Sr Quality Assurance Auditor

Clario•Philadelphia, PA

About The Position

At Clario, a part of Thermo Fisher Scientific, the Senior Quality Assurance Auditor helps maintain regulatory compliance and strengthen the Quality Management System (QMS). The role leads and supports internal, external, vendor, customer, and regulatory audits, partnering with cross-functional teams to identify compliance risks, resolve quality events, and drive continuous improvement. It also provides quality guidance and mentorship across the organization.

Requirements

Associate’s degree or equivalent, 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.
At least 5 years of relevant experience in Quality Assurance, auditing, validation, and/or software development lifecycle (SDLC) systems within a regulated industry.
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, written, and verbal communication skills, with the ability to manage multiple priorities and collaborate across functions.
Proficiency with common business software, including Microsoft Word and Excel.
Ability to travel up to 10%, lift up to 25 lbs., and work at a computer for extended periods.

Nice To Haves

Experience in pharmaceutical, contract research organization (CRO), biotechnology, or medical device industries.
Familiarity with medical and/or clinical trial terminology.

Responsibilities

Plan, conduct, lead, and report internal, external, vendor/supplier, customer, registrar, and regulatory audits in accordance with applicable SOPs and electronic document management system processes.
Manage and monitor audit findings, quality events, 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, particularly for the audit program and QMS.
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.