Quality Specialist

Company: Oxford Global Resources

Schedule – Full Time (remote)
LOA – 12 months with an Extension
Fixed Term Contract (Salary)
Number of years experience – 3 years
Start - September
The role will require the candidate to act as IT Support to the Audit team. They will be very hands on who can work both in teams and individually, They will be required at some point during their contracts to work both US and Asia times while Audits are taking place in these areas.
Skills required; Must Have the following;
IT Validation
Data Integrity
Quality Engineering
GXP
Power BI
Audits
Data Analytics & Power BI (build dashboards, maintain and enhance existing queries)
Smartsheet expertise, to maintain and update existing workflow (intake form, routing, configurations)
AI experience, to automate daily activities
Operate independently, demonstrating critical thinking
IT Validation for Audit Support requirements:
1. Facilitate audit request process for GxP regulatory inspections, customer audits, and internal quality audits
* Develop a strong understanding of Client SLC and system evidence to support audits
* Leverage available resources and improve resources to enhance or maintain with changes in environment
* Coordinate audit support activities with appropriate Client system SMEs to fulfill audit requests; escalate risks and issues, to ensure timely resolution/responses in alignment with agreed SLAs.
* Build relationships with system SMEs to facilitate the audit support process
* Engage in ongoing dialogue with compliance team to identify and obtain alignment on process improvements.
* Drive implementation of process improvements:
o streamline data collection of audit requests, propose and implement smartsheet updates to minimize site data input while ensuring appropriate data is captured for beneficial analytics
o Review lessons learned to identify challenges and reduce cycle times
o identify opportunities to increase self-service portal usage
o analyze audit request data to propose improvements in expanding evidence in self-service portal, reusability of evidence, etc.
1. Execute mock audit activities, as requested, to enable inspection readiness.
2. Build data analytics and perform analysis on audit data:
o O&F audit request data
o internal quality audit observations
o external inspection data (including observations and warning letters) using external sources, e.g. Redica
o identify potential gaps/remediation needs; establish cadence and format to share insights
o improvement opportunities (proactively addressing gaps based on regulatory insights); frame opportunities for consideration by appropriate Quality System CoE
o propose continuous improvement (CI) initiatives and execute initiatives to completion
1. Maintain self-service portal links, ensuring current evidence is published
2. Continuous Improvement
* Use technology, automation, and AI to implement enhancements to audit request platform and audit self-service capabilities
* Monitor feedback and propose expansion of capabilities and improvements
1. Status Reporting
* Provide weekly status reporting
* Conveying audit request processing, improvement opportunities, and progress on improvement implementations
Logistics:
* Provide audit support coverage with 2 offshore resources, covering time zones of:
o Resource 1: 8pm CST – 5am CST (Note Resource 1 may require to move to Asian timezone if audits or inspections planned during this period)
o Resource 2: 8am CST – 5pm CST
* During active audits, perform handoff between Resource 1 and 2 (and vice versa) to ensure no requests are dropped

apply