Clinical Auditing Specialist II - Vendors and Information System Audits
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Join us as Quality Assurance Auditor II (Service Provider Audits Team) and enhance our clinical auditing processes by ensuring regulatory compliance and quality standards. 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 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 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.
- 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. Apply tot his job Apply To this Job