Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

Job Title: Clinical Auditing Specialist 2

Summarized Purpose: The Clinical Auditing Specialist is responsible for conducting complex internal and/or external audits to ensure compliance with established quality assurance processes, standards, global regulatory guidelines, and client contractual obligations. The role involves identifying issues impacting quality and/or regulatory compliance, supporting the determination of root causes of non-conformance, and assisting in developing strategies to address these issues. Additionally, the auditor may perform technical document reviews and other GxP activities in support of project work or company processes. The auditor will provide finished audit reports to management and plan and deliver billable quality services for clients and projects.

• Conducts and/or leads a variety of client, internal or GxP audits and regulatory inspections as requested by senior management.
• Performs directed site audits, facility, vendor, and/or sub-contractor audits.
• Provides GxP consultation and support to project teams and external clients.
• Leads process audits and may participate as a co-auditor in more complex system audits.
• Performs other types of QA audits or activities (e.g., database audits, clinical study report audits, sample results tables, process improvement).
• Serves as a knowledgeable resource to operational departments on audit or quality assurance subject matter.
• Prepares and presents audit findings and/or other related information at departmental, internal operations, or client meetings.

• Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.

• Developing professional expertise, applies company policies and procedures to resolve a variety of issues.

• Normally receives general instructions on routine work, detailed instructions on new projects or assignments. Exercises judgment within defined procedures and practices to determine appropriate action.

• Contacts are primarily internal to the company with infrequent external customer/vendor contact on routine matters. Builds productive internal/external working relationships.

• 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').

• Thorough knowledge of GxP and appropriate regional research regulations and guidelines.
• Demonstrated proficiency and led 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/workload.
• Valid driver's license and ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel.

• No management responsibility.

• 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.

• 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 a 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.