Study Director I

Responsibilities

• Take 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 accurately and on time.
• Ensure final reports are compliant with current procedures and accurately reflect data, results, and conclusions.
• Maintain sample and data traceability throughout the testing process.
• Ensure compliance with regulatory requirements including GMP, GLP, and ISO.
• Collaborate with the Sales department on testing quotes and communicate regularly with sponsors regarding study updates.
• Coordinate workflow and manage project timelines to meet sponsor expectations.

Requirements

• B.S. degree in life sciences (strongly preferred), OR
• A.A./A.S. degree with two years of laboratory experience, OR
• High School diploma/GED with five years of laboratory experience.
• Knowledge of GMP, GLP, and ISO standards.
• Proficiency in Good Documentation Practice (GDP).
• Strong proficiency in Microsoft Office and laboratory information systems.
• Ability to work in a professional laboratory environment, including wearing 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 testing to ensure the safety of millions of patients and healthcare practitioners worldwide.