Thermo Fisher Scientific

Senior Compliance Specialist

Thermo Fisher Scientific

full-time

Posted on:

Location Type: Remote

Location: North CarolinaUnited States

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Job Level

About the role

  • Research and addresses issues, track metrics and maintain reports and documentation related to quality and compliance activities.
  • Lead quality and compliance processes and ensure appropriate execution and completion.
  • Lead smaller projects and/or some process/quality improvement initiatives.
  • Communicate 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).
  • Mentor staff and serve as a team lead for group projects or process improvement initiatives.

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 5+ years).
  • 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
Benefits
  • Health insurance
  • 401(k) matching
  • Flexible working hours
  • Paid time off
  • Professional development opportunities
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
quality assurancecompliance managementprocess improvementmetrics trackingreportingclinical trial processICH GCPCAPAproblem solvingattention to detail
Soft Skills
communicationorganizational skillstime managementmentoringmultitaskingprioritizationflexibilityadaptability
Certifications
Bachelor's degreevocational qualification