Job Description Summary

The position is responsible for the revising, formatting, and editing of division documents as requested by document owners.

Job Description

We are the makers of possible

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities.

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us.

• Participates in regulatory compliance audits and inspections.
• Participates in investigations.
• Completes applicable job-specific training.
• Effectively manage the end-to-end change lifecycle and identify process improvements where possible.
• Day to day management of change requests.
• Reporting of change to both internal and customer management teams.
• The position will identify and drive continuous improvements to the quality and efficiency of the change management process.
• Applies skills and develops documentation including operating procedures, process flow charts and manufacturing procedures.
• Documentation origination, editing and revision.
• Creation of change request and associated paperwork utilizing the Electronic Document.
• Management System (EDMS).
• Uses various computer software applications to complete assigned work activities.
• Understanding of compliance requirements and regulations.
• Ability to generate report(s) utilizing the systems.
• Work with teams to determine status of projects/document changes and assist with driving project/document changes to completion.
• Be able to develop and speak to metrics and workload tracking.
• Be actively engaged in meetings.
• Participates in the development of solutions to Quality System problems and/or noncompliance.
• Assists in maintenance of department, site / business unit, and corporate procedures and policies.
• Demonstrates knowledge of operating procedures and expertise in a specific functional area.
• Accountable for the execution of specific tasks with moderate discretion and with oversight from a supervisor.
• Carries out tasks and activities.
• Applies specialized knowledge/skills to perform routine and non-routine work of a group or department.
• Other duties, as assigned.

• Origination, editing and revision of product documentation.
• Creation of change request and associated paperwork utilizing the Electronic Document Management System (EDMS).
• Assists Project Managers in monitoring the progress of assigned project and makes adjustments as necessary to ensure the successful completion of the project.
• Complete ownership of team documentation for New Product Development (NPD), or product transfers, including creation and launch of change requests (CR).
• Applies skills and develops documentation including operating procedures, process flow charts and manufacturing procedures.
• Other duties, as assigned.

• Basic understanding of regulations.
• Advanced language proficiency in reading, writing, understanding, and communicating in English.
• Attention to detail.
• Intermediate computer skills and software applications, including experience with Microsoft Office tools (Outlook, Word, Excel, PowerPoint).
• Intermediate organizational and administrative skills.
• Experience in working in a cross-functional team environment as well as the ability to function independently.
• Ability to gather and organize information.
• Ability to grasp technical terms, processes, and methods.
• Ability to handle a variety of projects at the same time.
• Ability to prioritize and organize a busy and changing workload.
• Ability to work in a team environment and/or independently with little supervision.
• Works collaboratively with a variety of people at all levels within the organization to ensure effective communication and success of key initiatives.
• Resolve problems by clarifying issues; researching and exploring answers and alternative solutions; implements solutions; escalates unresolved problems.
• Ability to be flexible in work schedule, including a willingness to work overtime as needed.
• Positive and Professional attitude.
• Previous experience in the medical device industry is preferred.
• Ability to read documents in rough draft format and type/format documents consistent with corporate guidelines.

• Intermediate knowledge of EDMS such as MasterControl, Team Center, Microsoft Word, Excel, and Access.
• 2+ years experience in a document control related position, preferably in an FDA and/or regulated environment.
• High school diploma or GED required.
• Associate's degree in related field preferred.