QA Auditor II- remote anywhere in the US!

Employer Industry: Clinical Research

Why Consider This Job Opportunity
• Opportunity for career advancement and growth within the organization
• Competitive salary with potential bonuses
• Supportive and collaborative work environment
• Chance to make a significant impact on the quality and integrity of clinical research programs
• Opportunities for professional development through mentoring and training

What To Expect (Job Responsibilities)
• Conduct complex internal and external Clinical Research Site audits to ensure compliance with established quality assurance processes and regulations
• Identify issues affecting the quality of clinical research programs and develop strategies to address them
• Perform technical document reviews and support clinical development programs
• Provide audit reports to management and lead quality improvement initiatives
• Mentor peers and develop tools for tracking compliance management activities

What Is Required (Qualifications)
• Bachelor's degree or equivalent in a relevant field
• Minimum of 2+ years of Clinical Site Auditing experience
• Must have GCP and auditing experience for clinical trials
• Thorough knowledge of applicable GCP and regional regulations
• Excellent oral and written communication skills with strong attention to detail

How To Stand Out (Preferred Qualifications)
• Experience hosting client audits and/or regulatory inspections
• Familiarity with auditing databases, eTMF, and Clinical Study Reports
• Background in training and mentoring peers
• Strong problem-solving skills and risk assessment abilities
• Experience with study-specific audits or other GP audits

#ClinicalResearch #QualityAssurance #CareerOpportunity #ProfessionalDevelopment #Auditing

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