Senior Quality Assurance Auditor, BAS

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.

About 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.

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.

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.

Requirements

• 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