Assoc. Spclst, Operations (WDA)
Core
Coordinate and support manufacturing activities, batch documentation, and continuous improvement for the Integrated Process Team (IPT) in biopharmaceutical production.
Role type
Operations Support Specialist (Manufacturing)
Builds
Biopharmaceutical products via manufacturing and packaging processes
Domain
Biopharmaceuticals / Manufacturing Operations
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Manufacturing operations, Batch record review, GMP compliance, SAP usage, Inventory management, Continuous improvement methodologies, Documentation preparation, Change management, EHS compliance, Technical skills training
Preferred skills
Knowledge of Safety and GMP regulations, Experience in logistics or technical support
Technologies
SAP, MES, MPS tools (8-steps Problem Solving, SMED, 5S)
Responsibilities
Perform manufacturing batch review within MBTR target; Manage inventory for consumables, PPE, tools, and equipment; Lead change executions for manufacturing documentation; Coordinate technical skills training for shopfloor staff; Support continuous improvement projects to increase throughput and reduce cycle time.
Seniority
Mid-level, hands-on IC