Quality Associate-II, QA Assurance (Monday to Friday 10:00h-18:30h)

This is where  your work makes a difference.

At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Here, you will find more than just a job—you will find purpose and pride. 

Your Team at Baxter

Within Quality, every role matters. Baxter’s products are shipped worldwide to patients in need. Whether you build new processes or solve unique production challenges, you have the trust and chance to bring creativity. No matter your role, your work will impact part of our global operation.

The mission of Baxter is to save and sustain lives. This mission is embedded into everything we do. This means if there is a decision to be made where quantity and quality are at odds, we will always choose quality. Our patients come first, always.

The Quality function values both working together as a team and independently. We draw energy from working in a plant or an office where there are opportunities to collaborate. As the company evolves, so does the way our team approaches work as it strives to build top-of-the-line products.

We build relationships with each other to get work done. Building these relationships is easy because we all share common traits of being reliable, ethical, and caring. We lean on our colleagues for their expertise and hold each other accountable. We feel empowered to speak up when there's a new insight or opportunity to improve something. This open dialog builds trust within the team and helps develop a better product for our customers.

What you'll be doing

Shift time: Monday to Friday 10:00h-18:30h EST

• Provide front line day-to-day assistance on product quality issues to ensure GMP, regulatory and procedural compliance to maintain high standards of quality.

• Support during assigned Shift, with the requirement to support plant overtime and planned shutdowns when applicable.

• Provide technical assistance on review and approval of department-related procedural changes, product quality concerns, reinspections, new product introductions, and protocols.

• Support timely follow-up on quality exceptions and their preventative/corrective actions.

• Support initiation/investigation and approvals of non-conformance events in the Trackwise system.

• Act as SME for Electronic Batch Record (EBR) and SPC or equivalent experience.

• Perform change control assessments/executions and approvals.

• Ensure control of defective WIP materials (quarantine, retention, and disposal areas) to keep segregation, movement, documentation, and timely follow-up within the plant in sync with regulatory and compliance requirements.

What you'll bring

Required:

• University Degree or equivalent experience, Bachelor of Science or equivalent experience.

• 3-5 years’ experience in manufacturing and quality roles.

• Prior experience working in a GMP setting.

• Knowledge of cGMP, ISO, and regulatory standards.

• Diligent with the ability to work effectively under pressure.

• Strong written and verbal communication abilities, negotiation capabilities, and the capacity to collaborate with individuals at every level of the organization.

• Ability to build positive relationships and partner with internal and external collaborators.

• Strong ability to balance multiple priorities.

• Strong analytical and problem-solving skills with critical thinking abilities.

• Intermediate to Advanced proficiency in MS Office Suite.

Preferred:

• 5+ years with exposure to various areas of the manufacturing environment.

• Experience in pharmaceutical, healthcare, or food manufacturing environments.

• Experience with continuous improvement methodologies, Lean 6S, Kaizen, TPM, DMAIC.

Join us in our mission to make a global impact with your outstanding skills and dedication to quality!

We understand that compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated salary range for this position is $86,400 - $129,600 annually, which reflects base salary as well as estimated target payout under the Management Incentive Compensation Plan. Individual pay will be determined based upon skills, expertise and experience, and the incentive, which is contingent upon company and individual performance outcomes. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.

This posting is for a current existing vacancy within our organization. We are actively seeking qualified candidates to fill this open position. If you are interviewed for this position, we will advise you within 45 days of the interview 
as to whether or not you were successful in obtaining the position. Information submitted as part of the job application process will be kept on file for 3 years from the date of submission in accordance with legislative 
requirements.

As part of our recruitment process, Baxter Corporation may use AI tools to assist screening candidates and assist in evaluating candidate qualifications. All final hiring decisions are made by the hiring manager and recruitment team

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.

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 .