Quality Control Lab Systems Analyst

Role Summary

Quality Control Lab Systems Analyst at Lilly. Provides in-depth support to the QC laboratories for new and existing laboratory equipment, including selection, implementation, maintenance, and continuous improvement of equipment. Serves as a technical lead on equipment implementation and validation projects and as a representative on project teams. Identifies and resolves QC equipment compliance and data integrity issues.

Responsibilities

• Act as business representative and SME for laboratory systems (e.g., StarLIMS, MODA, NuGenesis, Empower, LabX).
• Serve as primary interface with customers including QC, IDS, VTS, QA, and vendors related to equipment and software.
• Provide support, troubleshooting, and maintenance of QC lab systems (on-call as needed).
• Assist with selection and implementation of equipment within the QC laboratories and upgrades to existing systems.
• Provide training, documentation, and post-implementation support to users of new applications or systems.
• Lead site deployment and upgrade activities of QC laboratory systems.
• Serve as a technical lead on QC computer system validation projects, drive technical implementation and design/configuration, review validation docs, and execute IQ/OQ/PQ protocols as needed.
• Author and manage change control related to QC lab systems.
• Ensure validated computerized lab systems are maintained in a manner compliant with corporate and regulatory requirements (including 21 CFR Part 11).
• Identify compliance issues and process improvements related to ongoing administration of QC computerized systems, implementing effective resolutions.

Qualifications

• Required: Bachelor’s degree or higher in sciences, engineering, or related field (or equivalent work experience).
• Required: Proficiency with computer systems and laboratory software (Trackwise, Waters Empower, MODA, LabX, STARLims, etc).
• Required: Experience in a cGMP regulated environment related to QC laboratories or computer systems.
• Required: Good interpersonal skills and ability to work effectively in a team-based environment.
• Required: Demonstrated learning agility, creativity, and ability to apply learnings.
• Required: Highly motivated with strong communication, organization, and analytical skills; able to communicate with cross-functional teams and management with minimal assistance.

Skills

• Strong problem solving and analytical abilities.
• Effective verbal and written communication.
• Ability to build relationships across diverse teams and locations.
• Knowledge of computer system validation requirements.

Education

• Bachelor's degree in a scientific field (e.g., computer science, chemistry, microbiology, biology) or 5+ years of relevant GMP laboratory experience.

Additional Requirements

• Shift: M-F Days.
• Location: Onsite-Branchburg, NJ.