What are the responsibilities and job description for the Quality Assurance Auditor, ECR position at Celerion?
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.
Are you looking for an opportunity to be involved in creating life-saving treatments? If so, we can't wait to meet you!
Celerion, a leading global contract research organization, seeks a Quality Assurance Auditor to support our rapidly growing Early Clinical Research department. The successful candidate will have quality assurance expertise within a GCP environment. This full-time position can be based at our Lincoln, NE or Phoenix, AZ facilities, with the ability to work from home occasionally.
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.
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.
- 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 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 and investigations.
- 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/functional operations/clinical experience (GCP or GMP)
- Excellent oral and written communication skills
- Ability to manage multiple priorities within a tight schedule and a changing environment
- Excellent time management skills and ability to organize
- Attention to detail, tactful, and diplomatic
- Proficiency in using electronic data and computerized systems
- Ability to travel, as needed
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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