Senior Quality Assurance Auditor

Job not on LinkedIn

🔥 12 hours ago

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

⏰ Full Time

🟠 Senior

🔧 QA Engineer (Quality Assurance)

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 10%

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Clario

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

Founded 1973

🏥 Healthcare

💼 Consulting

📦 Logistics

💰 Private Equity Round on 2019-10

Healthcare • Consulting • Logistics

Clario is a company specializing in accelerating clinical trials from initiation to implementation through advanced technologies and services. Since 2018, Clario has revolutionized endpoint analyses in clinical trials by integrating over 30 artificial intelligence-enabled solutions across more than 600 active trials, enhancing data quality and patient privacy while expediting data collection processes. Clario provides a comprehensive clinical trial management platform, offering solutions such as eCOA, cardiac safety, medical imaging, precision motion, and respiratory services in various therapeutic areas including oncology, cardiology, and neurology. Known for its global reach, Clario supports clinical trials in over 100 countries with a strong focus on decentralized and hybrid trial models. The company's commitment to patient safety and innovation is reflected in their over 26,000 trials and involvement in numerous new drug approvals.

📋 Description

• 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

• 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

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