Clinical Production Specialist
Core
Oversee execution, training, and supervision of clinical production staff for pharmaceutical packaging batch records, ensuring safety, quality, and compliance.
Role type
Senior IC clinical production specialist (packaging operations)
Builds
Clinical trial supply kits, blister cards, bottles, and pouches for global clinical trials
Domain
Clinical trials / Pharmaceutical manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Supervision of production staff, GMP compliance, packaging equipment operation, controlled substance reconciliation, inventory management, data entry, production rate tracking
Preferred skills
Experience with clinical trial manufacturing, JD Edwards ERP systems
Technologies
Automated bottle lines, form-fill-seal equipment, card sealing, vial and ampoule labelers, pouch equipment, medical device tray sealing, JD Edwards
Responsibilities
Monitor and perform packaging functions for assigned Production Batch Records, oversee batch record operations in primary and secondary production rooms, ensure correct placement of look-alike product combinations, handle refrigerated and frozen clinical trial material, manage staging and inventory label generation, track production rates and labor hours
Seniority
Mid-level, hands-on IC
