Senior QA Auditor - Client-Facing GLP/GCP Compliance

Socket.dev; Lincoln (NE); Hybrid; USD 65,000 - 90,000; Full time

Job summary

Celerion is seeking a Quality Assurance Auditor to join our rapidly expanding Bioanalytical department. In this client-facing role, you’ll ensure the integrity of studies that advance breakthrough therapies from laboratory to patient.

This hybrid Lincoln, NE position requires 1-3 days onsite and candidates within commuting distance. The ideal candidate has lab/GLP/GCP experience, strong communication skills, and attention to detail essential for client-facing responsibilities.

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.

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

Skills

Quality auditing

GLP/GCP experience

Client-facing communication

Attention to detail

Time management

Education

Bachelor's degree in science/IT/business or similar

Job description

Celerion is seeking a Quality Assurance Auditor to join our rapidly expanding Bioanalytical department. In this client-facing role, you’ll ensure the integrity of studies that advance breakthrough therapies from laboratory to patient.

This hybrid Lincoln, NE position requires 1-3 days onsite and candidates within commuting distance. The ideal candidate has lab/GLP/GCP experience, strong communication skills, and attention to detail essential for client-facing responsibilities.