GxP Laboratory Systems Administrator

Arrowhead Pharmaceuticals•Madison, WI

About 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 across multiple departments including, Manufacturing, CMC, QC, BioAnalytical and DMPK, Clinical Pharmacology ad BioMarkers. 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.

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

Nice To Haves

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

Responsibilities

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
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
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)