Quality Assurance Auditor

Summary

Join Celerion, a leading global contract research organization, as a Quality Assurance Auditor to support our rapidly growing Early Clinical Research department. The successful candidate will have quality assurance expertise within a GCP environment and be responsible for assessing and assuring study, project, and process compliance with protocols, Controlled documents, and applicable regulations and guidelines through audits.

Requirements

• Bachelor’s degree in science, IT, business, or similar
• 2-5 years of quality/functional operations/clinical experience (GCP or GMP)
• Excellent oral and written communication skills
• Ability to manage multiple priorities within a tight schedule and a changing environment
• Excellent time management skills and ability to organize
• Attention to detail, tactful, and diplomatic
• Proficiency in using electronic data and computerized systems
• Ability to travel, as needed

Responsibilities

• Carry out auditing of study, project, and process reports, records and data; report audit findings to operations via QA audit reports; and determine acceptability of the responses and verify the corrections
• Interact with internal and external clients to discuss QA observations and study-related issues; and maintain effective and professional working relationships within and across departments in relation to study projects
• Participate in the improvement initiatives intended to improve quality, compliance of study, project data and reports; effectiveness and efficiency of the processes
• Detect quality issues and the need for CAPAs and evaluate deviations and investigations
• Assist with the preparation for and hosting of Client Audits and/or Regulatory Inspections
• Participate in the preparation, conduct and follow-up for System Audits and Vendor Audits