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. With a large clinical capacity of more than 600 beds, efficient bioanalytical laboratories, and experienced scientific staff, Celerion offers one of the most experienced clinical pharmacology research networks in the industry.
Are you looking for an opportunity to be involved in creating life-saving treatments? If so, we can't wait to meet you!
Celerion is seeking a Quality Assurance Auditor to support our Early Clinical Research (ECR), Global Clinical Development (GCD) and Data Management and Biostatistics (DMB) departments. The successful candidate will have quality assurance expertise within a GCP environment. This role is located at our Lincoln, NE facility.
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.
- 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 Study Source Data Audits, Trial Master File audits, Database audits, Clinical Study Report audits).
- Review deviations, investigations, and change control documentation; and assess acceptability of the content and documentation.
- Maintain QA files and QA audit reports.
- 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.
- Perform other functions as assigned by Quality Assurance Management.
- 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 assist Quality Assurance Management with the QI/CAPA process
- Assist with the preparation for and hosting of client audits and/or regulatory inspections.
- Participate in the preparation, execution and follow up for System Audits, Vendor Audits, Non-Celerion Site Audits
Education and Qualifications:
- Bachelor’s degree in science, IT, business, or similar
- 2-5 years quality/ functional operations/GCP experience
- Working knowledge of applicable Clinical, Data Management and External Site Services function regulations and guidances (GCP/GLP/cGMP/GDP E-records & E-signatures) regulations and related guidelines
- Excellent oral and written communication skills
- Ability to organize and manage multiple priorities
- Excellent time management skills
- Attention to detail, tactful, and diplomatic
- Proficiency with Microsoft Office and general computer knowledge
- Ability to travel, as needed
Are you ready to join our team?
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.