BD (Becton, Dickinson and Company) Jobs

Job Description Summary

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.

Position Summary:

The Sr. Quality Specialist is responsible for supporting Bard Operations Center (BOC) Quality & Compliance Program, ensuring regulatory compliance by handling activities pertaining to the Inspire Quality Initiative and additional activities as required, staying in sync with local, federal and any other applicable regulation and or international standard. The Sr. Quality Specialist will lead the Inspire Quality project and provide guidance or assistance to the BOC facilities.

This position is a fixed- term assignment which will not include benefits such as medical, health, dental, 401k, and is anticipated to last approximately through December 2023.

Essential Duties and Responsibilities

BOC Quality and Compliance:

• Leads Quality Systems projects (QS standardization, implementation of BD Global systems, etc.) for the BOC, including the MX facilities

• Responsible for the completion of gap assessments and the implementation of Local Implementation Documents for the BOC Guaynabo site

• Leads and updates the Guaynabo site Inspire Quality Initiative Quality Plan

• May participate in Inspire Quality Blitz meetings for certain elements as required

• Responsible for the Document of External Origin management activities for the BOC

• Develops and establish the necessary procedures to meet ISO standards, where necessary

• Ensures the timely implementation and record of changes needed to correct and prevent identified quality problems

• Develops and conducts training in all major changes to the quality management program, when required

• May act as administrator for electronic systems such as Master Control, Trackwise and others for the BOC site

• Supports general BOC Quality System Quality Management activities within the department

• Interacts with quality, compliance and or regulatory counterparts at other BOC sites and Business Units, to solve issues, answer general questions and or investigations.

• May perform internal audits to verify compliance with cGMP’s, and applicable ISO standards

• Supports/participates on Internal, External, Third Party and/or regulatory agency audit activities

• May prepare quarterly Management Review, Weekly or Monthly Reports, when necessary

• May conduct internal audits for the BOC MX sites

• May be responsible for BOC procedures maintenance and for the completion of gap assessments related to Corporate/Global documents (e.g., policies, procedures, standards), as applicable

• May assist on activities like record retention for the BOC

• Ensure is trained before performing any task

• Uses the required clothes, personal and security protective equipment according to the requirements of its operation

• Follows the cGMP’s, Quality Standards, and established policies and/or procedures

• Must follow and stay in sync with company policies and procedures, as applicable in the role

• Performs other duties assigned by supervisor

Education and Experience Required:

• Bachelor’s Degree in Science, Engineering. Other fields may be considered if candidate complies with years of experience

• Seven (7) or more years’ experience in the quality control field, in a pharmaceutical or medical device manufacturing facility, with at least five (5) years’ experience on Quality and Compliance Management

Skills & Knowledge:

• Must have strong verbal and written communication skills and must be able to successfully work with technical and non-technical personnel

• Must be fully bilingual (English/Spanish) and must have good communication skills both oral and written

• Certified Auditor, ASQ CQA, CQE, CQMOE or equivalent--preferred

• Strong analytical and problem-solving skills used to effectively judge the quality, timeliness and completeness of documents and gap assessments

• Team-work oriented

• Proficient on MS Office (Excel, Word, Power Point)

• Must be able to interact with different kinds of people in a harmonious manner, being cognizant of basic corporate, plant and department goals

• Green/Black Belt Certification--preferred

• Knowledge of MS Project

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.

You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time. And through the organization’s investment in BD University, you will continually level up your tech skills and expertise.

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 health. At BD, you’ll discover a culture in which you can learn, grow and thrive. And find satisfaction in doing your part to make the world a better place.

To learn more about BD visit https://bd.com/careers

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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, or any other protected status.

PDN

Primary Work Location

USA PR - Guaynabo

Additional Locations

Work Shift

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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, or any other protected status.