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
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