Job Description: The Bioresearch Center is seeking a dedicated and talented full-time contractor for the position of Biologist I or II to join the Immunology Discovery Dermatology team in Worcester, MA. The role involves the design and exe...
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...
Summary: The Lead Validation Engineer will oversee and drive commissioning and qualification (C&Q) activities for automation and process systems at a regulated manufacturing site. This leadership role is responsible for ensuring validati...
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: 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: 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...
Summary : Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of new product development products to meet or exceed internal and external requirements. Roles & Re...
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...
Responsibilities: Designs, engineers, and implements quality systems to ensure regulatory compliance and quality improvements. This includes designing, planning, and executing validation activities for Over the Counter (O.T.C.) Drugs in ...
Responsibilities: Review protocols and comply with study-specific activities that impact telemetry areas of responsibility. Communicates in an appropriate and professional manner with study subjects and unit personnel. Maintain accurate...