[Hiring] Compliance Specialist, Audits and Inspections, Client Audits @Thermo Fisher Scientific

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Role Description

As a Compliance Specialist, you will execute quality and compliance processes across the organization. Your responsibilities will include:
• Facilitating the tracking and reporting of quality and compliance activities
• Maintaining tools and materials and providing expertise to advance the vision of the department
• Investigating and resolving issues, monitoring metrics, and maintaining reports and documentation associated with quality and compliance activities
• Managing quality and compliance activities, ensuring they are carried out thoroughly and brought to a successful finish
• Coordinating smaller projects and process/quality improvement initiatives with proven results
• Communicating with representatives from other departments to ensure quality and timelines are maintained regarding compliance activities (e.g., client audits, CAPA, and procedural documents)
• Mentoring staff and serving as a team lead for group projects or process improvement initiatives

Qualifications
• Bachelor's degree in a related field or equivalent formal academic/vocational qualification
• 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 1-3 times per month, so must be within drivable distance to Austin, Texas
• Client facing experience is preferred

Requirements
• Excellent oral and written communication skills
• Strong 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

Benefits
• 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

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