Clinical Auditing Specialist II - Vendor and Information System Audits Team
ThermoFisher Scientific
Job Description
**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
Join us as Quality Assurance Auditor II (Technology Solution Audits Team) and enhance our clinical auditing processes by ensuring regulatory compliance and quality standards.
**What You’ll Do:**
+ Conduct and/or lead external supplier GxP information systems audits as requested by senior management, including but not limited to on-site, virtual, questionnaire, or desktop audits of technology solutions used in clinical trials
+ Assess processes related to computerized systems used in clinical trials, including Quality Management Systems (QMS), System Development Life Cycle (SDLC), information security, data integrity, business continuity, disaster recovery, backup and restore, and data center and/or cloud hosting environments.
+ Provide GxP regulatory consultation and support to internal project teams and stakeholders on inform...
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
Join us as Quality Assurance Auditor II (Technology Solution Audits Team) and enhance our clinical auditing processes by ensuring regulatory compliance and quality standards.
**What You’ll Do:**
+ Conduct and/or lead external supplier GxP information systems audits as requested by senior management, including but not limited to on-site, virtual, questionnaire, or desktop audits of technology solutions used in clinical trials
+ Assess processes related to computerized systems used in clinical trials, including Quality Management Systems (QMS), System Development Life Cycle (SDLC), information security, data integrity, business continuity, disaster recovery, backup and restore, and data center and/or cloud hosting environments.
+ Provide GxP regulatory consultation and support to internal project teams and stakeholders on inform...