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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