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Quality Document Control Specialist

In-Office, Tempe, AZ

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Job ID
R-544205
Category
Quality
Location
Tempe, Arizona

We are the people who give possibilities purpose

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 Description

Responsibilities:

  • Day-to-day management of change requests:

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

    • Reviewing change request documentation.

    • Document creation and editing.

    • Effectively managing the end-to-end lifecycle of change requests.

    • Reporting of status of in-process change requests to supervisor and project management teams, including speaking to metrics and workload tracking.

    • Using various computer software applications to complete assigned work activities.

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

  • Operating with a compliance mindset toward regulations and standards.

  • Participating in meetings.

  • Identifying and suggesting continuous improvements to the quality and efficacy of the change management process.

  • Assisting with the execution of team projects and ancillary processes.

  • Other duties and projects, as assigned. Including, but not limited to:

    • Participating in investigations.

    • Participating in regulatory compliance audits and inspections.

Education and Experience:

  • High School Diploma or GED required; associate or bachelor's Degree strongly preferred

  • At minimum 1 year experience in a documentation related position, preferably in an FDA and/or regulated environment.

  • 1 – 3 years relevant experience

Required Qualifications:

  • 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 including the ability to prioritize, organize and process a busy and changing workload.

  • Ability to handle a variety of tasks concurrently.

  • Ability to work in both a cross-functional team environment and independently with little supervision.

  • Ability to be flexible in work schedule, including a willingness to work overtime as needed.

  • Positive and Professional attitude.

Preferred Qualifications:

  • Basic understanding of regulations and standards.

  • Basic working knowledge of quality management system documentation and records.

  • Prior quality systems, manufacturing, laboratory, or product development experience.

  • Experience in electronic document management systems, e.g., MasterControl, Teamcenter, PEGA, etc.

Why Join Us?

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

To learn more about BD visithttps://bd.com/careers.

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.

Required Skills

Optional Skills

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Primary Work Location

USA AZ - Tempe Headquarters

Additional Locations

Work Shift

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