Clinical Quality Assurance Specialist

Clinical QA Auditor (GxP / Clinical)

Location: Richmond, VA 23230

Employment Type: Contract, 3 months (W2)

Role Summary

We are looking for a Quality Assurance Auditor to strengthen our clinical auditing processes and ensure regulatory compliance and quality standards. You will conduct and lead GxP audits, advise project teams, and present findings to operations staff and subject matter experts.

Key Responsibilities

• Conduct and lead client, internal, and GxP audits and support regulatory inspections as directed by senior management
• Perform site, facility, vendor, and subcontractor audits
• Lead process audits and act as co-auditor on complex system audits
• Perform other QA activities, including database audits, clinical study report (CSR) audits, sample results table reviews, and process improvement initiatives
• Provide GxP consultation to project teams and external clients
• Serve as a go-to resource on audit and quality assurance topics
• Prepare and present audit findings at departmental, internal, and client meetings
• Support root cause analysis, risk assessment, and impact analysis for audit findings

Qualifications

• Bachelor’s degree or equivalent combination of education, training, and experience
• 2+ years of QA experience in a GxP-regulated environment
• Thorough knowledge of GxP regulations and applicable regional guidelines (e.g., ICH-GCP, FDA, EMA)
• Demonstrated experience leading internal, project-based, and vendor audits
• Solid root cause analysis skills
• Strong risk assessment and problem-solving abilities
• Excellent written and verbal communication
• Strong negotiation and conflict management skills
• Ability to multitask and prioritize competing demands
• Valid driver’s license and ability to maintain a corporate credit card for business travel

Working Conditions and Physical Requirements

• Office, laboratory, and/or clinical environment; potential exposure to biological fluids and infectious organisms; PPE required (eyewear, garments, gloves)
• Ability to remain stationary 6-8 hours per day; frequent mobility; occasional crouching and stooping
• Lift and carry up to 15-20 lbs (luggage, laptop)
• Proficiency with in-house and off-the-shelf software
• Ability to work under pressure with shifting priorities; regular and consistent attendance