Clinical Auditing Specialist II - Vendor and Information System Audits Team

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join us as Quality Assurance Auditor II (Technology Solution Audits Team) and enhance our clinical auditing processes by ensuring regulatory compliance and quality standards.

What You’ll Do:

• Conduct and/or lead external supplier GxP information systems audits as requested by senior management, including but not limited to on-site, virtual, questionnaire, or desktop audits of technology solutions used in clinical trials

• Assess processes related to computerized systems used in clinical trials, including Quality Management Systems (QMS), System Development Life Cycle (SDLC), information security, data integrity, business continuity, disaster recovery, backup and restore, and data center and/or cloud hosting environments.

• Provide GxP regulatory consultation and support to internal project teams and stakeholders on information systems compliance requirements, including but not limited to 21 CFR Part 11 and applicable EMA guidelines for computerized systems used in clinical trials.

• Prepare, document, and issue audit reports and observations to departmental and cross-functional stakeholders

• Contribute to team’s Practical Process Improvement (PPI) efforts

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 for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

• Thorough knowledge of GxP and appropriate regional research regulations and guidelines

• Demonstrated proficiency and led a range of GxP audits to high standards required by management

· Working knowledge or familiarity with GAMP 5 R2, computer system validation concepts, 21CFR Part 11 Compliance, and the software development lifecycle (SDLC).

· 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.

• 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 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; 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.

Why Join Us?
When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience – and where your contributions truly make a difference.

Apply today to help us deliver tomorrow’s breakthrough.