Quality Control Systems Specialist
Core
Support and maintain Laboratory Information Management System (LIMS) and MODA Environmental Monitoring system in a regulated manufacturing environment.
Role type
Quality Control Systems Specialist
Builds
Reliable operation of LIMS and MODA for laboratory testing and environmental monitoring
Domain
Pharmaceutical/Biotechnology/Medical Device manufacturing, Quality Assurance, Laboratory Operations
Deliverable
infrastructure
Required skills
LIMS support, MODA support, troubleshooting, data integrity monitoring, system validation, change control, user training
Preferred skills
GMP knowledge, 21 CFR Part 11 knowledge, Annex 11 knowledge
Technologies
LIMS, MODA
Responsibilities
Maintain LIMS and MODA systems, troubleshoot issues, support system updates and validation, review audit trails, implement system enhancements, train users
Seniority
Mid-level, hands-on IC