Specialist, Operations (Night Shift)
Core
Support shop floor execution, batch closeout, troubleshooting, and process improvement in a GMP manufacturing environment.
Role type
Operations Specialist (Manufacturing)
Builds
Steady-state production and continual process improvement initiatives
Domain
Pharmaceutical Manufacturing / cGMP
Required skills
GMP compliance, Batch Record Review, CAPA Management, Equipment troubleshooting, Process optimization, Data analysis, Technical writing, Safety investigations, Production planning
Preferred skills
MPS methodologies, SAP systems, cGMP manufacturing systems, Project management, Lean Manufacturing Tools
Technologies
SAP
Responsibilities
Partner with Operations management to execute production strategies; Author and review SOPs and batch records; Lead safety investigations and problem-solving initiatives; Support on-shift Operations Coaches; Implement MPS principles on the shop floor; Analyze metrics to ensure project success.
Seniority
Mid-level, hands-on IC