The Scientist – QC Laboratory Informatics supports laboratory operations by ensuring electronic laboratory systems function per intended purpose and use, including end-user functionality and compliance with company and regulatory requirements. Initially, the role will work with global/local IT to populate master data, configure systems, and assist in installing and qualifying QC laboratory IT systems (e.g., LabVantage LIMS, MODA, NuGenesis ELN/SDMS, Empower). The role evolves into monitoring, execution, and maintenance of QC Laboratory IT Systems with continuous improvement and data integrity focus. Serves as business representative/SME for laboratory IT systems, mentors peers, oversees management reviews, laboratory metrics/documentation, and supports internal/external audits.
Key Objectives/Deliverables:
- Validate laboratory equipment and software systems
- Maintain validated state of software-based computerized systems
- Lead/support QC IT system deployments and upgrades
- Ensure and act as local representative for data integrity
- Perform non-terminal record monitoring and support audit trail discrepancies
- Apply quality principles/cGMP to develop local procedures, training, and practices
- Create/revise worksheets; update lab execution system documentation and methods
- Support audit/inspection activities and comply with safety standards
Basic Qualifications:
- Bachelor’s degree in computer science, life science, applied science, or related field
- IT systems experience (installation/qualification, master data, configuration)
- Minimum 3 years GMP laboratory experience
- Authorized to work in the United States full-time; no visa sponsorship
Additional Skills/Preferences:
- Master’s degree; Microsoft Office, LIMS, laboratory execution, chromatography, ELN implementation
- Experience operating/implementing lab IT (LIMS/automated execution)
- Deviation/investigation experience; computer system validation
- Knowledge of compliance/regulatory expectations; strong written/oral communication
- Ability to work in a lab environment with appropriate PPE
Additional Information:
- 8-hour days, Monday–Friday; occasional off-hours/weekend support (24/7 operations)
- Minimal travel required