Job Description

At Bristol Myers Squibb, we are inspired by a single vision transforming patients lives through science. In oncology, hematology, immunology and cardiovascular disease and one of the most diverse and promising pipelines in the industry each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

The Records Management Specialist will manage the document change control process, coordinating cross functional reviews, approvals and effective targets in alignment with requirements (cGMP and BMS) and customer needs.

Responsibilities

* Executes the initiation, processing, routing, distribution and archiving of cGMP documentation and facilitates the compliance of site documentation
* Serves as a subject matter expert for the electronic document management system and electronic learning management system and provides system metrics as needed
* Provides backroom support during in regulatory agency inspections and corporate audits including the provision of system reports
* Manages and executes the initiation, processing, routing, distribution and archiving of training documentation and associated curricula updates
* Performs training assessments for new/ revised documents and associated performance qualifications in alignment with requirements (cGMP and BMS) and customer needs
* Conducts user training on the document management system and electronic learning management system, as needed

Qualifications

* A minimum of 4 or more years of relevant experience including a minimum of 2 years of document management or administrative / project coordination experience in a regulated environment focused on product quality is required
* Strong customer service skills (collaboration and communication) and the ability to follow written and verbal instructions are required
* Excellent computer skills and proficiency with MS Office is required
* Ability to perform well in a team-based environment is required
* Familiarity with applicable US and EU cGMP regulations and guidance is preferred
* General knowledge of biologics manufacturing and testing concepts is highly desirable

BMSBL

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.