QA Auditor II

What You’ll Do

• 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.

Education and Experience

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.

Knowledge, Skills and Abilities

• Thorough knowledge of GxP and appropriate regional research regulations and guidelines.
• Demonstrated proficiency in leading 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/work load.
• Valid driver’s license and ability to qualify for and maintain a corporate credit card with 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, and 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 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 lb.
• 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; strong listening skills.
• Frequent interaction with diverse groups to obtain or relate information.
• Perform a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability.
• Ability to perform under stress, multi‑task, maintain regular and consistent attendance.

Pay

Pay Rate Range: $35‑43.50/hr based on experience.