QC Instrument Specialist
Core
Support the start-up and lifecycle management of analytical instrumentation in a biotech QC laboratory to ensure validated, calibrated equipment for biologics testing.
Role type
QC Instrument Specialist
Builds
Validated analytical testing capabilities for biologics and ADCs
Domain
Biotechnology / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Analytical Instrumentation, GMP Compliance, Data Integrity, Troubleshooting, Laboratory Documentation, Mass Spectrometry, Calibration, IQ/OQ/PQ protocols, Regulatory Requirements
Preferred skills
Antibody Drug Conjugates (ADC), Continuous Improvement, Technical Writing, Laboratory Safety, Quality Systems Documentation
Technologies
HPLC/UPLC, Mass Spectrometers, Empower, Softmax Pro, GLIMS, LabX, MODA, Biovia, SAP, Veeva
Responsibilities
Procure and install laboratory instrumentation, Execute maintenance and calibration activities, Prepare qualification documentation (SOPs, maintenance plans), Coordinate with QA/IT/Engineering for commissioning, Support troubleshooting and deviations, Maintain inspection readiness
Seniority
Mid-level, hands-on IC
