Job ID :
US - Pennsylvania - Allentown
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 a Senior Project Manager or Team Leader.
- 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.
- Assists in preparing packaging quotations by ascertaining the following:
- Bill of Materials – FCS vs. Customer Supplied Components
- Bill of Assembly – Description of packaging operations
- Production scheduling
- Tooling requirements
- Packaging Samples
- Works with Sales representatives to finalize project quotations organize and complete customer sample packets.
- Shares and organizes tasks with the Project Support Associates, including generation of Master Planning Orders, batch records, ordering of clinical labels (both internal and external), ordering of approved components and the various tasks associated with completing a project.
- Disperses customer information and specifications to all necessary internal departments.
- 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.
- Communicates critical time lines to the scheduler and 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.
- Responsible for learning and mastering all internal systems associated with projects. (i.e. MS Project, JOTS, GPMS)