Scientist, Quality Control (QC) Systems

Scorpion Therapeutics; Harvard (MA); On-site; USD 110,000 - 150,000; Full time

Job summary

Scorpion Therapeutics is seeking a Scientist, QC Systems for the Cell Therapy Facility to develop, configure, and manage QC electronic systems and applications supporting QC operations.

The role includes system data management, validation document creation, troubleshooting, and driving continuous improvement with cross-functional teams in a regulated environment.

Qualifications

• Understanding of Global Regulatory and cGMP requirements.
• Experience with validation and maintenance of laboratory electronic software systems.
• 6+ years' experience with LIMS/ELN/laboratory software systems (e.g., Smart-QC) in regulated environments.
• Ability to work in a fast-paced team environment and meet deadlines.
• Strong written and verbal communication and technical writing skills.
• Mentoring/coaching and influencing/negotiating abilities.

Responsibilities

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

Skills

Regulatory understanding

Team collaboration

Problem solving

Technical writing

Mentoring/coaching

Effective communication

Negotiation skills

Prioritization

Cross-functional collaboration

Education

Bachelor's degree in science or engineering

Tools

Smart-QC

LIMS

ELN

ERP

MES

Job description

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.

Duties/Responsibilities

• 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.

Qualifications

• 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.