Clinical QA Auditor reports to and takes direction from the Manager, Quality Assurance Auditor. Clinical QA Auditor will ensure the development, improvement, and maintenance of clients Clinical Quality Management System in line with current Good Clinical Practices and associated regulations to support phase 1-3 clinical trials, US and Ex-US.
Essential Duties And Responsibilities
Ensure Clinical Quality and Compliance with GCP and associated regulations for US and Ex US studies (Phase 1-3)
Oversight and maintenance of Clinical Quality Management Systems
Develop, manage and maintain the clinical Audit program in compliance with GCP including but not limited to audits of clinical sites, contract CROs, key vendors (e.g. data management)
Trial Master File Audit Program
Development of standards and practices for GCP compliant clinical trial management
Education and/or Experience
Bachelor's Degree in Chemistry, Biology, or Life sciences/related preferred.
Auditor's Certification is a plus.
Competency in MS Office, Adobe Acrobat, and Quality systems databases.
3-5 years' experience with Clinical Quality Systems in the drug/biopharma fields.
3+ years auditing experience is ideal.
Experience in implementation and maintenance of Clinical Quality Systems.
Demonstrated knowledge of Quality Systems and cGxP within an FDA- and EMA-regulated environment.
To be determined as required for improvement within the Quality Department
Other special projects and/or duties may be assigned by Management.
Will require Continental US and potentially some International travel of up 20%.
None at this time
Language, Mathematical, and/or Reasoning Ability
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
Ability to write routine reports and/or correspondence.
Ability to speak effectively before groups of customers or employees of organization and in a high-pressure environment.
Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
While performing the duties of this job, the employee is frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear. The employee is occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl. The employee may frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, and ability to adjust focus. Additionally, in the performance of the duties of this job, the employee may be required to travel drive a motor vehicle, communicate using telephone and e-mail. The physical demands described here are representative of those that must be met by an employee to successfully perform the functions of this job. Reasonable accommodations will be made to enable individuals to perform these functions.