Study Director I

Responsibilities

• Hold overall responsibility for the technical conduct, review, interpretation, and reporting of assigned laboratory tests
• Act as the single point of study control to ensure all assigned studies are completed on time
• Ensure final reports accurately reflect data, results, and conclusions while maintaining compliance with current procedures
• Maintain sample and data traceability throughout the testing process
• Ensure calculations, statistics, and raw data are accurate and comply with Good Documentation Practices (GDP)
• Follow applicable regulatory requirements including GMP, GLP, and ISO
• Communicate regularly with sponsors to provide study updates and meet expectations
• Coordinate workflow and collaborate with the Sales department on testing quotes

Requirements

• B.S. degree in life science preferred
• Alternatively, an A.A./A.S. degree with 2 years of laboratory experience, or a High School diploma with 5 years of laboratory experience
• Knowledge of GMP, GLP, and ISO regulatory standards
• Proficiency in Good Documentation Practice (GDP)
• Strong proficiency in Microsoft Office and laboratory information systems
• Ability to work in a professional laboratory environment and wear required personal protective equipment (PPE)
• Ability to lift up to 45lbs and perform physical tasks such as bending, stooping, and crouching

About the Company

Nelson Labs, part of Sotera Health, is a global leader in outsourced microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries. Driven by the mission of Safeguarding Global Health®, we provide mission-critical services to ensure the safety of millions of patients and healthcare practitioners worldwide.