Senior Specialist, Quality Assurance

🔥 12 hours ago

🌐 Turkey, France, +3 more countries – Remote

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⏰ Full Time

🟠 Senior

🔧 QA Engineer (Quality Assurance)

👻 Ghost score 10%

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Logo of MSD

MSD

10,000+ employees

Founded 1891

🏥 Healthcare

📦 Logistics

🧬 Biotechnology

Healthcare • Logistics • Biotechnology

MSD is a leading biopharmaceutical company known as Merck & Co. , Inc. in the United States, Canada, and Puerto Rico, and as MSD globally. The company focuses on scientific innovation to deliver medicines and vaccines for various health challenges, including oncology, vaccines, infectious diseases, and cardio-metabolic diseases. MSD operates multiple divisions, including Human Health, Animal Health, and Research & Development. With approximately 75,000 employees worldwide and a significant investment in research and development, MSD is committed to improving global health through its scientific advancements. Additionally, the company places a strong emphasis on diversity, inclusion, and corporate responsibility. MSD’s operations extend worldwide, offering opportunities in numerous regions and promoting diversity and innovation in all aspects of its business.

📋 Description

• Prepare and conduct QA audits • Generate audit reports and communicate results to QA management and relevant external stakeholders • Interact with teams to ensure corrective and preventative actions close QA observations • Analyze and leverage critical-to-quality factors to identify potential risks and prepare risk-based audits • Apply analytics dashboards and quality metrics to detect trends, prioritize audit focus areas, improve risk-based decision-making, and provide quality insights • Influence, partner, and collaborate with colleagues within and outside the team • Conduct GCP audits of investigator sites, studies, suppliers, third-party collaborations, and due diligence activities • Support identification of audit substrate for scheduling in alignment with risk assessments • Escalate quality issues, potential misconduct, and significant deviations to the QAL and TA Head • Provide day-to-day support to the applicable QA functional line for quality oversight of assigned studies • Support, advance, and drive Clinical Quality capacity planning and assignment of GCP audits

🎯 Requirements

• BS/BA degree or equivalent and/or experience in a relevant field • Proficiency in the primary activities and essential skills required for the role • Experience or proficiency in audits compliance • Data analysis skills • Detail-oriented approach • Deviation management • Leading by influence • Process improvement skills • Quality assurance systems knowledge • Quality risk management • Technical writing • Ability to travel 50%–70% • Ability to support, advance, and drive Clinical Quality capacity planning and assignment of GCP audits

🏖️ Benefits

• Remote work arrangement • Regular employee status • Travel opportunity (50%–70%)

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