Specialist Document – Bristol Myers Squibb Internship Logan

Position Title: Specialist Document

Company: Bristol-Myers Squibb

Location: Logan, UT, US

Job Description;

Bristol Myers Squibb has been active in the Dutch market for over 50 years, employing people across a range of activities and business units in Utrecht, The Netherlands. The Netherlands is also home to our first European Cell Therapy facility, located at the Leiden Bio Science Park, the largest life sciences cluster of The Netherlands. This new state of the art facility is focused on commercial manufacturing with capabilities for multi-product Cell Therapy manufacturing. You can become part of this exciting journey. Check out this video if you want to know more about it! The Netherlands has everything it takes to become the medicines hub of Europe, the so-called Boston by the North Sea. As we continue to expand our footprint by building this new site, we are looking to grow our team.

Responsibilities:

• Executes the initiation, processing, routing, distribution and archiving of cGMP documentation and directs the compliance of Leiden CTF documentation.
• Provides direction on the document change control business process for Leiden CTF to stakeholders and customers.
• Ensures alignment of department procedures with global and site policies and procedures.
• Serves as a subject matter expert for the electronic document management system to internal and external clients.
• Conducts user training on the electronic document management system.
• Provides direct Records Management support during regulatory agency inspections and corporate audits.

Requirements:

• Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry or related discipline, or its equivalent is preferred
• A minimum of 2 years of relevant experience, direct document management experience in a regulated environment focused on product quality is preferred.
• Strong teamwork and communication skills and the ability to follow written and verbal instructions are required.
• Knowledge of cell therapy, biologics manufacturing or analytical testing is highly desirable.