Job Description Summary

BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company develops innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its 65,000 employees have a passion and commitment to help improve patient outcomes, improve the safety and efficiency of clinicians’ care delivery process, enable laboratory scientists to better diagnose disease and advance researchers’ capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. BD helps customers enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. bd.com

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.

The Documentation Clerk 1 will support the Quality System Specialist - Documentation and Data Management in the implementation and maintenance of the organization’s Document Control and Engineering Change Order (ECO) systems. Works with users of controlled documentation to ensure internal customer satisfaction and conformance to regulatory standards. Assists in internal and external audits retrieving requested documentation, assist 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. Assists in the maintenance of the plant quality record filing. Receives instructions from the Quality Manager, Associate Quality Manager, Quality Supervisor and Quality System Specialists on routine work and on new assignments.

DUTIES AND RESPONSIBILITIES

• Assists the Quality Specialist in the execution of the Document Control and Engineering Change Order (ECO) systems activities in accordance with GMP and quality standards.

• Maintains and coordinates documentation as required by the manufacturing facility such as Device Master Records, Device History Records, Customer Complaint Records, Forms Control System, Calibration Records, and other documentation activities as required.

• Assist in maintaining, controlling, verifying, and ensure ECO's are processed using electronic system is accurate and in a timely manner.

• Performs quality record scanning and maintains electronic filing system per internal customer requirements.

• Maintains controls, verifies, and ensures SAP database implementation of Engineering Change Order (ECO) incorporation is accurate and completed in a timely manner.

• Maintains numbering systems for new and revised quality system documentation.

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

• Maintains an accurate Master Record filling system.

• Ensure that all batch records are completed, and filed.

• Assist in the review of documents for completeness and accuracy.

• Keeps abreast of the basic requirements for compliance 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.

• Interact with all teams at BDB Cayey, other BDB plants and BD affiliates.

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

• Perform other related duties and assignments, as requested by management (e.g. Metric Maintenance/Reporting).

MINIMUM QUALIFICATIONS

EDUCATION AND EXPERIENCE

• Requires at a minimum an Associate Degree or equivalent

• A minimum of one (1) year of experience in documentation control system in a FDA & ISO regulated environment.

KNOWLEDGE AND SKILLS

• Knowledge of current regulatory requirements for pharmaceutical/medical devices industry.

• Knowledge on Documentation Control Systems.

• Demonstrated ability to perform detail oriented 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.

• 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.

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.

Primary Work Location

USA PR Cayey - Vicks Drive (BDB)

BD is a Fortune 500 global medical technology company headquartered in Franklin Lakes, New Jersey, with offices in more than 50 countries. The company operates three business segments: BD Medical, BD Life Sciences and BD Interventional. 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 the design and engineering, to the manufacturing and the marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.