Gxp Laboratory Systems Administrator

The Position 

The GxP Laboratory Systems Administrator position is responsible for supporting the development and delivery of various laboratory systems including daily system administration of GxP systems. The GxP Laboratory Systems Administrator will be responsible for defining standard business processes, configuring/testing/validating the software solutions, deploying the solutions across multiple Arrowhead Pharmaceuticals sites, and then supporting those software solutions. The position works closely with the business, consulting partners, and internal IS&I teams. The GxP Laboratory Systems Administrator will serve as an expert resource, bringing forth opportunities and other complementary solutions to help support the growth of Arrowhead Pharmaceuticals and influence decisions regarding business process changes.

Responsibilities  

Business

• Support and system administration for identified applications
• Perform investigation and resolution efforts for 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, Arrowhead Pharmaceuticals policies and SDLC
• Draft CSV/CSA documentation for example, validation plans, design specifications, traceability matrices, functional user and user requirements 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
• Perform updates to the global systems inventory for applications
• Coordinate release of new versions of applications into respective environments including Development, Testing and Production environments
• Develop business scenarios to test applications
• Verify installation and operation of applications
• Document analysis and/or testing related to infrastructure changes. (e.g., operating system patches, significant network changes)

Requirements:

• Bachelor’s degree in computer science or life sciences, other related field, or equivalent experience
• 4+ years experience related to the administration, operation, and maintenance of Laboratory Information Management Systems (LIMS) Chromatography Data Systems, Spectrophotometry Systems, and ancillary/supporting laboratory systems in a GxP environment
• Advanced knowledge of computer programs (e.g., MS Word, MS Excel, computerized data acquisition systems)
• Ability to multi-task and participate in multiple projects and department initiatives concurrently
• Ability to produce high quality results while working under the pressure of strict deadlines
• Ability to function effectively independently, as necessary, and work with others to achieve team goals

Preferred: 

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