Quality Specialist – IT Support for Audit Team (Remote)

About the role

The Quality Specialist will act as the primary IT support for the Audit team, providing hands‑on assistance for GxP regulatory inspections, customer audits, and internal quality audits. This remote, full‑time position runs for an initial 12‑month fixed term with the possibility of extension.

Key responsibilities

• Facilitate audit request processes across US and Asia time zones.
• Develop deep knowledge of client systems and evidence required for audits.
• Coordinate with system SMEs, escalating risks to meet SLA commitments.
• Drive process improvements using Smartsheet, AI automation, and Power BI dashboards.
• Maintain and enhance the self‑service portal, ensuring evidence is current and reusable.
• Execute mock audits and prepare the organization for inspection readiness.
• Analyze audit data (internal observations, external inspection findings) to identify gaps and propose continuous‑improvement initiatives.
• Provide weekly status reports and communicate progress to stakeholders.

Required profile

• Minimum 3 years of relevant experience in IT support, quality engineering or audit assistance.
• Ability to work independently, demonstrate critical thinking, and collaborate within teams.
• Flexibility to work across multiple time zones (US and Asia) as audit cycles demand.

Required skills

• IT Validation
• Data Integrity
• Quality Engineering
• GxP compliance knowledge
• Power BI (dashboard creation and query maintenance)
• Data Analytics
• Smartsheet expertise
• AI experience for automation of daily activities