Auditor I, Clinical Quality Assurance

This is a fully remote position, open to applicants in United States.

📋 Description

• Assist with GCP/GCLP/GVP audits for investigational sites, GCP internal systems and processes, trial master file, and clinical service provider audits. This includes planning, coordinating, and ensuring timely reporting of these audits, along with appropriately escalating critical observations.

• Aid in commercial inspections, activities related to inspection readiness, and other associated tasks as required.

• Contribute to GCP compliance efforts encompassing investigations, clinical change controls, development and review of procedures, ATC QA audits, and the establishment of GCP training programs.

• Execute procedures and work instructions grounded in best practices or compliance mandates.

• Uphold a mindset focused on continuous process improvement across all work areas.

• Act as a representative of the Clinical Quality Assurance Team in cross-functional projects when relevant.

⛳️ Requirements

• Bachelor’s degree in life sciences or a related field from an accredited institution, with a minimum of 1 year of experience in GCP or GMP.

• Familiarity with relevant United States Code of Federal Regulations, ICH Guidelines, EU, TGA, Health Canada, MHRA, and/or other global/local government regulatory standards.

• Demonstrated capability to manage several projects simultaneously while ensuring quality standards are upheld.

• Excellent interpersonal skills with the ability to collaborate effectively with colleagues across various functions.

• Proficient in MasterControl or similar platforms like Veeva, or other related eQMS systems.

• Strong computer proficiency, particularly in MS Office (Word, Excel, PowerPoint, MS Project).

🏝️ Benefits

• This position necessitates repetitive motion and significant movements of the wrists, hands, and/or fingers.

• The role requires the ability to move around within an office environment and occasionally exert up to 10 pounds of force, or a minimal amount of force frequently or constantly to lift, carry, push, pull, or otherwise transport objects.

• The individual must be able to remain in a stationary position, either standing or sitting, for extended periods.

• The physical demands outlined here represent those an employee must fulfill to successfully perform the essential functions of this job. Reasonable accommodations may be provided upon request to facilitate the performance of essential functions.