Celerion
Celerion1d ago
New

Senior Quality Assurance Auditor, BAS

United StatesUnited States·LincolnFull-Timesenior
OtherQuality Assurance
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Overview

Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility,

Technical Tools
OtherQuality Assurance
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.  

We're seeking a Quality Assurance Auditor to join our rapidly expanding Bioanalytical department. In this client-facing role, you'll play a critical part in ensuring the integrity of studies that advance breakthrough therapies from laboratory to patient.
 
The Role As a Quality Assurance Auditor, you will conduct comprehensive audits to ensure study, project, and process compliance with protocols, controlled documents, and applicable regulatory guidelines. You'll build strong relationships with client teams while serving as a trusted representative of our organization's commitment to quality and compliance.
 
Work Arrangement This hybrid position is based at our Lincoln, NE, facility, requiring 1-3 days onsite, depending on audit requirements. We are only considering candidates within commuting distance of Lincoln, NE.
 
What We're Looking For The ideal candidate brings experience in laboratory and/or GLP/GCP environments, along with strong communication skills and attention to detail essential for client-facing 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 Protocol Audits, Raw Data and Report audits, and Process 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
  • Bachelor’s degree in science, IT, business, or similar
  • 2-5 years of quality/laboratory experience
  • Excellent oral and written communication skills; ability to build strong client relationships
  • 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 
  • Possess a Quality by design mindset, willing to dig deeper by asking questions
  • Celerion Values:       Integrity   Trust   Teamwork   Respect
     
    Celerion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, genetic information, marital status, qualified protected veteran status, or disability.
     

    Note: To make sure you don't miss important updates from us, please check your Spam folder for emails from @celerion.com, particularly interview invitations. If you find one there, mark it as "Not Junk" to ensure future Celerion emails land in your inbox. Please note that Gmail accounts have been particularly noted as routing to Spam.

     

    Location & Eligibility

    Where is the job
    Lincoln, United States
    Hybrid — some on-site time required
    Who can apply
    US

    Listing Details

    Posted
    August 21, 2026
    First seen
    August 21, 2026
    Last seen
    August 22, 2026

    Posting Health

    Days active
    0
    Repost count
    0
    Trust Level
    70%
    Scored at
    August 21, 2026

    Signal breakdown

    freshnesssource trustcontent trustemployer trust
    Celerion

    Celerion is a leading Clinical Research Organization focused on accelerating early phase drug development through innovative strategies and comprehensive research services.

    Employees
    3k+
    Founded
    2010
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    CelerionSenior Quality Assurance Auditor, BAS