Study Director I or II

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 all data is accurately and concurrently recorded in accordance with regulatory requirements.
• Collaborate with the Quality department on the Quality Event (QE) process and Standard Test Procedures (STP).
• Communicate regularly with sponsors to provide study updates and meet or exceed expectations.
• Coordinate workflow and manage project timelines to ensure sponsor requirements are met.

Requirements

• B.S. degree in life sciences (strongly preferred), OR
• A.A./A.S. degree with 2 years of laboratory experience, OR
• High School diploma/GED with 5 years of laboratory experience and demonstrated proficiency in test coordination.
• Knowledge of GMP, GLP, and ISO regulatory standards.
• Proficiency in Good Documentation Practice (GDP).
• Strong computer skills, including 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, a 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 and sterilization solutions to ensure the safety of patients and healthcare practitioners worldwide.