Onsite Clinical QA Auditor – GxP & GLP/GCP Compliance

DivIHN Integration Inc; Durham (NC); On-site; USD 75,000 - 90,000; Full time

Job summary

DivIHN Integration Inc in Durham, NC, is seeking a Quality Assurance Specialist to provide oversight and auditing of clinical and preclinical studies. You will ensure compliance with Good Clinical Practices and other regulations while collaborating with technical staff.

The ideal candidate holds a Bachelor’s degree in a scientific field with at least 3 years of relevant experience. Strong skills in auditing and organizational abilities are essential for this role, based onsite in Research Triangle Park.

Qualifications

• Bachelor’s degree in a related field and 3+ years of industry experience.
• Knowledge of Good Clinical Laboratory Practice and Good Laboratory Practice regulations.
• Experience with immunogenicity assays is essential.

Responsibilities

• Audit studies, processes, and data for compliance with regulations.
• Perform in-process inspections of nonclinical study phases.
• Act as a technical resource for compliance-related issues.

Skills

Audit experience

Collaborative skills

Organizational skills

Interpersonal communication

Education

Bachelor's degree in a health care or relevant scientific field

Tools

MS Word

Excel

PowerPoint

Job description

DivIHN Integration Inc in Durham, NC, is seeking a Quality Assurance Specialist to provide oversight and auditing of clinical and preclinical studies. You will ensure compliance with Good Clinical Practices and other regulations while collaborating with technical staff.

The ideal candidate holds a Bachelor’s degree in a scientific field with at least 3 years of relevant experience. Strong skills in auditing and organizational abilities are essential for this role, based onsite in Research Triangle Park.