Prologistix is currently seeking new faces to join the premier pharmaceutical manufacturer located just on the south side of Kansas City, Missouri.
Shifts Available: 1st shift
Monday-Friday 7:00am - 4:00pm - $24/hr.
The Pharmaceutical Pre-Production Coordinator serves 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.
Job 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.
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.
Job 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
Education or Experience:
A high school diploma or GED is required
Associate or bachelor’s degree is preferred
#nowhiring
Numbers & Facts
Location
Kansas City, MO
Job Type
Full-time
Skills
Bill of Materials (BOM)unmatched
Biotech and Pharmaceuticalunmatched
Change Requests/Ordersunmatched
Clinical Trialunmatched
Communication Skillsunmatched
Current Good Manufacturing Practice (cGMP)unmatched
Documentationunmatched
Drug Manufacturingunmatched
GMP (Good Manufacturing Practices)unmatched
High School Diplomaunmatched
Interpersonal Skillsunmatched
J D Edwardsunmatched
Needs Assessmentunmatched
Network Routersunmatched
Organizational Skillsunmatched
Process Improvementunmatched
Project/Program Coordinationunmatched
Project/Program Managementunmatched
Purchase Ordersunmatched
Quality Assuranceunmatched
Regulatory Complianceunmatched
Regulatory Requirementsunmatched
Requirements Managementunmatched
Shipping/Receivingunmatched
Standard Operating Procedures (SOP)unmatched
Writing Skillsunmatched
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