Quality Assurance Auditor II

Radiant Systems Inc; Richmond (VA); On-site; USD 52,000 - 61,000; Full time

Job summary

Radiant Systems Inc. is seeking an experienced Quality Assurance Auditor II to rapidly integrate with the team and independently support GxP auditing activities in a Richmond, VA area role.

The candidate will conduct comprehensive QA audits, lead client and vendor audits, and support regulatory inspections while ensuring compliance with GxP standards. Strong communication and root-cause analysis skills are essential.

Qualifications

• Bachelor’s degree or equivalent in a related field.
• Minimum 2+ years of QA experience in a GxP-regulated environment.
• Experience leading audits and audit reports.

Responsibilities

• Conduct QA audits: database, clinical study report, sample review, and other GxP audits.
• Lead or perform audits of clients, internal teams, vendors, facilities and sites.
• Support regulatory inspections and ensure GxP compliance.
• Provide QA guidance to project teams and stakeholders.
• Lead process audits and co-audit complex system audits.

Skills

GxP regulations

Regulatory compliance

Quality systems

Audit leadership

Communication skills

Root cause analysis

Travelable

Documentation

Risk assessment

Team collaboration

Education

Bachelor’s degree or equivalent

2+ years QA in GxP

Job description

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

___________________________________________________________________________________________

Job Description

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.

Key Responsibilities

• 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.

Education & Experience

• 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.

Required Knowledge, Skills & Abilities

• 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.