Specialist II, Supply Chain

Resilience•Blue Ash, OH

4d•$60,000 - $93,750•Onsite

About The Position

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. The Specialist II, 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 II, Supply Chain independently manages assigned packaging documentation change jobs to meet the needs of key internal customers, including New Product Introduction, site production, Regulatory Affairs, and project teams. This role also serves as the site's SAP super user. All work is performed in compliance with cGMPs and other applicable regulatory requirements.

Requirements

Experience in one or more of the following areas: packaging operations, production planning, quality assurance, IQC packaging technical services, or MRP and advanced planning systems.
Working knowledge of packaging processes, artwork processes, compliance issues, and cGMPs.
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 and coordination skills.
Analytical, assertive, highly disciplined, and independent, with demonstrated high-level attention to detail .and the ability to prioritize competing work with minimum supervision.

Nice To Haves

Bachelor's degree, preferably in a technical or scientific field, with knowledge of MRP and planning related to pharmaceutical production processes.
3+ years of experience in packaging documentation, artwork management, supply chain or a related function with a cGMP-regulated environment.
Experience with change management (Veeva or Track wise).
Proven ability to work independently and professionally in a cGMP-regulated environment.
Knowledge of inventory control and document management systems.

Responsibilities

Provide primary support and coordination for packaging documentation changes, including packaging artwork changes and Bill of Material (BOM) change form completion.
Project manage packaging documentation changes from initial notification through implementation, ensuring sufficient time is available to implement the change to the timescales requested by the customer. This includes understanding market expectations and communicating throughout the site so that QA and Planning remain aligned.
Create Operations Change Management (OCM) and Veeva 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, and maintain Job Tracking information for assigned jobs, including a forward view of upcoming changes.
Maintain artwork within the appropriate artwork management systems and ensure approved documentation is transferred to approved vendors and suppliers as needed.
Manage the use of external artwork resources as appropriate.
Send artwork samples as required to the appropriate representative per MIF.
Set up and progress projects within Gazelle for Artwork Order Requests (AOR), Technical Labeling Request Forms (TLRF), and Labeling Request Forms (LRF) for packaging documentation changes.
Initiate and maintain the SAP Master Data Governance (MDG) system for globally planned materials for the West Chester site.
Coordinate SAP and D365 transactions required to create new components to ensure timely implementation.
Serve as the site's SAP super user and support the site with ERP master data queries.
Support the site with ERP (SAP/D365) access requests.
Support cross-site initiatives to standardize workflows and align processes with internal and external customers.
Participate in inter-departmental and inter-company project teams, representing packaging, documentation and master data requirements.
Interface with appropriate Marketing, Operations, Project Management, Quality Assurance, and Development personnel.
Create and update supporting documentation for specific job functions.
Support various site-driven projects and market launches.