Sr Compliance Specialist
Morrisville, NC - USA
Job Summary
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
The Senior Compliance Specialist executes quality and compliance strategies and initiatives across the organization and manages the tracking and reporting of quality and compliance activities. The role involves maintaining tools and materials serving as project lead and providing mentoring and expertise to advance the vision of the department.
What Youll Do:
Research and addresses issues track metrics and maintain reports and
documentation related to quality and compliance activities.
Lead quality and compliance processes and ensure appropriate execution and completion.
Lead smaller projects and/or some process/quality improvement initiatives.
Communicate with representatives from other departments to ensure quality and timelines are maintained with respect to compliance activities (e.g. client audits CAPA and/or procedural documents).
Mentor staff and serve as a team lead for group projects or process improvement initiatives.
Education & Experience Requirements:
Bachelors degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge skills and abilities to perform the job (comparable to 5 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 Abilities:
Excellent oral and written communication skills
Strong organizational and time-management skills
Extensive knowledge of the clinical trial process
Comprehensive knowledge and understanding of ICH GCP and other relevant regulations and guidelines
Demonstrated problem solving skills
Excellent attention to detail
Strong computer skills; ability to learn and become proficient with appropriate software
Demonstrated ability to multitask and prioritize competing demands/work load
Proven flexibility and adaptability
Working Conditions and Environment:
Work is performed in an office environment with exposure to electrical office equipment.
Occasional drives to site/office locations with occasional travel both domestic and international
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 experienceand where your contributions truly make a difference.
Apply today to help us deliver tomorrows breakthroughs.
Required Experience:
Senior IC
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