Essential Duties and Responsibilities:
Applies Good Manufacturing Principles in all areas of responsibility.
Demonstrates and promotes the company vision.
Evaluates customer clinical research packaging specifications with the sales representative, the customer and/or Project manger II or Senior Project Manager.
Determines the preliminary design of the study and evaluates and understands the study.
Initiates the involvement of appropriate departments and maintains continuous communication with those departments.
Assist Sales personnel with customer teleconferences, visits and audits.
Prepares packaging quotations by ascertaining the following:
- Bill of Materials – FCS vs. Customer Supplied Components
- Description of packaging operations
- Production scheduling
- Tooling requirements
- Packaging Samples
Shares tasks with the Document Specialist including generation of the MBOM, review accuracy of production orders, order clinical labels, order approved components and the various tasks associated with completing a project.
Works with Project Support Associate to perform the necessary tasks associated with each packaging process.
Works with Sales representatives to finalize project quotations organize and complete customer sample packets.
Disperses customer information and specifications to all necessary internal departments.
Develops MS project timeline for each project when appropriate. Communicates critical milestones to the scheduler and customer.
Obtains approval for the purchase of FCS supplied components, clinical labels, etc. when an official Purchase Order and/or signed quotation has not been obtained from the customer.
Assists in performing investigations and resolve conflict both internally and externally.
Verifies final production information for Accounting Dept. prior to invoices being released. Continues monitoring of JOTS financial data.
Responsible for learning and mastering all internal systems associated with projects. (i.e JOTS, GPM, TrackWise)