Quality Assurance Auditor

Role Description

Anticipated Job Role Level (commensurate with education, experience and skill levels): Associate Quality Assurance Auditor

JOB DESCRIPTION

As a staff member within the Global Quality & Compliance group, the Associate Quality Assurance Auditor provides quality assurance oversight to the Veterinary Medicine Research & Development (VMRD) clinical and non-clinical programs.

Be proficient in the understanding of current regulatory requirements in regard to the quality of research for registration of animal products in major global markets. Proficient in performing quality assurance audits and inspections of non-clinical and clinical veterinary product studies and reports, including: protocols, data/data listings, summary & analysis, master study files, final study reports, investigator study sites and in-phase inspections. Be proficient in performing quality assurance audits and inspections of equipment, facilities, CROs and processes that support non-clinical and clinical veterinary product studies. Participate in a variety of Quality Assurance-related activities including staff and project meetings, non-study document reviews, and consultations with VMRD colleagues. May assume the lead role for various projects within GQC. Provide compliance training to VMRD staff and contractors. When requested, participate in government inspections of clinical and non-clinical studies as well as pharmacovigilance and other inspection types (e.g., import/export permits).

EDUCATIONAL BACKGROUND/EXPERIENCE

MINIMUM:

Bachelor's Degree or equivalent in biology, animal science or other relevant science field.

DESIRABLE:

Master's degree or equivalent in biology, animal science or other relevant science field.

WORKS EXPERIENCE/SKILLS

MINIMUM:

• Demonstrated relevant quality assurance auditing experience (minimum 1 year) in veterinary medicine or related regulatory environment (e.g., GCP, GLP, GMP).
• Competency using Microsoft Office suite (e.g., Word, Excel, Outlook).
• Establishment of excellent interpersonal relations; good communications; ability to negotiate, risk assess, and problem-solve.
• Ability to work independently, while fostering good working relationships across physical distance and have flexibility and the capacity to handle multiple tasks at once.
• Ability to travel, if needed (5-15%).

DESIRABLE:

• 3+ years working in a research quality assurance field supporting animal health trials.
• Proficiency in the understanding of current regulatory requirements regarding the quality of research for registration of animal products in major global markets.
• Proficiency in performing quality assurance audits and inspections of non-clinical and clinical veterinary product studies and reports (including protocols, data/data listings, statistics, master study files, final study reports, clinical investigator study sites and in-phase inspections) and of facilities, CROs and processes that support those studies.

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