Quality Specialist

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.

Quality Specialist – Baxter Compounding Quality Specialist At Baxter, every quality decision has the potential to impact a patient's care. As a Quality Specialist supporting our Compounding business, you will play a critical role in ensuring the quality, safety, and compliance of products that healthcare providers rely on every day.

Based on-site, you will partner with manufacturing, technical, and operational teams to strengthen quality systems, support regulatory compliance, and drive continuous improvement. This is an opportunity for a quality professional who wants to influence outcomes, solve meaningful challenges, and contribute to work that helps save and sustain lives.

Your Role at Baxter As a Quality Specialist, you will help safeguard the integrity of our products, processes, and quality systems across the Baxter Compounding operation. You will serve as a trusted quality partner, supporting investigations, continuous improvement initiatives, regulatory compliance activities, and quality system performance.

Working closely with cross-functional teams, you will help ensure products consistently meet the highest standards of quality, safety, and compliance while supporting operational excellence and inspection readiness. What You'll Be Doing Partner with manufacturing, technical, and support teams to provide quality guidance, resolve quality-related issues, and promote a culture of compliance and continuous improvement.

Lead and support investigations into deviations, non-conformances, customer complaints, and quality events, ensuring robust root cause analysis and effective corrective and preventive actions (CAPAs). Manage key quality system processes, including change controls, risk assessments, documentation reviews, and quality records to maintain compliance with regulatory and company requirements.

Review and approve quality documentation, validation deliverables, procedures, protocols, and reports to support operational effectiveness and regulatory readiness. Monitor and analyze quality metrics, trends, environmental monitoring results, and performance indicators to identify opportunities for improvement and proactive risk mitigation.

Support product lifecycle quality activities, including annual product quality reviews, stability programs, new product introductions, and project implementation initiatives. Contribute to audit and inspection readiness by participating in internal audits, self-inspections, GMP walk-throughs, and continuous compliance activities across the site.

What You'll Bring Required Qualifications Bachelor's degree in Science, Pharmaceutical Sciences, Biotechnology, Chemistry, Microbiology, Quality Management, or a related discipline. 2-3+ years of experience working in a Good Manufacturing Practice (GMP) or Good Distribution Practice (GDP) regulated environment.

Experience supporting quality systems, investigations, deviations, CAPAs, change controls, or compliance-related activities. Strong problem-solving, analytical, and root cause investigation skills with the ability to make sound, data-driven decisions. Excellent communication and collaboration skills, with the ability to build effective partnerships across multiple functions.

Strong attention to detail and a commitment to maintaining high standards of quality, accuracy, and compliance. Ability to manage multiple priorities while meeting timelines in a regulated manufacturing environment. Preferred Qualifications Experience within pharmaceutical, compounding, biotechnology, medical device, or healthcare manufacturing environments.

Knowledge of regulatory requirements and industry standards, including GMP, GDP, quality risk management, and quality systems. Experience participating in internal, customer, or regulatory audits and inspections. Familiarity with validation, qualification, stability programs, product quality reviews, or supplier quality processes.

Experience supporting continuous improvement initiatives using quality and operational performance metrics. Why Baxter? At Baxter, our mission is deeply connected to the patients, healthcare professionals, and communities we serve. When you join our team, your work helps ensure that critical therapies are delivered safely and reliably to those who depend on them.

You'll collaborate with talented colleagues, contribute to meaningful innovation, and have opportunities to grow your career while making a lasting impact on healthcare worldwide. #LI-LR1 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.

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