes to existing components. Hold and participate in routine Job Tracking communication meetings with key assigned customers as needed. Maintain Job Tracking information for assigned jobs, including maintaining a forward view of upcoming changes. Maintain artwork within the appropriate system (Gazelle) and ensure approved documentation is transferred to approved vendors/suppliers as needed. Manage the use of external artwork resources as appropriate. Send artwork samples as required to the appropriate representative per MIF. Lead or support cross-site initiatives to standardize workflows and align processes with internal and external customers. Set up and progress projects within Gazelle for Artwork Order Requests (AOR), Technical Labeling Request Forms (TLRF), and Labeling Request Forms (LRF) form for packaging documentation changes. Initiated and maintained the SAP Master Data Governance (MDG) system for globally planned materials for the West Chester site. Lead or participate in inter-departmental and inter-company project teams. Interface with appropriate Marketing, Operations, Project Management, Quality Assurance, and Development personnel. Coordinate SAP transactions required to create new components to ensure timely implementation. Minimum Qualifications Experience in one or more of the following areas- Packaging operations, Production Planning, Quality Assurance, Packaging Technical Services, or MRP and Advanced Planning Systems Basic understanding of the packaging processes, artwork processes, compliance issues, and cGMP's Knowledge of cGMP and FDA regulations involving data management and validation requirements Detailed knowledge of SAP, Material Resource Planning (MRP), and Advanced Planning Systems related to pharmaceutical production processes Good interpersonal and project management/coordination skills required Must be analytical, assertive, detail-oriented, highly disciplined, independent, and able to prioritize with minimum supervision Demonstrated high-level attention to detail Preferred Qualifications Bachelor's degree, preferably within a te

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