QA Auditor II
Thermo Fisher Scientific Inc
Quality Assurance Auditor II role at Thermo Fisher Scientific's BIOA Lab in Richmond, Virginia, supporting clinical research operations. Conduct GxP audits, regulatory inspections, and quality assurance activities across internal and external sites while ensuring compliance with research standards.
Responsibilities
- Conduct and lead client, internal, and regulatory GxP audits and inspections
- Perform site, facility, vendor, and sub-contractor audits as directed
- Provide GxP consultation and support to project teams and external clients
- Prepare and present audit findings and related information to departmental and client meetings
- Serve as subject matter expert resource on audit and quality assurance topics
Requirements
- Bachelor's degree or equivalent formal academic/vocational qualification
- 2+ years QA experience or equivalent combination of education and directly related experience
- Thorough knowledge of GxP and regional research regulations and guidelines
- Demonstrated proficiency leading project-based and vendor GxP audits
- Strong written and oral communication skills
- Root cause analysis and risk assessment expertise
- Valid driver's license and ability to qualify for corporate credit card
Vacancy posted 2 days ago
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