Remote GxP Services Consultant - GCP & Audits

Advarra; Northern (KY); Hybrid; USD 71,000 - 125,000; Full time

Benefits offered by this job

Health coverage

Paid holidays

Job summary

Advarra is seeking a Consultant, Good Practice (GxP) Services to support GxP consulting across client projects, focusing on Good Clinical Practice (GCP) for investigator sites. The role is involved in audits, assessments, quality assurance, and compliance initiatives under guidance from senior consultants.

This position offers opportunities to develop technical expertise, contribute to project deliverables, and engage in continuous learning while traveling up to 50–70% to client sites across the

Qualifications

• Bachelor’s degree in Nursing, Life Sciences, or related field.
• 3–5 years of experience in clinical research, quality assurance, regulatory compliance, or related life sciences environment.
• Ability to travel extensively.

Responsibilities

• Support consultants in delivering GxP consulting services for pharmaceutical, biotechnology, medical device, and life sciences clients.
• Assist with planning and conducting domestic audits and assessments under the direction of senior team members.
• Plans and performs independent audits with SME support.
• Supports inspection readiness activities as a co-auditor.
• Participates in mock inspections with senior consultants.
• Assists with SOP reviews and documentation.
• Develops subject matter knowledge over time.
• Collaborate with project managers and senior consultants to meet project timelines and client expectations.

Skills

Analytical skills

Problem-solving

Communication skills

Multitasking

Team collaboration

Education

Bachelor’s degree in Nursing, Life Sciences, or related field

Tools

Microsoft Office

Job description

Advarra is seeking a Consultant, Good Practice (GxP) Services to support GxP consulting across client projects, focusing on Good Clinical Practice (GCP) for investigator sites. The role is involved in audits, assessments, quality assurance, and compliance initiatives under guidance from senior consultants.

This position offers opportunities to develop technical expertise, contribute to project deliverables, and engage in continuous learning while traveling up to 50–70% to client sites across the