Sr Quality Assurance Auditor

Clario; Philadelphia (Philadelphia County); On-site; USD 70,000 - 110,000; Full time

Benefits offered by this job

Medical, dental, and vision coverage

Tuition reimbursement

Employee assistance and wellness

Life and disability insurance

Competitive compensation

Job summary

Clario, part of Thermo Fisher Scientific, seeks a Senior Quality Assurance Auditor to lead audits across internal, external, vendor, and regulatory domains. You will mentor teams, identify compliance risks, and drive improvements within the Quality Management System.

You will apply GCP/ICH knowledge and QA expertise to ensure accuracy of documents, CAPAs, and quality metrics, while collaborating with cross-functional groups to uphold regulatory standards.

Qualifications

• Associate's degree or equivalent required.
• Quality or quality systems certification (e.g., ASQ Auditor) or equivalent experience.
• 5+ years of relevant experience in Quality Assurance, auditing, validation, and/or SDLC within regulated industry.

Responsibilities

• Plan, conduct, lead, and report internal, external, vendor/supplier, customer, registrar, and regulatory audits.
• Manage and monitor audit findings, CAPAs, root cause activities, and effectiveness checks.
• Track and trend audit activities, compliance reports, CAPAs, and quality metrics; communicate risks to management.
• Perform QA reviews of source documents, CRFs, reports, and validation deliverables for accuracy and compliance.
• Partner with cross-functional teams to identify risks and implement process improvements for the audit program and QMS.
• Provide quality-related guidance and training to colleagues and mentor personnel.
• Develop or revise SOPs and maintain current regulatory standards.

Skills

GCP & ICH Guidelines

Leadership & mentoring

Strong communication

Education

Associate's degree or equivalent

Tools

Microsoft Word

Excel

QMS software

Job description

At Clario, a part of Thermo Fisher Scientific, the Senior Quality Assurance Auditor plays a key role in maintaining regulatory compliance and strengthening our Quality Management System (QMS). You will lead and support internal, external, vendor, customer, and regulatory audits while partnering with cross-functional teams to identify compliance risks, resolve quality events, and drive continuous improvement. This is an opportunity to apply your quality expertise while providing guidance and mentorship across the organization.

What We Offer

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

What You'll Be Doing

• 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.

What We Look For

• 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.

At Clario, a part of Thermo Fisher Scientific, a part of Thermo Fisher Scientific, our purpose is to transform lives by unlocking better evidence. It's a cause that unites and inspires us. It's why we come to work-and how we empower our people to make a positive impact every day. Whether you're advancing clinical science, building innovative technology, or supporting our global teams, your work helps bring life-changing therapies to patients faster.

Clario, a part of Thermo Fisher Scientific is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.