Celerion
Clinical Research
QualityAssuranceAuditor
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Quality Assurance Auditor at Celerion. Skills: Quality Assurance, Auditing, GCP environment. Audit study, project, and process reports. Report audit findings to operations”
Industry & Context.
Ability to travel
What They're Looking For.
Must Have
2-5 years quality/laboratory/clinical experience, Proficiency in using electronic data and computerized systems, Ability to travel, as needed
What You'll Do.
Report audit findings to operations
Determine acceptability of responses
Interact with internal and external clients
Discuss QA observations
Maintain professional working relationships
Participate in improvement initiatives
Lead improvement initiatives
Detect quality issues
Detect need for CAPAs
Assist with preparation for client audits
Assist with hosting client audits
Participate in preparation for System Audits
Participate in conduct of System Audits
Participate in follow-up for System Audits
Participate in preparation for Vendor Audits
Participate in conduct of Vendor Audits
Participate in follow-up for Vendor Audits
How You'll Work.
Team & Collaboration
Within and across departments
Communication Scope
Oral communication; Written communication
Full Job Description
## Description 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. Are you looking for an opportunity to be involved in creating life-saving treatments? If so, we can't wait to meet you! 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. ## 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 ## Qualifications Bachelor’s degree in science, IT, business, or similar 2-5 years of quality/laboratory/clinical expe
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