Quality Assurance Auditor II

We are hiring Quality Assurance Auditor II.

Client:
Major Clinical Research Client

Position:
Quality Assurance Auditor II

Duration: 3+ months on W2

Pay Rate: $38.00-$44.00/ Hr on W2

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Schedule: Monday–Friday | First Shift

We are seeking an experienced Quality Assurance Auditor II who can quickly integrate into the team and independently support GxP auditing activities.

• Conduct Quality Assurance audits, including database audits, clinical study report audits, sample results table reviews, and other GxP-related audits.
• Lead and/or perform client, internal, vendor, facility, site, and subcontractor audits in accordance with regulatory requirements.
• Support regulatory inspections and ensure compliance with applicable GxP standards.
• Provide GxP consultation and quality assurance guidance to project teams and stakeholders.
• Lead process audits and participate as a co-auditor on complex system audits.
• Identify process improvement opportunities through QA activities and audit findings.
• Serve as a subject matter resource for operational departments on quality assurance and audit-related topics.
• Prepare comprehensive audit reports and present findings to internal teams and stakeholders.

• Bachelor’s degree or an equivalent combination of relevant education and professional experience.
• Minimum of 2+ years of Quality Assurance experience in a GxP-regulated environment.
• Equivalent combinations of education, training, and directly related experience may be considered.

• Thorough knowledge of GxP regulations and regional clinical research guidelines.
• Proven experience leading project-based, internal, and vendor GxP audits.
• Strong understanding of regulatory compliance and quality systems.
• Excellent written and verbal communication skills.
• Strong problem-solving, risk assessment, and impact analysis capabilities.
• Experience conducting root cause analysis and developing corrective actions.
• Effective negotiation and conflict resolution skills.
• Ability to manage multiple priorities in a fast-paced environment.
• Valid driver’s license and ability to travel for business as needed.