Quality Assurance Auditor, DMB

Celerion • Lincoln, NE

18d • Onsite

About The Position

Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster. Celerion, a leading global contract research organization, seeks a Quality Assurance Auditor to support our rapidly growing Data Management and Biometrics department. The successful candidate will have Quality Assurance expertise within a GCP environment. This role will be located at either our Lincoln, NE or Tempe, AZ facilities.

Role: The role of the Quality Assurance Auditor is to assess and assure 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/laboratory/clinical experience
• Excellent oral and written communication skills
• Ability to organize and manage multiple priorities
• Excellent time management skills
• Attention to detail, tactful, and diplomatic
• Proficiency in using electronic data and computerized systems.
• Ability to travel, as needed

Nice To Haves

• Quality Assurance expertise within a GCP environment

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 (includes but not limited to Clinical Study Report audits, Protocol audits and Electronic Database Capture (EDC) audits).
• 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 and lead 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
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level