Compliance Specialist- remote on the East Coast!

Work Schedule

Environmental Conditions

Job Description

What will you do in this role and a Day in the Life

Hosts Client Audits Researches and addresses issues tracks metrics and maintains reports and documentation related to quality and compliance activities.

Leads quality and compliance processes and ensures appropriate execution and completion.

Leads smaller projects and/or some process/quality improvement initiatives.

Communicates 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).

Mentors staff and serves as a team lead for group projects or process improvement initiatives.

Education 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 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.

Experience requirements:

A minimum of 1 year experience of previous client audit and/or regulatory inspection hosting experience is required.

Client hosting experience is required.

Proactive & solid communication is required.

Knowledge Skills and 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

Our Mission is to enable our customers to make the world healthier cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100000 colleagues we share a common set of values - Integrity Intensity Innovation and Involvement - working together to accelerate research solve complex scientific challenges drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific where diverse experiences backgrounds and perspectives are valued.

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Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race color religion sex sexual orientation gender identity national origin protected veteran status disability or any other legally protected status.

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