GxP Laboratory Systems Administrator

Scorpion Therapeutics; Madison (WI); On-site; USD 85,000 - 130,000; Full time

Benefits offered by this job

Competitive salary

Excellent benefits

Job summary

Scorpion Therapeutics in Madison, WI seeks a systems administrator to support and maintain laboratory information management systems (LIMS) and related platforms in a GxP environment.

The role emphasizes coordinating with business and IS teams, managing user access, and contributing to CSV/CSA documentation and audits. Strong multitasking and problem-solving are required to ensure compliant, reliable operation.

Qualifications

• Bachelor’s in CS or life sciences or related field or equivalent experience.
• 4+ years administering LIMS and related lab systems in a GxP environment.
• Advanced knowledge of MS Word and Excel; data acquisition systems.
• Ability to multi-task across projects and initiatives.
• Ability to deliver high-quality results under strict deadlines.
• Ability to work independently and with others.

Responsibilities

• Support and system administration for identified applications
• Investigate and resolve technical and business process issues
• Communicate issues/resolutions with users and department managers
• Escalate issues to application vendors as necessary
• Troubleshoot and collaborate with end users and departmental managers
• Maintain functional subject matter knowledge for assigned applications
• Perform other duties as assigned
• Coordinate communication between business and IS/Informatics
• Triage escalation of technical issues
• Update global systems inventory for applications
• Coordinate releases into Development, Testing, and Production environments
• Develop business scenarios to test applications
• Verify installation and operation
• Document analysis/testing for infrastructure changes (e.g., OS patches, major network changes)

Skills

Multi-tasking

Communication

Independent work

Analytical thinking

Education

Bachelor’s in CS or life sciences or related field

Tools

MS Word

MS Excel

Data acquisition systems

Job description

Responsibilities

Business:

• Support and system administration for identified applications


• Investigate and resolve technical and business process issues


• Communicate issues/resolutions with users and department managers


• Escalate issues to application vendors as necessary


• Troubleshoot and collaborate with end users and departmental managers


• Maintain functional subject matter knowledge for assigned applications


• Perform other duties as assigned

Regulatory:

• Perform periodic application review and manage user access


• Represent application documentation in client and regulatory audits


• Contribute to audit finding responses


• Contribute to CSV/CSA/computer system validation and software assurance projects, including application change control as required by GxP, policies, and SDLC


• Draft CSV/CSA documentation (validation plans, design specs, traceability matrices, user requirements, test scripts, deviations, summary reports)

Information Systems/Informatics:

• Coordinate communication between business and IS/Informatics


• Triage escalation of technical issues


• Update global systems inventory for applications


• Coordinate releases into Development, Testing, and Production environments


• Develop business scenarios to test applications


• Verify installation and operation


• Document analysis/testing for infrastructure changes (e.g., OS patches, major network changes)

Requirements

• Bachelor’s in CS or life sciences (or related field) or equivalent experience


• 4+ years administering/operating/maintaining LIMS, chromatography data systems, spectrophotometry systems, and related lab systems in a GxP environment


• Advanced knowledge of computer programs (e.g., MS Word/Excel, data acquisition systems)


• Ability to multi-task across projects and initiatives


• Ability to deliver high-quality results under strict deadlines


• Ability to work independently and with others

Preferred

• Experience validating/supporting Agilent systems (Openlab, Chemstation, Cary UV)


• Knowledge of GxP/CSV-CSA/21 CFR Part 11/EU Annex 11/SDLC


• Experience with regulated asset management and environment monitor applications


• Computer System Validation and GxP (21 CFR Part 11, Annex 11)


• Pharmaceutical or CRO experience


• Project Management certification

Benefits (if part of description)

• Competitive salaries and an excellent benefit package