Compliance Specialist- remote on the East Coast!
Thermo Fisher Scientific
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Whether our customers are accelerating life sciences research, solving sophisticated analytical challenges, improving patient diagnostics and therapies or growing efficiency in their laboratories, we are here to support them. Our distributed team of more than 100,000 colleagues delivers an outstanding combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific.
This is a fully remote role on the east coast, ideally in the RTP or Wilmington, NC locations! Ideal candidate will be located on the east coast, due to this is where our clients and audits will mainly take place.
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:
Bachelor's 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 100,000+ 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.
Apply today! http://jobs.thermofisher.com
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.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
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