GxP Laboratory Systems Administrator

Role Summary

The GxP Laboratory Systems Administrator position is responsible for supporting the development and delivery of various laboratory systems across multiple departments, including manufacturing, CMC, QC, BioAnalytical and DMPK and Clinical Pharmacology. The role involves defining standard business processes, configuring, testing, and validating software solutions, deploying them across Arrowhead sites, and providing ongoing support. The position collaborates with business units, consulting partners, and IS&I teams, and serves as an expert resource to support growth and inform business process changes.

Responsibilities

• Support and system administration for identified applications
• Investigate and resolve technical and business process issues
• Communicate technical issues and resolutions with users and department managers
• Escalate issues to application vendors as necessary
• Troubleshoot and collaborate with end users and departmental managers
• Maintain a high level of functional subject matter knowledge for the assigned applications
• Perform other duties as assigned

Regulatory

• Perform periodic application review and management of user access
• Represent the application documentation in client and regulatory audits
• Contribute to audit finding responses
• Contribute to computer system validation and computer software assurance projects, including application change control as required by GxP and company policies
• Draft CSV/CSA documentation (validation plans, design specifications, traceability matrices, user specifications, test scripts, deviations, and summary reports)

Information Systems and Informatics

• Establish open communication between the business and Information Systems and Informatics
• Triage escalation of technical issues to Information Systems and Informatics
• Update the global systems inventory for applications
• Coordinate release of new versions of applications into Development, Testing, and Production environments
• Develop business scenarios to test applications
• Verify installation and operation of applications
• Document analysis and testing related to infrastructure changes

Qualifications

• Bachelor‚Äôs degree in computer science, life sciences, or related field, or equivalent experience
• 4+ years of experience administering, operating, and maintaining Laboratory Information Management Systems (LIMS), Chromatography Data Systems, Spectrophotometry Systems, and related laboratory systems in a GxP environment
• Advanced knowledge of computer programs (e.g., MS Word, MS Excel, data acquisition systems)
• Ability to multi-task and participate in multiple projects concurrently
• Ability to deliver high-quality results under strict deadlines
• Ability to work independently and with others to achieve team goals

Preferred

• Extensive experience validating and supporting Agilent laboratory systems (OpenLab, ChemStation, Cary UV systems)
• Strong experience with pharmaceutical/CRO industry regulations and guidelines (GxP, CSV/CSA validation, 21 CFR Part 11, EU Annex 11, SDLC)
• Experience with regulated environment asset management and environment monitoring applications
• Knowledge of Computer System Validation, 21 CFR Part 11, Annex 11, and GxP
• Pharmaceutical or CRO experience
• Project Management certification