Quality Systems Specialist II (15 month contract)
Core
Support compliance activities for quality laboratory systems, computer system validation, and equipment lifecycle management to enable product testing, release, and regulatory adherence.
Role type
Quality Systems Specialist (Technical Services)
Builds
Quality laboratory computer systems, equipment, and applications
Domain
Life Sciences / Consumer Health / Laboratory Operations
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Computer system validation, laboratory equipment lifecycle management, master data setup, troubleshooting, regulatory compliance, analytical laboratory methods
Preferred skills
Empower, Biovia LES, Labware LIMS, instrumentation troubleshooting (HPLC, UPLC, UV-VIS, FTIR), technical writing, project management
Technologies
Empower, Biovia LES, Labware LIMS, HPLC, UPLC, UV-VIS, FTIR
Responsibilities
Support regulatory and audit activities for quality laboratory systems; manage user access and audit trail reviews; develop and maintain qualification and validation documentation; perform master data setup and maintenance; provide technical troubleshooting for laboratory systems and equipment; manage laboratory equipment lifecycle including qualification and retirement; facilitate external contractor and vendor visits.
Seniority
Mid-level, hands-on IC