Senior Specialist, QCAS Instrumentation
Core
Manage the purchase, installation, qualification, calibration, maintenance, and lifecycle of laboratory instruments in a GMP biopharmaceutical environment.
Role type
Senior Specialist, QCAS Instrumentation
Builds
Supports QC laboratory teams with instrument reliability and compliance for drug product and drug substance manufacturing.
Domain
Biopharmaceuticals / Quality Control / Laboratory Instrumentation
Required skills
GMP environment experience, instrument qualification procedures, calibration and maintenance, lifecycle management, data integrity (21 CFR 11/EU Annex 11), project planning, troubleshooting complex instrumentation, HPLC/UPLC, CE, cIEF, SDS-PAGE, Biacore, HIAC, KF, Liquid Handlers
Preferred skills
Protein biochemistry, technology transfers
Technologies
HPLC, UPLC, CE, cIEF, SDS-PAGE, Biacore, HIAC, KF, Liquid Handlers
Responsibilities
Provide calibration and maintenance services to QC laboratories; review and approve analytical instrumentation qualification and documentation; manage instrument-specific investigations and performance trending; participate in new instrument purchase and qualification; liaise with vendors and sister sites; ensure compliance with regulatory requirements; define instrument-related procedures.
Seniority
Senior, hands-on IC