Senior Specialist, QC Support, Cell Therapy
Core
Manage the lifecycle activities of QC laboratory equipment, including validation, qualification, maintenance, and troubleshooting to support cell therapy manufacturing.
Role type
Senior Specialist, QC Equipment Lifecycle Management
Builds
Validated and compliant QC laboratory equipment for cell therapy production
Domain
Biopharmaceuticals / Cell Therapy / Quality Control
Required skills
cGMP compliance, equipment validation, troubleshooting, technical writing, data integrity, project management, change management, CAPA handling, GMP documentation review
Preferred skills
SAP, Valgenesis, Maximo, advanced degree, data integrity principles
Technologies
SAP, Valgenesis, Maximo
Responsibilities
Create equipment User Requirements and validation protocols; Schedule and facilitate qualification, calibration, and maintenance; Maintain equipment records and electronic databases; Perform routine troubleshooting and problem solving; Train and mentor others on equipment processes; Review GMP documentation for GDP adherence
Seniority
Senior, hands-on IC