Auditor I, Clinical Quality Assurance
Remotedxb
Responsibilities
- Support GCP/GCLP/GVP audits for investigational sites, internal systems, trial master files, and clinical service providers
- Plan, coordinate, and report audits including the escalation of critical observations
- Assist with commercial inspections and inspection readiness activities
- Support GCP compliance activities including investigations, change controls, and procedure development
- Implement procedures and work instructions based on best practices
- Represent the Clinical Quality Assurance Team in cross‑functional projects
Requirements
- BA/BS in life sciences or equivalent field
- 1+ years of GCP or GMP experience
- Knowledge of US CFR, ICH Guidelines, EU, TGA, Health Canada, or MHRA regulations
- Working knowledge of MasterControl, Veeva, or similar eQMS programs
- Proficiency in MS Office (Word, Excel, PowerPoint, MS Project)
- Ability to manage multiple projects simultaneously
About the Company
Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer by harnessing the ability of the human immune system to recognize and attack diverse cancer cells.
#J-18808-LjbffrVacancy posted 4 days ago
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