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QA Auditor II
Thermo Fisher Scientific. Conduct and/or lead client, internal, GCP, directed site, facility, vendor, and subcontractor audits and regulatory inspections .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in GCP compliance and quality assurance processes, with a strong ability to conduct audits and provide consultation to project teams and clients. Proficient in risk assessment, problem solving, and effective communication in diverse environments.
Highest-signal resume keywords
GCP ComplianceQuality Assurance ExperienceAudit LeadershipRoot Cause AnalysisExcellent Communication Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
GCP KnowledgeAudit ConductingDatabase AuditsClinical Study Report AuditsProcess Improvement
Soft Skills
Problem SolvingRisk AssessmentNegotiation SkillsConflict ManagementMultitasking
Tools & Technologies
In-House SoftwareOff-the-Shelf Software
Certifications & Qualifications
Bachelor's Degree or Equivalent
Industry Keywords
Regulatory InspectionsVendor AuditsClinical EnvironmentsBiological Fluids ExposureInfectious Organisms
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Conduct and/or lead client, internal, GCP, directed site, facility, vendor, and subcontractor audits and regulatory inspections
- Provide GCP consultation and support to project teams and external clients
- Participate as a co-auditor in complex system audits
- Perform QA activities including database audits, clinical study report audits, sample results table audits, and process improvement
- Serve as a QA and audit subject-matter resource to operational departments
- Prepare and present audit findings and related information at departmental, internal operations, and client meetings
- Work in office, laboratory, and/or clinical environments
- Handle potential exposure to biological fluids, infectious organisms, and electrical office equipment while using required personal protective equipment
- Work with varied demands, changing conditions, physical activity, and frequent interactions with diverse groups
Requirements
What you’ll need- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- 2+ years of previous QA experience
- Equivalency through a combination of appropriate education, training and/or directly related experience may be considered sufficient
- Thorough knowledge of GCP and appropriate regional research regulations and guidelines
- Proficiency leading project-based or internal audits and vendor audits
- Excellent oral and written communication skills
- Strong problem solving, risk assessment and impact analysis abilities
- Experience in root cause analysis
- Negotiation and conflict management skills
- Ability to multitask and prioritize competing demands/workload
- Valid driver's license
- Ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel
- Ability to access and use in-house and off-the-shelf computer software
- Regular and consistent attendance
Benefits
Comp & perks- Global team environment
- Collaboration and development opportunities
- Scientific excellence-focused workplace