Clinical QA Auditor

McKesson

Quality Assurance Auditor responsible for promoting quality initiatives and conducting audits for SCRI. Ensuring compliance and improvement in clinical research quality standards.

Posted 7/10/2026full-timeRemote • Tennessee • 🇺🇸 United StatesMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in GxP Auditing, including conducting internal and vendor audits, developing risk-based audit plans, and ensuring compliance with FDA regulations and GCP. Proficient in tracking audit responses and communicating findings effectively to stakeholders.

Highest-signal resume keywords

GxP AuditingQuality Assurance AuditingFDA RegulationsGCP21 CFR Part 11

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Risk-Based Audit PlanningProcess ImprovementAudit ReportingCorrective Action TrackingSoftware Validation Principles

Soft Skills

CommunicationInterpersonal SkillsProblem-Solving

Certifications & Qualifications

Certified SQA ProfessionalRQA-Certified Quality Auditor

Industry Keywords

Regulated Clinical ResearchAudit ComplianceInspection Readiness

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Plans and conducts GxP audits (e.g., internal, vendor, site)
Develop a risk-based audit plan to determine the priorities of audit activities
Conducts interviews with key staff to assess process completion, support inspection readiness and to communicate any potential observations or process improvement opportunities
Communicates audit observations and process improvement opportunities through a written audit report distributed to the appropriate personnel
Appropriately escalates any critically identified areas of deficiency in quality and reports those to organization leadership and other appropriate stakeholders
Tracks, collects and reviews audit responses for timely and appropriate corrective action as follow-up to identified areas of non-compliance until audit closure
Other duties as assigned

Requirements

What you’ll need

Bachelor's Degree required
3+ years' work experience in a regulated clinical research environment required
Quality Assurance Auditing experience required
Work experience with FDA regulations and GCP is required
Knowledge of 21 CFR Part 11 requirements and software validation principles
Certified SQA Professional, RQA-Certified Quality Auditor or equivalent highly preferred

Benefits

Comp & perks

Comprehensive benefits to support physical, mental, and financial well-being