Compliance Specialist, Audits and Inspections, Client Audits
Thermo Fisher Scientific
full-time
Posted on:
Location Type: Hybrid
Location: Remote • Texas • United States
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Tech Stack
About the role
- Execute quality and compliance processes across the organization
- Facilitate the tracking and reporting of quality and compliance activities
- Maintain tools and materials and provide 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
- 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 (1-3 times per month)
- Client facing experience is preferred
- 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
Benefits
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical project coordinationclinical project administrationquality and compliance processesmetrics monitoringreport documentationprocess improvementCAPAICH GCPproblem solvingattention to detail
Soft Skills
oral communicationwritten communicationorganizational skillstime-management skillsindependencemultitaskingprioritizationflexibilityadaptabilitymentoring
Certifications
Bachelor's degreeclinical trial certification