LIMS Scientist I
Core
Implement and operate the Veeva LIMS system to support laboratory workflows and data integrity at a radiopharmaceutical manufacturing plant.
Role type
LIMS Specialist (Quality Control)
Builds
LIMS system configuration, validation, and operational support for laboratory data management
Domain
Pharmaceutical manufacturing / Radiopharmaceuticals / Quality Control
Required skills
LIMS system administration, Veeva LIMS, GxP compliance, 21 CFR Part 11, system validation, user training, data integrity, change control, root cause analysis, laboratory instrumentation knowledge
Preferred skills
Injectable or radiopharmaceutical experience, HPLC/TLC/GC/Gamma Spec/ICP experience, Labware LIMS, 6 M's/5 Why's/fishbone techniques
Technologies
Veeva LIMS, Labware, HPLC, TLC, GC, Gamma Spec, ICP
Responsibilities
Develop and maintain LIMS procedures and documentation, configure and troubleshoot the LIMS system, serve as primary point of contact for LIMS issues, implement system updates and change controls, provide user training and support, participate in audits and inspections, ensure data security and access management, support business continuity planning
Seniority
Mid-level, hands-on IC