What are the responsibilities and job description for the IT Compliance Analyst position at EA Team, Inc.?
Job Details
Job Title : IT Compliance Analyst
Location : Emeryville, CA
Duration : 12 months
Job Description:
Working experience on SaaS Validation (e.g systems ELN/LIMS, Clinical trial and data management systems, Clinical submission systems)
Ensures IT operates in compliance to GxP regulations & ensures compliance objectives are demonstrably met with auditable evidence on an ongoing basis.
2. Builds effective partnerships with business process owners, IT system owners, system administrators, Quality staff, internal/external auditors, inspectors & other cross-functional stakeholders to develop, implement & maintain the IT compliance program.
3. Manages IT policy, process & control effectiveness & to ensure compliance objectives are demonstrably met for in scope IT systems, data & processes.
4. Develops, manages & maintains compliance strategy, governance, policies, processes, controls, improvements, risk assessments, compliance checks & team domain knowledge to ensure the following key activities are effectively & efficiently executed for IT systems:
a. System Validation/Assurance, Periodic Review
b. IT Change Management & SDLC
c. Service Continuity & Data Protection/Backup
d. System Access & Inventory Management
e. IT Incident, Non-Conformance, CAPA Management
f. IT Document Control, Training & Curriculum Management
5. Manages IT compliance-related staff, service providers, budgets, audits, inspections & projects.
6. Conducts risk assessments of key systems, accounts, & other in scope areas & activities to inform & ensure compliance.
7. Directly manages and acts as the primary IT contact for all GxP compliance audits and inspections.
8. Provides expert consulting across stakeholders of the IT regulatory landscape & upcoming changes, of compliance requirements & best practices & of continuous improvement.
9. Leads the development of IT compliance training to ensure staff understand & adhere to IT policies, procedures, controls & tools to ensure a compliant & consistent IT control environment.
10. Develops, socializes & reinforces responsibility matrices to ensure compliance responsibilities are clearly understood
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