Pre-Production Associate
Core
Plan and prioritize pre-production aspects of clinical trial supply packaging, creating accurate pack designs and documentation to meet client and GMP requirements.
Role type
Pre-production associate (pharmaceutical packaging)
Builds
Clinical trial supplies packaging and labeling
Domain
Pharmaceutical manufacturing / Contract Development and Manufacturing Organization (CDMO)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
packaging design, production planning, supply chain management, GMP compliance, label printing system setup, Global Scan Assembly system setup, documentation creation (Label Print Forms, Batch Records), procurement coordination, data entry in SupplyFlex/JDE/SharePoint
Preferred skills
experience in pharmaceutical packaging, packaging design, production planning, supply chain, logistics, GMP-regulated manufacturing environment
Technologies
SupplyFlex, Microsoft Excel, JDE, SharePoint, Global Scan Assembly system, label printing systems
Responsibilities
Create accurate pack designs reflecting client needs and meeting GMP requirements; raise Quality Issue Forms (QIFs) when pack designs differ from contracts; procure packaging components, label stock, and equipment from approved vendors; coordinate with Project Management for client documentation approval; organize label printing system setups; configure packaging jobs in Global Scan Assembly; create packaging and labeling documentation including Label Print Forms and Batch Records
Seniority
Individual Contributor, operational support level
