QA Clinical Auditor II

• Conduct and/or lead client, internal, GCP, site, facility, vendor, and subcontractor audits
• Participate in regulatory inspections as requested by senior management
• Provide GCP consultation and support to project teams and external clients
• Lead process audits and co-audit complex system audits
• Perform QA activities including database audits, clinical study report audits, sample results tables, and process improvement
• Serve as a QA and audit subject-matter resource to operational departments
• Prepare and present audit findings and related information in departmental, operations, and client meetings
• Work in office, laboratory, and/or clinical environments
• Use required personal protective equipment and handle potential exposure to biological fluids and infectious organisms

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• 2+ years of previous QA experience
• Thorough knowledge of GCP and appropriate regional research regulations and guidelines
• Demonstrated proficiency in project-based or internal GCP audits and vendor audits
• Excellent oral and written communication skills
• Strong problem-solving, risk assessment, and impact analysis abilities
• Experience in root cause analysis
• Negotiation and conflict management skills
• Ability to multitask and prioritize competing demands/workload
• Valid driver's license
• Ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel
• Ability to work in an upright and/or stationary position for 6–8 hours per day
• Ability to perform frequent mobility, bending, twisting, crouching, and stooping
• Ability to lift and carry 15–20 lbs
• Ability to access and use computer software
• Regular and consistent attendance

• Global team environment
• Collaboration and development opportunities
• Commitment to scientific excellence