Team Lead - 3rd Shift
Core
Lead a 3rd shift team in packaging clinical trial supplies, ensuring compliance with regulatory requirements and GMPs.
Role type
Team Lead, clinical supply packaging
Builds
Clinical trial drug products and components
Domain
Biopharmaceuticals / Clinical Supply Services
Required skills
GMP compliance, batch record review, defect inspection, process improvement, safety analysis, shift leadership, equipment operation, visual management, CAPA identification, inventory management
Preferred skills
Bachelor's degree in science, experience with controlled substances, pallet stack licensing
Technologies
Entropy, TrackWise, Microsoft Excel, Inventory Systems, Quality Systems
Responsibilities
Review packaging batch records for accuracy and SOP compliance; inspect drug products and labels for defects; perform Job Safety Analysis on new equipment; drive process improvements and analyze data; support supervisor in safety/quality investigations; coordinate on-time production start activities; manage shift documentation and daily reporting.
Seniority
Mid-level, hands-on IC with team management duties