GxP Laboratory Systems Administrator

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.

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)

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

Arrowhead provides competitive salaries and an excellent benefit package.

Candidates must have current, valid authorization to work in the country where this role is located.

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