QA Auditor II

This is a fully onsite role supporting our BIOA Lab in Richmond, VA. We welcome applicants from all locations within the US. Must be legally authorized to work in the United States without sponsorship and able to pass a comprehensive background check, including a drug screening.

About the role

Join our PPD® Laboratory Services team as a Quality Assurance Auditor II and enhance our clinical auditing processes by ensuring regulatory compliance and quality standards. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations that improve patient health.

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

Requirements

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous QA experience (comparable to 2+ years) or an equivalency consisting of a combination of appropriate education, training, and/or directly related experience
• Valid driver's license and ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel
• Ability to work in an upright and/or stationary position for 6-8 hours per day
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists
• Frequent mobility required
• Occasional crouching, stooping, with frequent bending and twisting of upper body and neck
• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs
• Ability to access and use a variety of computer software developed both in-house and off-the-shelf
• Ability to communicate information and ideas so others will understand; ability to listen to and understand information and ideas presented through spoken words and sentences
• Frequently interacts with others to obtain or relate information to diverse groups
• Ability to perform under stress and multi-task
• Regular and consistent attendance
• Ability to lift 40 lbs without assistance

Skills

• Thorough knowledge of GxP and appropriate regional research regulations and guidelines
• Demonstrated proficiency and experience leading a range of project-based or internal GxP audits and vendor audits to high standards
• 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

Environmental Conditions

• Office and laboratory setting
• Exposure to biological fluids with potential exposure to infectious organisms
• Exposure to electrical office equipment
• Cold Room/Freezers (-22°F / -6°C)
• Work with hazardous/toxic materials
• Personal protective equipment required (safety glasses, gowning, gloves, lab coat, ear plugs, etc.)