GxP IT Systems Support Analyst

Eastridge; Aliso Viejo (CA); Presencial; USD 54 000 - 70 000; Tempo integral

Resumo da oferta

Eastridge seeks a Business Systems Support Analyst to provide Tier-2 support for ERP, CRM, and SaaS platforms in a GxP-regulated environment at the Aliso Viejo, CA site, on-site. The role emphasizes troubleshooting, data corrections, and controlled deployments within an ITIL/SDLC framework.

Responsibilities include incident management, access control, audits, and coordination with Quality, Validation, and IT Security to ensure compliant changes.

Qualificações

• Bachelor's degree or equivalent experience in Information Systems, Computer Science, Engineering, Life Sciences, or related field.
• 3+ years of experience in business systems or application support.
• Experience in a GxP-regulated environment (life sciences, medical device, pharma).
• Understanding of validation concepts (IQ/OQ/PQ), risk-based validation, incident/change management, and audit readiness.
• Strong troubleshooting and analytical skills with ability to support multiple systems and priorities.
• Excellent written and verbal communication, ability to explain technical issues to non-technical users.

Responsabilidades

• Provide Tier-2 support for enterprise and SaaS systems in a GxP-regulated environment.
• Troubleshoot issues across applications, integrations, data flows, and user access; resolve incidents and requests via ITSM tools (e.g., ServiceNow).
• Perform basic system configuration, data corrections, and access management per procedures.
• Manage system changes in line with SDLC and GxP policies, ensuring data integrity, auditability, and access controls.
• Support audits/inspections with logs, evidence, and documentation; collaborate with Quality, Validation, and IT Security on changes.
• Coordinate with vendors and internal SMEs on escalations and complex issues.
• Create and maintain knowledge base articles, SOPs, and troubleshooting documentation; assist releases and controlled deployments.

Conhecimentos

Tier-2 support

ITSM tools

ServiceNow

Troubleshooting

System configuration

Access management

Data corrections

SDLC

GxP compliance

Vendor coordination

Documentation

Formação académica

Bachelor's degree in Information Systems or related field

Ferramentas

Veeva Vault

21 CFR Part 11

Descrição da oferta de emprego

Eastridge seeks a Business Systems Support Analyst to provide Tier-2 support for ERP, CRM, and SaaS platforms in a GxP-regulated environment at the Aliso Viejo, CA site, on-site. The role emphasizes troubleshooting, data corrections, and controlled deployments within an ITIL/SDLC framework.

Responsibilities include incident management, access control, audits, and coordination with Quality, Validation, and IT Security to ensure compliant changes.