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. 

Job Description

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).

DECLARACION DE NEGACION (DISCLAIMER STATEMENT)

Las declaraciones mencionadas anteriormente describen la naturaleza general y el nivel de                                                 

trabajo que se les requiere a los empleados a quienes se les asigna esta clasificación. No pretende constituir una lista exhaustiva de las responsabilidades, tareas y destrezas requeridas para el personal así clasificado.

The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed, as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.

US Benefits at Baxter (except for Puerto Rico)

This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees. For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter

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.

Know Your Rights: Workplace Discrimination is Illegal

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.

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.