Senior Specialist, QC Support, Cell Therapy
Core
Manage the lifecycle activities of QC laboratory equipment, including validation, qualification, maintenance, and troubleshooting to support GMP-compliant operations.
Role type
Senior Specialist, QC Equipment Lifecycle Management
Builds
Supports QC laboratories in a pharmaceutical manufacturing environment
Domain
Life Sciences / Pharmaceutical Manufacturing / Quality Control
Required skills
Equipment lifecycle management, Validation protocols, GMP compliance, Troubleshooting, Technical writing, Data integrity principles, CAPA management, Change management, Vendor coordination, Database management
Preferred skills
Advanced degree in science, SAP/Maximo/Valgenesis proficiency, Data integrity expertise, Mentoring capabilities
Technologies
SAP, Valgenesis, Maximo
Responsibilities
Create equipment User Requirements and validation protocols, Schedule and facilitate qualification and calibration, Maintain equipment records and electronic databases, Perform routine troubleshooting and problem solving, Train and mentor staff on equipment processes, Review GMP documentation for GDP adherence
Seniority
Senior, hands-on IC