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

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).

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.

Auditor I, Clinical Quality Assurance

Key skills