Principal Quality Control Specialist, Master Data
Core
Creating and sustaining a fully digital QC laboratory by managing complex Master Data sets to support high-volume Drug Product manufacturing operations.
Role type
Principal Quality Control Specialist, Master Data
Builds
Digital QC laboratory infrastructure and data governance for next-generation metabolic medicines
Domain
Pharmaceutical manufacturing (Cardiovascular, Renal, Metabolism)
Deliverable
production ML models | product features | dashboards & analysis | infrastructure | physical/clinical work
Required skills
Master Data management, cGMP regulations, Root Cause Analysis, CAPA management, Change Control, SOP authoring, analytical equipment administration, database management, system training
Preferred skills
Labware (LIMS), Binova (LES), SAP, Mettler Toledo LabX, Waters Empower Chromatography Data System, Veeva, ValGenesis
Technologies
Labware, Binova, SAP, Mettler Toledo LabX, Waters Empower, Veeva, ValGenesis
Responsibilities
Create, update, and test Master Data and system settings; lead or participate in Quality Control Investigations; own Corrective and Preventive Action Plans and Change Controls; author and approve standard operating procedures and risk assessments; perform periodic reporting and system evaluations; conduct end-user training for supported systems.
Seniority
Principal, hands-on IC
