Job Description Summary

Support the manufacturing areas in the implementation of document changes through the Engineering Change Order (ECO) systems. Assists in writing and reviewing departmental procedures and is also responsible for the expeditious processing of new SOP's, tracking and initiating Engineering Change Orders and securing completed documentation for all manufacturing areas. Assists in manufacturing data collection and metrics. Supports CI Initiatives as requested.

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. 

 DUTIES AND RESPONSIBILITIES

• Support the manufacturing areas in the implementation of document changes through the Engineering Change Order (ECO) systems.

• Ensure documentation changes related to Capital/Validation projects, Quality Notifications or CAPAs are implemented in a timely manner not to impact project timeline or due dates.

• Active participation in CI/Lean Activities.

• Assists in manufacturing data collection and metrics.

• Responsible for the creation of SOPs, manufacturing batch records and other GMP required documentation for the manufacturing areas by formatting and word processing, as needed.

• Stays updated with the fundamental requirements in own area of work and aligns with those requirements. Participates as required in training on regulatory issues affecting their working area. Brings regulatory compliance questions/issues to the attention of management.

• Promotes a safe work environment. May provide recommendations on maintaining the safety of the work environment. Participates in Environmental Health and Safety programs. Addresses corrective actions whenever a hazard is identified. Notifies supervisor of all observed hazardous conditions or unsafe work practices.

• Provide recommendations to support systems that continuously improve product/process quality and product availability, reduce cost, and increase production capability.

• Other duties as assigned, such as, but not limited to management of deviation records and periodic review of documents.

• Perform other related duties and assignments, as requested by management.

 MINIMUM QUALIFICATIONS

KNOWLEDGE AND SKILLS

• Knowledge on Documentation Control Systems.

• Demonstrated ability to perform meticulous work with a high degree of accuracy.

• Demonstrated ability to follow established policies and procedures.

• Effective skills on interpersonal relationships, written and oral communication, planning/organization, time management, and proactive participation.

• Proficiency in the use of Personal Computer, scanner and office related equipment.

• Proficiency on MS Office (Word, Excel and PowerPoint).

• Knowledge of current business systems and application software (MS Office or equivalent)

• Must be capable of independent work; a self-starter, highly motivated and able to work with minimal supervision.

• Fully bilingual (English and Spanish).

• Attendance and punctuality are an essential function of the job position.

EDUCATION AND EXPERIENCE

• Requires at a minimum an Associate Degree or equivalent with a minimum of two (2) year of experience in documentation control system in a FDA & ISO regulated environment.

SUPERVISION

N/A

MENTAL DEMAND

• Apply commonsense understanding to carry out detailed written or oral instructions.  Manage stressful situations.

PHYSICAL DEMAND

The work requires lifting, carrying, pushing and pulling of light weight level objects.  In addition, occasionally requires standing, walking, reaching, seeing (far vision and depth perception).  Frequently, the job requires sitting, handling, fingering, talking, hearing, seeing (visual color discrimination) and constantly requires seeing (near vision).

WORKING ENVIRONMENT

The work is performed constantly inside the building.  Does not present risks and discomforts in the employee's physical surroundings.

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

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.  

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. 

#earlycareer

Required Skills

Optional Skills

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Primary Work Location

USA PR Cayey - Vicks Drive (BDB)

Additional Locations

Work Shift

US BD 1st Shift 8am-530pm (United States of America)