Senior Quality Assurance Auditor, BAS
Summary
Conduct comprehensive study, project, and process audits in a bioanalytical clinical research setting to ensure compliance with protocols and regulatory guidelines, serving as a client-facing quality representative in a hybrid role.
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.
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
Qualifications:
- 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.
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