Quality Associate I

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Overview

This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives.

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Success Profile

What makes a successful Quality team member at Baxter? Take a look at some of the top traits we’re looking for and see if you’re a fit.

Detail Oriented
Continuous Learner
Courageous
Collaborative
Critical Thinker
Influential

Quality Associate I

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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 PURPOSE:

Coordinate, perform and provides technical support in the submission of Field Alert Reports (FAR) and Field Corrective Actions (FCA) related to Jayuya products. Support Complaint investigations and follow up until implantation of corrective actions associated to FAR/FCA. Supports and follow up corporate holds associated with FAR/FCA. Supports and follow up in the samples requisitions and related protocols for products impacted by a FAR or a FCA. Assists and support the activities of audits, documentation functions for external and internal audits. Assures that the Baxter Jayuya facility complies with, all internal and external applicable standards for areas of responsibilities.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Coordinate, manage, review the information and follow up Field Alert Report (FAR) at the Facility.
Coordinate, manage, review the information and follow up Field Corrective Action (FCA) at the Facility.
Coordinate and follow up complaints investigations and samples evaluations related to FCA & FAR.
Coordinate/ generate and follow up corporate holds associated with FAR/FCA.
Coordinate/ Supports and follow up in the samples requisitions and related protocols for products impacted by a FAR or a FCA.
Handling and follow up commitments for FCA and FAR processes.
Prepared and document the Management Review and Quality Data Review with regards to FCA & FAR.
Provide the reports to the appropriate company groups on time.
Performs changes to procedures for areas of responsibilities.
Supports in the handling of information requests from other companies or countries with regards to product included in a FCA.
Coordinate, participate and perform communication, meetings or teleconference with company departments or facilities, as required.
Fill out, files and controls all related documentation for areas of responsibilities assuring the compliance with all standards and company retention requirements.
Support the FDA readiness plan.
Provide supports to the Quality Assessment Manager during the FDA inspections, ISO, suppliers, clients and other audits, when required.
Support and perform Internal Audits, as required.
Team worked oriented.
Able to work under minimum supervision and to handle multiple tasks at the same time.
Occasionally required to work extra hours, Holidays (e.g. shutdowns, FDA Audits, ISO 9001 Audits, Pharma Partner audits and Due Diligence audits).
Able to prepared and /or provide training, when required.
Support other department, as required.

QUALIFICATIONS

EDUCATION and/or EXPERIENCE

Bachelor's degree in Sciences (B. S.) or Business Administration (MBA - preferred); two to four year of previous experience in Quality and Manufacturing areas; computer knowledge (Word, Power Point, Excel, Trackwise). Qualify Auditor Certification – preferred. Excellent communication skills. LEAN Knowledge (prefer).

Knowledge in regulatory standards as ISO 9001: current version, FDA Regulations current version, and ICH.

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.

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Address

Explore this location PO Box 518 Road 144 Km 20.6
Jayuya, PR 00664
United States of America Explore This Location

Hear from Our Employees

Our company is enriched by a diverse population of individuals in more than 100 countries that work to solve, innovate, manufacture and drive better healthcare options for patients around the world.

Meet Christelle, Senior Quality Manager in Malta

“I was an Engineering Graduate with a Master's in Business Administration, and was more inclined toward working with people than with machines. When I came across an opportunity to work with Baxter as a Quality Engineer, it was the perfect combination: a manufacturing environment and a role that required me to collaborate with multiple teams daily. Baxter's mission of saving and sustaining lives gives me all the purpose and fulfilment I need.”

Meet Lorena, Senior QA Associate in London, UK

“I am registered pharmacist in the UK with experience with drug products and final product release. I am very dedicated to my work and accurate in details to ensure correct assessment is provided to our customers to ensure patients' safety.”

Meet Gary, Quality Research Manager in Singapore

“I have always enjoyed working at Baxter and I find here to be a great place to work! Management truly cares for you, and invests time and resources to support your career goals and aspirations. My current role provides me the opportunity to work with culturally diverse teams, bringing different talents together, learning from one another and working toward a common goal and mission.”

Join Our Talent Community

We're grateful for your interest in a career with Baxter, and would like to get to know you. Joining our Talent Community is a great way to stay connected, learn more about Baxter, and help our recruiters find you if there's an opportunity that aligns with your background, skills and interests.

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Quality Associate I

Overview

Success Profile

Quality Associate I

Address

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Hear from Our Employees

Meet Christelle, Senior Quality Manager in Malta

Meet Lorena, Senior QA Associate in London, UK

Meet Gary, Quality Research Manager in Singapore

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Join Our Talent Community