Clinical Auditing Specialist II Vendors and Information System Audits
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Job Location:
Wilmington, DE - USA
Monthly Salary:
Not Disclosed
Posted on:
11 hours ago
Vacancies:
1 Vacancy
Job Summary
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
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 Youll 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:
Bachelors 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 drivers 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. Youll 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 tomorrows breakthrough.
Required Experience:
IC
Key Skills
- Computer Science
- Active Directory
- Clearance
- Facility
- HVAC
- Linux
- Project Management
- Troubleshoot
- Desktop
- Control Systems
- Management System
- Setup
- hardware
- Data Analysis
- Technical Support
About Company
Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more
