Systems Administrator, Electronic GxP Systems

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Kaleo Software

WebsiteLinkedInAll Job Openings

11 - 50 employees

💰 $7M Series A on 2015-10

The information employees need to do their jobs is hard to find. It's spread across systems, documents, and inside the minds of colleagues. We understand how hard it is to get what you need, and we’re here to help. Kaleo automatically turns documents and experts into searchable FAQs so finding anything is as easy as asking for it. Instead of creating ‘yet another place’ to find answers, Kaleo integrates into popular business applications like SharePoint, ServiceNow, and Slack to deliver information when and where employees need it.

📋 Description

• Serve as the system administrator and execution owner for all electronic GxP systems and GxP supporting applications used to create, manage, store, or report regulated quality data • Maintain a complete and current inventory or electronic GxP and GxP-supporting systems, including system purpose, GxP impact, validation status, and system ownership • Ensure all applicable systems are appropriately classified for GxP impact, validated and maintained in a validated state, traceable to intended use and regulatory requirements, and defensible during audits and inspections • Serve as the primary or backup system administrator for multiple electronic systems platforms, for example: platforms and systems supporting document control, training, change control, deviations, investigations, CAPA, audit, customer complaint workflows, electronic batch records, external submissions, and device history file(s) • Configure, maintain, and execute system workflows and forms, metadata and taxonomy structures, user roles, permissions, and security models • Controlled system changes in accordance with validation requirements • Provide quality system execution oversight for GxP-supporting applications that interface with or support GxP activities (e.g. reporting tools, repositories, workflow platforms, and validated interfaces) • Partner with Information Technology and systems owners to ensure appropriate approach and documentation, controlled access and data protection(s), and change management aligned with GxP risk profile • Execute and support system validation activities across the system lifecycle, including validation planning and impact assessments, IQ/OQ/PQ documentation and test execution, and validated evidence maintenance and archival • Ensure all system changes, upgrades, and enhancements follow approved change control and validation procedures • Maintain inspection-ready validation documentation at all times • Develop, maintain, and execute system-level reports while ensuring system data is accurate, reliable, attributable, legible, contemporaneous, original, and complete (ALCOA+) • Serve as a system subject matter expert (SME), including back-room inspection support and direct system demonstrations as required • Provide day-to-day technical support for electronic GxP systems, including issue triage, troubleshooting, and resolution while evaluating new system features and tools to provide recommendations based on compliance and operational impact • Participate in industry forums, user groups, and training related to electronic GxP systems and validation best practices

🎯 Requirements

• Bachelor’s or Master's degree in a scientific, technical, or information systems-related discipline (e.g., life sciences, engineering, computer science, or equivalent experience) • Minimum 6+ years of experience supporting Quality Assurance systems in a regulated pharmaceutical, biotechnology, medical device, or combination product environment • Demonstrated hands-on experience administering electronic GxP systems, such as MasterControl, Veeva, TrackWise, Documentum, or equivalent quality systems • Proven experience supporting validated system lifecycles, including system implementation, configuration, change control, upgrades, and decommissioning • Working knowledge of GxP systems validation principles, including risk-based validation, testing execution, and maintenance of validated state • Strong proficiency with Microsoft 365 and system reporting tools • Experience supporting internal audits and regulatory inspections as a system SME • Ability to travel occasionally (up to ~10%) as required for system support or inspections.

🏖️ Benefits

• This is a remote opportunity with occasional travel, estimated at less than 10%.