Compliance Specialist, Audits and Inspections, Client Audits-- fully remote!
Work Schedule Standard (Mon-Fri) Environmental Conditions Office
Job Description
Job Description At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future. What will you do in this role? As a Compliance Specialist, you will execute quality and compliance processes across the organization. Facilitates the tracking and reporting of quality and compliance activities. Maintains tools and materials and provides expertise to advance the vision of the department. Investigate and resolve issues, monitor metrics, and maintain reports and documentation associated with quality and compliance activities. Manage quality and compliance activities, ensuring they are carried out thoroughly and brought to a successful finish. Coordinate smaller projects and process/quality improvement initiatives with proven results. Communicate with representatives from other departments to ensure quality and timelines are maintained regarding compliance activities (e.g., client audits, CAPA, and procedural documents). Mentor staff and serve as a team lead for group projects or process improvement initiatives. Qualification requirements: Education requirements: Bachelor's degree in a related field or equivalent formal academic/vocational qualification 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: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years) Experience with clinical project coordination, clinical project administrator or similar experience is required. Able to go onsite to the Austin, Texas office is required. Potentially, 1-3 times per month, so must be within drivable distance to Austin, Texas. Client facing experience is preferred. Knowledge, Skills and Abilities: Excellent oral and written communication skills Strong organizational and time-management skills Solid organizational and time-management skills Firm knowledge of the clinical trial process Thorough knowledge and understanding of ICH GCP and other relevant regulations and guidelines Effective problem solving skills Strong attention to detail Ability to work independently as required Strong computer skills; ability to learn and become proficient with appropriate software Ability to multitask and prioritize competing demands/work load Demonstrated flexibility and adaptability Location: Fully remote in the US. Relocation assistance is NOT provided.
- Must be legally authorized to work in the United States without sponsorship.
- Must be able to pass a comprehensive background check, which includes a drug screening.
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.
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