Compliance Specialist, Audits and Inspections, Client Audits-- fully remote!

About the position 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.

Responsibilities

• 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.

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.
• 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.
• 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
• 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.

Nice-to-haves

• Client facing experience is preferred.

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