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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