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This is where new knowledge is discovered. Baxter’s Research and Development teams work cross functionally to innovate, develop and introduce creative solutions for patients needs globally. From Scientists to Engineers, your work creates the products that save and sustain lives.
Job Responsibility:
Perform biological risk assessments to determine biocompatibility testing required to demonstrate product safety
Document risk assessments in Baxter qualified systems such as Team Center Unified (TCU), Trackwise 8, Electronic Laboratory Notebook (ELN)
Generate protocols and reports for biocompatibility testing
Manage biocompatibility testing at external laboratories within budget and according to project landmarks
Serve as a study monitor for studies placed at external laboratories and review protocols and reports
Summarize biocompatibility testing in technical documents that may be used for regulatory filing
Develop knowledge and understanding of ISO 10993 series of standards for executing biological assays and toxicological risk assessments per ISO 10993-17 for medical devices
Develop knowledge of global compendia (EX: USP, EP, JP etc) supporting container closure systems registered as drugs
Author BEP/BER for regulatory submissions
Have a working knowledge and understanding of Good Laboratory Practice (GLP) / Good Manufacturing Practice (GMP) and related regulations and guidance
Requirements:
Perform biological risk assessments to determine biocompatibility testing required to demonstrate product safety
Document risk assessments in Baxter qualified systems such as Team Center Unified (TCU), Trackwise 8, Electronic Laboratory Notebook (ELN)
Generate protocols and reports for biocompatibility testing
Manage biocompatibility testing at external laboratories within budget and according to project landmarks
Serve as a study monitor for studies placed at external laboratories and review protocols and reports
Summarize biocompatibility testing in technical documents that may be used for regulatory filing
Develop knowledge and understanding of ISO 10993 series of standards for executing biological assays and toxicological risk assessments per ISO 10993-17 for medical devices
Develop knowledge of global compendia (EX: USP, EP, JP etc) supporting container closure systems registered as drugs
Author BEP/BER for regulatory submissions
Have a working knowledge and understanding of Good Laboratory Practice (GLP) / Good Manufacturing Practice (GMP) and related regulations and guidance