Quality Associate III

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.

• Generation of electronic protocols / study building / data entry / data review in LIMS, maintaining study files, preparation of stability reports for registration, annual product review and annual reports for regulatory submissions.
• Perform stability assessments to support laboratory investigations, product complaints, change controls and stability chamber excursions.
• Develop stability study designs for new product development and sustaining product projects. Contribute to technical feasibility analysis of complex research and design concepts. Evaluate results relative to product requirements, definitions and / or program goals.
• Independently plan and execute a series of stability study designs and / or technical tasks that may not be well-defined, have multiple variables, and require advanced techniques within negotiated deadlines. Play a lead role in the evaluation, selection and adaptation of various techniques / strategies, which accomplish business objectives such as quality and cycle-time.
• May provide training and supervision to junior members within the discipline. Routinely provide advice and assistance to team members regarding unique problems.
• Devise new approaches to complex problems through adaptations and modifications of standard technical principles. Incorporate new methods and technologies for improving existing or new products / processes.
• Maintain current knowledge of relevant QSRs and other regulatory requirements, such as the stability related ICH guidelines, for R&D (product development, design, and safety) to ensure compliance in all research, data collection and reporting activities.
• Displays a solid understanding of theories / practices utilized by other disciplines outside the primary area of expertise. In addition to having an in-depth knowledge and understanding of cGxP and related regulations and guidance, is able to provide expert advice and / or is an active participant in the generation, review, adoption, and interpretation of such regulations.
• Develop budgets and activity schedules of limited scope. Maintain focus on meeting both external and internal customer expectation.

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

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Skills Required

Lims, Regulatory Submissions