Research Associate II, stability

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.  To provide support to the Stability Team in day to day technical and operational activities.  Develop stability study designs for new product development and sustaining product projects.  Without assistance, make sound technical recommendations regarding stability study designs for new product development and sustaining product projects that are more routine than not. Provide some analysis/redesign of key experimental procedures. Independently select techniques and procedures to solve problems within area of responsibility.  Employ appropriate techniques/methods to successfully and independently execute routine assignments related to stability study design and development within negotiated deadlines. Identify alternative methods and technologies for improving existing or new products/processes.  Maintain current/working 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.  Recommend appropriate study designs, techniques, and processes for a specified sequence of tasks where needed, including the use of LIMS systems for electronic stability protocols.  Contribute to technical feasibility analysis of complex products.  Demonstrate ability to apply technical theories and principles to projects within area of Expertise for nonroutine tasks. Analyse and determine best solutions to non-routine experimental design or research problems with minimal assistance. Accurately assess results for validity and conformance to specifications  Evaluate results relative to product requirements, definitions and/or program goals.  Providing technical rationale for expiration dating and label storage statement recommendations, preparing regulatory submissions, responding to regulatory communications.  Ensuring compliance related deliverables are completed on schedule and per plan.  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.  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, can be able to provide expert advice and/or is an active participant in the generation, review, adoption, and interpretation of such regulations.  Maintain focus on meeting both external and internal customer expectations.  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.  Providing technical rationale for expiration dating and label storage statement