Quality Associate Jobs

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter’s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives— where your purpose accelerates our mission.

RESUMEN GENERAL (SUMMARY):

Incumbent will be responsible for insuring compliance with the Quality System Regulation regarding Quality and Manufacturing Processes and methods. In order to perform effectively the incumbent must be knowledgeable of all processes, product specifications and quality functions. Provide support and service to their respective areas. Responsible to ensure their responsibility areas are in compliance with internal and external regulations. Capable of or following instructions effectively and in timely manner. Participate in protocols, first of codes, Non-compliances and exceptions evaluation, changes of specs. SOP’s, special tests and /or projects.

TAREAS Y RESPONSABILIDADES (DUTIES AND RESPONSABILITIES):

Participates in the revision of Process and Software Validations protocols of equipment, new product and / or database applications.

Participate and maintain full knowledge of the operations

Prepare on a Monthly basis the Quality Data Review and Management review presentations of the Operations area.

Responsible of the Day to Day Quality Operations activities of the operations area

Product Retention Records approval and closing

Create and modify procedures as needed.

Attend meetings where day to day activities are discussed such as Tier.

Support POMS System. Approval of exceptions and comments as Quality Representative

Take decision, problem solving, time management, negotiations, personnel interview, feedback and recognition.

Support in the implementation of Corrective and Preventive Actions.

Evaluation and approval Non-Conformance Records and Corrective and Preventive Actions

Evaluation and Approval of Change Control records

Be facilitator of long term Quality Improvement Programs.

Keep in compliance with GMP, FDA, ISO requirements, and other Regulatory Agencies.

Support the design, development, enhancement of new product, processes and technologies.

Active Participation in the Non Conformances investigation process.

Any special project as assigned.

Promote a zero-harm work place and assure that required EHS resources are available and that all applicable EHS practices and rules are being followed by supervised employees.

DEMANDA FISICA (PHYSICAL DEMANDS):

Light Work: Exerting up to 20 pounds of force occasionally and/or a 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects. Physical demands requirements are in excess of those for Sedentary Work. Even though the weight lifted may be only a negligible amount, a job should be rated Light Work: (1) when it requires walking or standing to a significant degree; or (2) when it requires sitting most of the time but entails pushing and/or pulling of arm or leg controls; and/or (3) when the job requires working at a production rate pace entailing the constant pushing and/or pulling of materials even though the weight of those materials is negligible.

EDUCACIÓN Y/O EXPERIENCIA (EDUCATION AND/OR EXPERIENCE):

Bachelors Degree in Science. Zero to One-year experience.

CUALIFICACIONES (QUALIFICATIONS):

Uses management practices/knowledge, statistical methods, computer systems and technical reporting. A self-starter capable of maintaining full understanding and up to the moment information of the Quality day-to-day activities. An individual with the ability of interacting with personnel from all levels, capable of supervising and or following instructions effectively and in timely manner. Must be willing to travel occasionally.

IDIOMA (LANGUAGE):

Fully bilingual (English & Spanish).

The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
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Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

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