Job Opening: Pre-Production Coordinator

Pre-Production Coordinator

1^st Shift

$24/hr

Overview:

   The Pre-Production Coordinator serves as a liaison between Project Management and Packaging Operations. Responsible for assisting in the coordination of activities related to creating packaging batch records and other GMP documents & materials that comply with the clients’ scope. Ensures that the work that is carried out by Packaging Operations is in compliance with regulatory requirements, good manufacturing practices (cGMP) and standard operating procedures (SOPs).

   The primary responsibilities of this position include creating batch records based on source documentation while identifying customer needs and the ability to prepare batch records following GMP standards. This position will coordinate receiving materials associated with PO generation and zero-dollar Purchase Orders.

Responsibilities:

• Interact with Production, Quality Assurance, Label Control, and Package Engineering personnel to communicate project requirements and gather appropriate paperwork for batch records.
• Create batch records based on project source documentation from Project Management including primary, secondary labeling, kitting and assembly.
• Item Master identification and creator of request forms, JD Edwards Router, BOM, Purchase Order, and Work Order creation, GSA set up.
• Create Change Orders and drive resolution to changes required during production.
• Support project timelines as directed by Management, ensuring that key project milestones are met and projects progress in a satisfactory and timely manner.
• Deliver the packaging documentation within agreed upon timelines, ensuring Right First Time
• Work with Label Designers to obtain item numbers for labels and randomization copies for batch records.
• All other duties as assigned.

Education or Experience:

• A high school diploma or GED is required
• Associate or bachelor’s degree is preferred

Knowledge/Skills Requirements:

• GMP experience is preferred
• At least one year experience working in a pharmaceutical environment is preferred
• Experience working in preparation of packaging batch records, packaging, labeling, assembly, and distribution of clinical trial materials is preferred
• Must possess verbal, written, and interpersonal communication skills appropriate for a business environment
• Must have ability to work with minimal supervision
• Must be computer literate with past experience using spreadsheets and word processing programs

 #nowhiring

 #nowhiring