QA Auditor II

Job Description

Job Summary:

• Conduct QA audits such as database audits, clinical study report audits, sample results tables, etc.
• Serve as a knowledgeable resource on audit or quality assurance subject matter.
• Prepare and present audit findings and/or other related information to Operations staff and SMEs.
• Join us as Quality Assurance Auditor II – And enhance our clinical auditing processes by ensuring regulatory compliance and quality standards.

Duties and Responsibilities:

• Conduct and/or lead a variety of client, internal or GxP audits and regulatory inspections as requested by senior management.
• Perform directed site audits, facility, vendor and/or sub-contractor audits.
• Provide GxP consultation and support to project teams and external clients.
• Lead process audits and may participate as a co-auditor in more complex system audits.
• Perform other types of QA audits or activities (e.g., database audits, clinical study report audits, sample results tables, process improvement).
• Serve as a knowledgeable resource to operational departments on audit or quality assurance subject matter.
• Prepare and present audit findings and/or other related information at departmental, internal operations or client meetings.

Knowledge, Skills, and Abilities:

• Thorough knowledge of GxP and appropriate regional research regulations and guidelines.
• Demonstrated proficiency and led a range of project-based or internal GxP audits and vendor audits to high standards required by management.
• Excellent oral and written communication skills.
• Strong problem solving, risk assessment and impact analysis abilities.
• Solid experience in root cause analysis.
• Above average negotiation and conflict management skills.
• Flexible and able to multi-task and prioritize competing demands/workload.
• Valid driver’s license and ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel.