Quality Assurance Auditor

Celerion

Quality Assurance Auditor supporting clinical research at Celerion to ensure compliance with protocols and regulations. Involves auditing and maintaining quality in Data Management and Biometrics department.

Posted 6/9/2026full-timeLincoln • New York • 🇺🇸 United StatesJuniorMid-LevelWebsite

About the role

Key responsibilities & impact

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

Requirements

What you’ll need

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

Benefits

Comp & perks

Health insurance
Retirement plans
Paid time off
Flexible work arrangements

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

auditingquality assurancedata analysisCAPAdeviation evaluationclinical study report auditingprotocol auditingelectronic database capture auditingprocess improvementregulatory compliance

Soft Skills

communicationorganizational skillstime managementattention to detaildiplomacytactfulnessrelationship managementleadershipproblem-solvingmultitasking