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The Compliance Specialist will host client audits, research and address issues, and maintain reports related to quality and compliance activities. They will also lead quality and compliance processes and mentor staff on group projects.
Candidates should have a Bachelor's degree and at least 1 year of experience in client audit hosting. Strong communication skills and knowledge of ICH GCP regulations are essential.
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job 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. Accessibility/Disability Access Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process. *This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response. Thank you for your interest as you consider starting a new career journey with us. As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers. Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer. Their work is a story of purpose. What story will you tell? Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. COVID-19 Vaccination Update for U.S. & Canada Colleagues All U.S. colleagues are required to disclose their COVID-19 vaccination status. New hires will be asked to disclose their vaccination status upon the first day of employment. U.S. new hires (including those in Field Sales, Field Services and Customer Support - Technical Applications) may be required to be vaccinated against COVID-19, including boosters, based on the customer or client sites they visit and support. Individuals may also be required to comply with other COVID-19 health and safety protocols, such as masking or testing. U.S. and Canada new hires in Clinical Research who are in the following job categories must be fully vaccinated before their first day of employment or request an accommodation: executive director level and above, client-facing commercial, clinical research associates (CRAs), Assistant CRA (ACRAs), all CRA and ACRA line managers, clinic-based staff in early development services and accelerated enrollment solutions, and FSP within analytical services division roles. Canada new hires (including those in Field Sales, Field Services, and Customer Support Technical Applications) may be required to be vaccinated against COVID-19, including boosters, based on the customer or client sites they visit and support. Individuals may also be required to comply with other COVID-19 health and safety protocols, such as masking or testing. New hires in Field Sales, Field Services, and Customer Support Technical Applications will be asked to disclose their vaccination status upon the first day of employment. 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. Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.
This job posting was last updated on 8/20/2025