Quality Document Systems Management Specialist I

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.

Job Responsibilities:

• Serves as a subject matter expert (SME) for document control and change management processes, providing guidance, feedback, training, and support to internal and external stakeholders.

• Leads and executes assigned team projects and related processes with minimal supervisory oversight.

• Assists in the development, maintenance, and improvement of department procedures, policies, and operational processes.

• Participates in troubleshooting, root cause analysis, and the development of solutions related to Quality System issues, nonconformances, and process improvement opportunities.

• Provides objective feedback and recommendations to drive continuous improvement in the quality, efficiency, and effectiveness of the change management process.

• Facilitates, participates in, and contributes to meetings related to document control, change management, and departmental initiatives.

• Develops, tracks, analyzes, and presents workload and performance metrics.

• Maintains a compliance-focused mindset and ensures activities align with applicable regulations, standards, and quality system requirements.

• Performs all activities associated with change request (CR) processing, including:

• Day-to-day management of change requests.

• Creation of change requests and associated documentation within the Electronic Document Management System (EDMS).

• Review of change request documentation for accuracy, completeness, and compliance.

• Creation, revision, and maintenance of controlled documents.

• Management of the end-to-end change request lifecycle.

• Reporting the status of in-process change requests to supervisors, project teams, and management.

• Utilizing approved software applications and systems to complete assigned activities.

• Collaborating with project teams, document owners, and stakeholders to drive project and document changes to completion.

• Participates in regulatory audits, inspections, investigations, and other quality system activities as required.

• Performs other duties as assigned.

Education and Experience:

• Associate’s degree / bachelor’s degree in a related area or comparable years of experience.
• At minimum, 1 year of experience in a documentation-related position, preferably in an FDA and/or GMP-regulated environment.
• 2 – 4 years relevant experience.

Knowledge and Skills:

• Ability to perform the duties of a JD-B2-14242 - Quality Document Sys Mgmt. Change Coordinator II.
• Advanced language proficiency in reading, writing, understanding, and communicating in English.
• Attention to detail.
• Intermediate to advanced computer skills and software applications, including experience with Microsoft Office tools (Outlook, Word, Excel, PowerPoint).
• Intermediate to advanced organizational and administrative skills including the ability to prioritize, organize, and process a busy and changing workload.
• Intermediate working knowledge of quality management system documentation and records (work instructions, technical documentation, etc.).
• Intermediate understanding of regulations and standards.
• Ability to collect, organize, and analyze data and identify trends to offer solutions.
• Experience in electronic document management systems, e.g. MasterControl, PEGA, etc.
• Ability to work in both a cross-functional team environment and independently with little supervision.
• Ability to work collaboratively with a variety of people at all levels within the organization to ensure effective communication and success of key initiatives.
• Ability to 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.
• Ability to grasp technical terms, processes, and methods.
• Ability to handle a variety of tasks concurrently.

• Intermediate knowledge in MasterControl or PEGA.
• Prior quality, manufacturing, laboratory, or product development experience.