Roles & Responsibilities : Develop and execute validation strategies Lead Process Validation & PPQ activities Perform C&Q for equipment, utilities, and facility systems Run risk and gap assessments Maintain equipment master data and s...
Job Summary: We are seeking an experienced and highly skilled Lead Validation Engineer to support validation, quality, engineering, and manufacturing programs within a cGMP-regulated biopharmaceutical environment. The ideal candidate bri...
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...
Job Description: Material Handler II is responsible for the safe, accurate loading and unloading of product within the distribution center. The following duties and responsibilities are intended to be representative of the work performed b...
Job Description: 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 acti...
Roles & Responsibilities: Develop quality assurance documentation for new product development and regulatory submissions. Maintain and improve quality system processes by identifying and correcting deficiencies. Engage in design, develo...
Job Description: The Manager, Quality Systems is responsible for providing end-to-end quality assurance oversight across designated manufacturing operations, which may include pharmaceutical products, medical devices, cosmetics, biologics...
Job Description: The Manager, Quality Systems is responsible for providing end-to-end quality assurance oversight across designated manufacturing operations, which may include pharmaceutical products, medical devices, cosmetics, biologics...
Job Description: We are seeking an experienced Method Validation Engineer to support the development, validation, and implementation of analytical methods—primarily dissolution and particulate matter testing (USP 788 )—for a GMP release ...
Job Description: The Manufacturing Associate is responsible for producing therapeutic proteins (Active Pharmaceutical Ingredient - API) under cGMP conditions. This role involves executing process recipes, following Standard Operating Proce...