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Auditor I, Clinical Quality Assurance
Iovance Biotherapeutics, Inc.Auditor I ensuring GCP, GCLP, and GVP compliance in clinical quality assurance at Iovance Biotherapeutics. Supporting audit activities and GCP training in remote environments.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in GCP compliance, audit support, and regulatory requirements while effectively managing multiple projects and collaborating cross-functionally. Proficient in implementing quality assurance procedures and maintaining continuous process improvement initiatives.
Highest-signal resume keywords
GCP ComplianceAudit SupportProject ManagementRegulatory KnowledgeInterpersonal Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
GCP ExperienceGMP ExperienceQuality AssuranceProcedure DevelopmentProcess Improvement
Soft Skills
CollaborationInterpersonal SkillsCommunication
Tools & Technologies
MasterControlVeevaEQMS ProgramsMS Office
Industry Keywords
United States Code of Federal RegulationsICH GuidelinesEU RegulationsTGAHealth CanadaMHRA
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Support GCP/GCLP/GVP audits for investigational sites, GCP internal systems and processes, trial master file and clinical service provider audits. Responsibilities include the planning, coordination, and timely reporting of such audits as well as appropriate escalations of critical observations
- Support and assist with commercial inspections, inspection readiness activities and other related activities as needed
- Support GCP compliance activities including investigations, clinical change controls, procedure development and review, ATC QA audits, and GCP training program development
- Implement procedures and work instructions based on best practices or compliance requirements
- Maintain a continuous process improvement initiative mindset in all areas of work
- Represent the Clinical Quality Assurance Team in cross-functional projects where applicable
Requirements
What you’ll need- BA/BS or equivalent in life sciences or equivalent focus of study from an accredited university or college with 1+ years GCP or 1+ years GMP experience
- Knowledge of pertinent United States Code of Federal Regulations, ICH Guidelines, EU, TGA, Health Canada, MHRA and/or other global/local government regulatory requirements
- Proven ability to manage multiple projects while maintaining quality
- Strong interpersonal skills and ability to work collaboratively with colleagues cross functionally
- Working knowledge of MasterControl or other programs such as Veeva, or other related eQMS programs
- Strong computer skills including MS Office (Word, Excel, PowerPoint, MS Project).
Benefits
Comp & perks- This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers.
- Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects.
- Must be able to remain in a stationary position standing or sitting for prolonged periods of time.
- The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions.