
Senior Compliance Specialist
Thermo Fisher Scientific
full-time
Posted on:
Location Type: Remote
Location: North Carolina • United States
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Job Level
Tech Stack
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