Senior / Auditor, Quality Assurance (Contractor) - San Antonio - Office-based
Worldwide Clinical Trials
klinische Pharmakologie
San Antonio, TX - USA
Senior Fachkraft / Projektleiter
Experteer Overview
In this QA-focused role, you support the Quality Assurance function to uphold high quality across audits and regulatory activities. You collaborate with QA leadership to plan audits, manage vendor audits, and facilitate sponsor inspections, driving improvements in reports and processes. You will mentor junior auditors, deliver GCP/GLP training, and help ensure compliance with SOPs and regulatory requirements. This role suits a detail-oriented professional who thrives in a fast-paced environment and aims to elevate audit quality and organizational compliance.
Verantwortungsbereiche
- Plan, conduct, and finalize audit reports with QA management
- Monitor audit status across areas and provide progress updates
- Assist with Vendor Audit program management
- Facilitate sponsor audits and regulatory inspections
- Review audit reports to identify clarity and quality improvements
- Identify process improvement opportunities and communicate them to management
- Contribute to CAPAs to ensure corrective actions are implemented
- Provide regulatory guidance and SOP advice
- Assist in training and mentoring less experienced auditors
- Create and deliver GCP/GLP and related training sessions
- Support policy/procedure reviews by QA Management
- Maintain audit records and documentation
Zentrale Anforderungen
- Bachelor's degree in Life Science preferred
- Minimum 5 years in regulatory affairs, auditing, clinical research, monitoring, laboratory, or related field
- At least 3 years in quality assurance auditing
- Willingness to travel
- Ability to coordinate multiple projects and adapt to changing priorities
- Strong professional interaction skills and ability to work independently or in teams
- Excellent oral and written communication skills
Stellenbeschreibung
In this QA-focused role, you support the Quality Assurance function to uphold high quality across audits and regulatory activities. You coll…
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