Senior Specialist, Quality Control
Core
Senior Technical Support Specialist responsible for advanced preparation of maintenance jobs, instrumentation maintenance, calibration programs, and Empower CDS coordination in a pharmaceutical laboratory.
Role type
Senior IC Quality Control Technical Support Specialist
Builds
Compliant, reliable supply of pharmaceutical products (Oncology, Vaccines, Animal Health)
Domain
Pharmaceutical manufacturing / Quality Control / Laboratory Operations
Required skills
Empower chromatography software, CMMS systems (SAP/EAM), analytical instrumentation (HPLC, GC, Dissolution, KF), GMP regulations, Root Cause Analysis, Change Control, Vendor Management, Laboratory Information Management System (LIMS), Equipment Qualification, Preventive Maintenance Planning
Preferred skills
Experience in coordinator role, Method Transfer activities, Digital methods creation
Technologies
SAP, EAM, GLIMS, Empower, eShopFloor, LabX
Responsibilities
Coordinate calibration program and maintenance planning operations; Validate and maintain site master data in Empower CDS; Lead problem solving to reduce laboratory downtime; Manage equipment procurement, validation, and qualification; Author and approve SOPs and Change Requests; Participate in internal and external audits and inspections.
Seniority
Senior, hands-on IC
