Scientist, Quality Control; QC) Systems

Position Summary

The Scientist, QC Systems at the Cell Therapy Facility (CTF) is responsible for the development, configuration, and management of QC electronic systems and applications supporting QC operations.

• Create, deploy, review and sustain electronic systems Master Data; perform data verification and system integration (Smart-QC, LIMS, ERP, MES).
• Create/execute computer system validation documents (e.g., UAT, URS, OQ, PQ) and guide QC end users on system enhancements with user requirements and business drivers.
• Provide electronic systems operational support and troubleshooting.
• Own project, CAPA, and deviation/investigation tasks and/or continuous improvement efforts.
• Propose and implement electronic systems improvements to optimize business processes and efficiency; collaborate with end users on business cases.
• Anticipate mid- to long-term business needs and support strategic initiatives.
• Independently troubleshoot and solve problems.
• Train and mentor others on electronic systems use and operation.
• Translate business requirements into technical design requirements; communicate with partner organizations (e.g., IT).
• Facilitate design, testing, and deployment of solutions.
• Perform other tasks as assigned.

• Ability to understand and apply Global Regulatory and cGMP requirements.
• Ability to work in a fast-paced team environment, meet deadlines, and prioritize work.
• Advanced technical problem-solving skills.
• Effective communication with peers and cross-functional teams; demonstrated technical writing.
• Mentoring/coaching and influencing/negotiating skills.
• Knowledge of analytical/microbiological test methods and environmental monitoring programs.
• Bachelor's degree (or equivalent), preferably in science/engineering.
• 6+ years' relevant experience in LIMS/ELN/laboratory software systems (e.g., Smart-QC), preferably in a regulated environment.
• Demonstrated experience with validation and/or maintenance of laboratory electronic software systems.