QA AUDITOR II

About the Role

Join us as a Quality Assurance Auditor II and enhance our clinical auditing processes by ensuring regulatory compliance and quality standards.

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 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.

Qualifications

• Bachelor’s degree or equivalent and relevant formal academic/vocational qualification.
• Previous QA experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).
• In some cases, an equivalency, consisting of a combination of appropriate education, training, and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Skills

• Thorough knowledge of GxP and appropriate regional research regulations and guidelines.
• Demonstrated proficiency and leadership in a range of project-based or internal GxP audits and vendor audits to high standards required by management.
• 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/workloads.
• Valid driver’s license and ability to qualify for and maintain a corporate credit card with a sufficient credit line for business travel.

Working Conditions and Environment

Work is performed in an office/laboratory and/or a clinical environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office equipment. Personal protective equipment required such as protective eyewear, garments, and gloves.

Physical Requirements

• 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 the upper body and neck.
• Light to moderate lifting and carrying (or otherwise moving) 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; with the 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.
• Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence.
• Ability to perform under stress.
• Ability to multi-task.
• Regular and consistent attendance.

Location: Richmond, Virginia
Employment: Contract
Worksite: On-Site
Pay Rate Range: $35-43.50/hr based on experience