QA Auditor II

Quality Assurance Auditor II

Location: Richmond, Virginia

Pay Rate: $41.00–$43.97 per hour

Education: Bachelor's Degree or Equivalent Required

Experience: 2+ years of relevant Quality Assurance experience

We are seeking an experienced Quality Assurance Auditor II to support and enhance clinical auditing processes while ensuring compliance with applicable regulatory requirements and quality standards.

This position is ideal for a QA professional who can hit the ground running , independently conduct and lead audits, provide GxP guidance, identify quality and compliance risks, and effectively communicate findings to Operations teams, subject matter experts, clients, and management.

The successful candidate will have strong knowledge of GxP regulations and research guidelines, excellent analytical skills, and demonstrated experience conducting project-based, internal, and vendor audits.

• Conduct and/or lead a variety of client, internal, GxP audits, and regulatory inspections as requested by senior management.

• Perform directed site, facility, vendor, and subcontractor audits.

• Conduct QA audits including:

• Database audits

• Clinical Study Report audits

• Sample results table audits

• Process audits

• Vendor audits

• Other quality assurance and process improvement activities

• Provide GxP consultation and quality assurance support to project teams and external clients.

• Lead process audits and participate as a co-auditor on more complex system audits.

• Evaluate audit results, identify potential compliance risks, and assess impacts.

• Prepare clear and comprehensive audit findings and related documentation.

• Present audit findings and other quality-related information to Operations staff, subject matter experts, internal teams, clients, and management.

• Serve as a knowledgeable resource to operational departments regarding audit practices and quality assurance requirements.

• Support continuous improvement initiatives and identify opportunities to strengthen quality processes.

• Apply root cause analysis and risk assessment techniques to quality issues.

• Work collaboratively with cross-functional teams to resolve audit findings and quality concerns.

• Perform additional QA activities as assigned.

• Bachelor's degree or equivalent relevant academic/vocational qualification.

• 2+ years of previous Quality Assurance experience or comparable experience providing the knowledge and skills required for the position.

• Demonstrated experience conducting and/or leading project-based, internal GxP, and vendor audits.

• Thorough knowledge of GxP requirements and applicable regional research regulations and guidelines.

• Strong understanding of quality systems and clinical research processes.

• Experience preparing, documenting, and presenting audit findings.

• Strong problem-solving, risk assessment, and impact analysis abilities.

• Demonstrated experience with root cause analysis.

• Excellent written and verbal communication skills.

• Strong negotiation and conflict-management skills.

• Ability to work independently and manage multiple priorities.

• Flexible and adaptable in a changing work environment.

• Valid driver's license and ability to qualify for and maintain a corporate credit card with sufficient credit for business travel.

Equivalent combinations of education, training, and directly related experience may be considered in lieu of specific requirements where applicable.

• Strong knowledge of GxP regulations and relevant research guidelines.

• Proven ability to conduct high-quality audits with limited supervision.

• Excellent attention to detail and documentation skills.

• Strong organizational and time-management abilities.

• Ability to communicate effectively with diverse groups, including Operations…