Senior Quality Assurance Auditor

Clario

. Plan, conduct, lead, and report internal, external, vendor/supplier, customer, registrar, and regulatory audits in accordance with applicable Standard Operating Procedures (SOPs) and electronic document management system processes .

Posted 10/19/2026full-timeRemote • Pennsylvania • United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Quality Assurance processes, including conducting audits, managing CAPAs, and ensuring compliance with regulatory standards. Proficient in developing SOPs and providing training while effectively collaborating with cross-functional teams to enhance quality management systems.

Highest-signal resume keywords

Quality AssuranceAuditingGood Clinical Practice (GCP)Quality Management Systems (QMS)ASQ Auditor Certification

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

AuditingQuality AssuranceRoot Cause AnalysisCorrective and Preventive Actions (CAPAs)Software ValidationCompliance ReportingDocument ManagementQuality Metrics TrackingSOP DevelopmentValidation Deliverables Review

Soft Skills

Problem-SolvingOrganizational SkillsInterpersonal SkillsWritten CommunicationVerbal Communication

Tools & Technologies

Microsoft WordMicrosoft ExcelElectronic Document Management Systems

Certifications & Qualifications

ASQ Auditor CertificationAuditor Training

Industry Keywords

Clinical TrialsPharmaceuticalBiotechnologyContract Research Organization (CRO)21 CFR Part 11ICH GuidelinesElectronic RecordsElectronic Signatures

Tech Stack

Tools & technologies

SDLC

About the role

Key responsibilities & impact

Plan, conduct, lead, and report internal, external, vendor/supplier, customer, registrar, and regulatory audits in accordance with applicable Standard Operating Procedures (SOPs) and electronic document management system processes
Manage and monitor audit findings, quality events, corrective and preventive actions (CAPAs), root cause activities, and effectiveness checks through timely closure, escalating significant quality concerns when appropriate
Track and trend audit activities, compliance reports, CAPAs, and quality metrics, communicating significant trends and risks to management
Perform Quality Assurance reviews of source documents, case report forms (CRFs), reports, and system development and validation deliverables for accuracy, consistency, and compliance
Partner with development and cross-functional teams to identify compliance risks, resolve quality issues, and implement process improvements, with particular focus on the audit program and Quality Management System
Provide quality-related guidance and training to colleagues, support root cause analysis, and mentor personnel as assigned
Develop or revise SOPs, support departmental and regulatory standards, and maintain current technical and industry knowledge through applicable training

Requirements

What you’ll need

Associate’s degree or equivalent required, preferably in life sciences, clinical trials, quality management, computer science, or a related field
Quality or quality systems certification, such as ASQ Auditor certification or auditor training, or equivalent experience
5+ years of relevant experience in Quality Assurance, auditing, validation, and/or software development lifecycle (SDLC) systems within a regulated industry, preferably pharmaceutical, contract research organization (CRO), biotechnology, or medical device
Strong working knowledge of Good Clinical Practice (GCP), ICH Guidelines, software validation requirements, Quality Management Systems (QMS), 21 CFR Part 11, Annex 11, and applicable electronic records and electronic signatures regulations
Demonstrated leadership experience, including supporting, guiding, or mentoring colleagues
Strong problem-solving, documentation, organizational, interpersonal, and written and verbal communication skills, with the ability to manage multiple priorities and collaborate effectively across functions
Proficiency with common business software, including Microsoft Word and Excel; familiarity with medical and/or clinical trial terminology is desirable
Ability to travel up to 10% and lift up to 25 lbs.; this role may require extended periods of computer work

Benefits

Comp & perks

Competitive compensation
Medical, dental, and vision coverage
Tuition reimbursement
Employee assistance and wellness programs
Life and disability insurance