Pre-Production Specialist

Position Summary

We have an opportunity for a Pre-Production Specialist to join our team. In this role, you will manage Fast Chain Assembly Orders and batch records within the SFX system for the global network. You will create site packaging and shipment orders using SupplyFlex Aggregator and perform study setup, design, and writing of batch records. This position involves working closely with global teams and site-specific departments to ensure accurate and timely preparation of client orders for production.

Shift: Monday to Friday 8am-4:30pm. Location: San Diego or Kansas City 100% Onsite

The Role

• Manage client demand received via various data exchange methods to ensure timely processing and prevent patient risk
• Review and audit assembly and shipment order packets for accuracy; check availability and select bulk material within SupplyFlex Aggregator
• Generate assembly and shipment orders for Clinical Trial Materials in SupplyFlex Aggregator to meet client demand and service levels
• Execute manual business continuation process during SupplyFlex outages
• Assign kit numbers using Excel and Clinicopia when not provided by the client
• Collaborate with PM, PGM, and GBO during study setup to create aggregation schedules and provide feedback on PADIs
• Manage aggregation execution and monitor patterns to identify schedule changes
• Identify and resolve supply chain issues, reporting findings to relevant stakeholders
• Ensure compliance of assembly and shipment orders with SOPs and Packaging and Distribution Information (PADI)
• Attend global project kick-off meetings to gather information for study setup and XBR tasks
• Coordinate study setup requirements with Production, Quality Assurance, Label Control, and Packaging Design/Engineering
• Identify required Item Numbers and submit requests to MDM
• Generate Study Setup parts in collaboration with all involved sites and global MDM
• Ensure regulatory differences are considered in study setup and included in SBI and SBOM
• Create executable batch records based on project documentation, including labeling, kitting, and assembly
• Create JD Edwards Router, BOM, Purchase Order, and Work Order
• Perform setup of GSA and Clinicopia
• Communicate with clients to address questions and provide required documentation
• Manage multi-site prioritization and workload distribution to meet client deliverables
• Support project timelines to ensure milestones are met and deliver packaging documentation on time
• Other duties as assigned

The Candidate

Minimum Requirements

• High School Diploma or General Education Diploma and at least 10 years of Pharmaceutical Packaging experience
• High attention to detail while managing multiple projects and priorities under tight deadlines
• Strong computer skills, including SupplyFlex, SupplyFlex Aggregator, Prisym, Microsoft Excel, JD Edwards, GSA, SharePoint, and ability to learn new systems
• Strong organizational skills
• Proven written, verbal, and interpersonal communication skills
• Ability to work effectively under pressure, prioritize tasks, and meet competing demands
• Ability to interpret instructions in written, oral, diagram, or schedule form
• Ability to work independently
• Effective communication, logical thinking, and investigative skills

Preferred Skills & Background

Bachelor’s Degree and 3 years of Pharmaceutical Packaging experience preferred