Senior Support Specialist- Lab Operations
Core
Plans and executes validation activities, manages purchasing requisitions, and supports the implementation of QC Laboratories' validation programs to ensure timely delivery of goods and services.
Role type
Senior Support Specialist (Lab Operations & Validation)
Builds
Validated equipment, utilities, facilities, and manufacturing processes; compliant purchasing workflows
Domain
Pharmaceutical manufacturing (API, Bulk Drug, Finished goods) / Quality Systems / Validation
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Validation program implementation, Change control management, Investigation leading, CAPA implementation, SOP drafting and review, Critical maintenance routine approval, Sample preparation for qualification, Purchasing process management, Regulatory compliance knowledge (cGMP), Quality system maintenance
Preferred skills
Technical school certification, Experience with new installation/systems commissioning
Technologies
SRM, ECC, Validation Master Plan, CAPA system
Responsibilities
Audit commissioning and validation documentation; lead and document investigations; implement corrective and preventive actions; draft and review QC Laboratory standard operating procedures; review and approve critical planned maintenance routines; prepare laboratory samples for qualification; manage purchasing activities including shopping carts and requisitions; ensure compliance with company policies and regulations
Seniority
Senior, hands-on IC
