Summary: We are seeking a talented Validation Engineer to join our team. As a Validation Engineer, you will play a crucial role in ensuring the quality and compliance of our manufacturing processes and systems. You will be responsible for...
Job Description Summary: The CSV Specialist is responsible for planning, coordinating, and executing validation activities for computer systems to ensure compliance with regulatory requirements. This role involves working closely with IT,...
Responsibilities: This position is responsible for the preparation of regulatory submissions required to market medical devices in both the U.S. and Europe, support of international product registrations and related regulatory affairs act...
Responsibilities: Provide leadership, strategic planning, direction and implementation of clinical systems for data collection which may include vendor selection, budgeting, resource planning, vendor oversight, EDC build and study timelin...
Summary: The CQV Documentation Specialist is responsible for creating, reviewing, and maintaining high-quality documentation that supports commissioning, qualification, and validation (CQV) activities for manufacturing process equipment i...
Job Description: The Epi Forecasting Senior Epidemiologist will serve as a key contributor within the Epidemiology Forecasting Center of Excellence (CoE). In this contractor role, you will design and execute descriptive epidemiologic and p...
Responsibilities: Develop, implement, and maintain Quality Management Systems (QMS) in compliance with FDA, EMA, ICH guidelines, and other regulatory requirements. Ensure all processes and products comply with applicable regulatory stand...
Job description: Summary: Independently execute and review routine in-process, drug substance, and stability test methods in a timely manner. Use a variety of laboratory instrumentation and computer systems to collect and record data (s...
Summary : We are seeking a highly skilled and detail-oriented Supplier Quality Engineer to join our team. The ideal candidate will have a strong background in medical device supplier quality, with hands-on experience in supplier qualifica...
Summary: Testing Method(s) experience. Good communication skills. Experience with a variety of laboratory instrumentation and computer systems to collect and record data (such as LIMS, Charles River Endoscan, MODA). A Good understandin...