Clinical Quality Assurance Auditor

Thermo Fisher Scientific

Clinical QA Auditor ensuring quality standards in clinical auditing at Thermo Fisher Scientific. Conducting internal GCP audits and providing consultative support to project teams and clients.

Posted 4/23/2026full-timeRemote • 🇧🇬 BulgariaJuniorMid-LevelWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Conduct and/or lead a variety of internal and GCP audits as requested by senior management
Lead process audits and may participate as a co-auditor in more complex system audits
Perform other types of QA audits or activities (e.g. database audits, clinical study report audits, sample results tables, process improvement)
Serve as a knowledgeable resource to operational departments on audit or quality assurance subject matter
Provide GxP consultation and support to project teams and external clients
Prepare and present audit findings and/or other related information at departmental, internal operations or client meetings

Requirements

What you’ll need

Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Previous QA experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years)
Thorough knowledge of GxP, with particular expertise in GCP, as well as applicable regional research regulations and guidelines
Demonstrated proficiency and led a range of project-based or internal GxP audits and vendor audits to high standards required by management
Excellent oral and written communication skills
Strong problem-solving, risk assessment, and impact analysis abilities
Solid experience in root cause analysis
Above average negotiation and conflict management skills
Flexible and able to multi-task and prioritize competing demands/work load
Valid driver's license and ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel

Benefits

Comp & perks

Health insurance
Professional development opportunities
Flexible working hours

ATS Keywords

✓ Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

GxPGCPQA auditsroot cause analysisrisk assessmentimpact analysisprocess improvementdatabase auditsclinical study report auditsvendor audits

Soft Skills

oral communicationwritten communicationproblem-solvingnegotiationconflict managementflexibilitymulti-taskingprioritization

Certifications

Bachelor's degreerelevant formal academic qualification