Assoc Scientist I-1
Job Summary
This is whereyour work makes a difference.
At Baxter we believe every personregardless of who they are or where they are fromdeserves 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 jobyou will find purpose and pride.
- 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.
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.
Required Experience:
IC
About Company
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 ... View more