Quality Assurance Auditor I

Job not on LinkedIn

🔥 0 minutes ago

🇷🇴 Romania – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🔧 QA Engineer (Quality Assurance)

👻 Ghost score 10%

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Everest Clinical Research

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2004

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Everest Clinical Research is a global contract research organization (CRO) that provides end-to-end clinical trial services and biometrics expertise to pharmaceutical and biotechnology sponsors. The company offers clinical operations and project management, risk-based quality management and centralized monitoring, medical monitoring, pharmacovigilance, clinical data management, biostatistics and statistical programming, regulatory strategy and submissions, and technology solutions such as IRT/RTSM and ePRO/eCOA. Everest positions itself as a high-touch, quality-driven partner with global reach and therapeutic expertise across oncology, neurology, respiratory, rare diseases and immunology.

📋 Description

• Complete scheduled internal audits to assess compliance with applicable regulatory requirements and Everest Standard Operating Procedures (SOPs) • Document and report audit findings in a timely manner • Follow up on compliance issues until resolution • Maintain governing documents according to SOPs, including entering tracking information into a database and updating records • Report and follow up on outstanding SOP review obligations • Assist with external client audits and regulatory inspections • Assist with employee training on QA procedures • Assist with investigations of non-conformities • Research and participate in relevant training or association activities concerning industry best practices in QC and QA

🎯 Requirements

• Bachelor’s degree in health science, physics, biology, or mathematics • Certificate in QA and auditing concepts (preferred) • At least 3 years’ experience in a clinical research capacity • At least 1 year of auditing experience • Knowledge of clinical trial processes and procedures • Knowledge of pharmaceutical industry regulatory requirements, including FDA, Health Canada, and European Medicines Agency requirements • Comprehensive knowledge of ICH and GCP guidelines • Knowledge of QC and QA processes and procedures • Knowledge of procedural document management, auditing, and training concepts • Excellent analytical and creative problem-solving skills • Solid conflict resolution skills • Commitment to quality and process improvement • Ability to provide timely quality deliverables • Effective oral and written communication skills with personnel at all professional and administrative levels • Detail-oriented with exceptional ability to notice inconsistencies • Well organized with strong multi-tasking skills • Ability to concentrate on assigned tasks over extended periods • Comprehensive skills in Microsoft Office applications

🏖️ Benefits

• Remote work arrangement • Equal opportunity employer • Accommodations for candidates with disabilities during recruitment and selection upon request