Research Associate II
4 weeks ago
Vantive: A New Company Built On Our Legacy
Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us.
At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us are driven to help improve patients’ lives worldwide. Join us as we revolutionize kidney care and other vital organ support.
*Completion of the proposed separation of Kidney Care from Baxter into a standalone company (to be named Vantive) remains subject to the satisfaction of customary conditions.
Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-center dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare.
Summary:
The Research Associate II of BELMAT (Biocompatibility, Extractable & Leachable, Material and Toxicology) will work with global cross functional teams to ensure compliance with various appropriate pharmacopoeias. The individual will monitor compendial web sites, prepare & share summary of new regulations, test methods and work with scientists to develop and track compendial compliance activities.
This is an opportunity to become part of a highly matrixed multidisciplinary team that is responsible for ensuring the safety of both drugs and medical devices for Peritoneal dialysis, Hemodialysis, and Acute therapies (~$5B product portfolio with global reach in more than 100 countries).
Job Responsibilities:
Monitor USP, BP, EP and Pharmeuropa compendial websites daily, determine which updates pertain to the products of interest to Kidney Care segment and distribute all updates to appropriate groups / stakeholders/ SMEs as identified by the organization. Be highly proficient and efficient in review/revision of product raw material, and test method assay documentation. Assist scientists in preparation/creation of product documentation and document change control package development. Monitor/track changes through Trackwise 8 change control system. Follow up with change assessors. Support product teams in the delivery of critical milestones by providing required documentation in an appropriate format and compliant with quality systems – including e.g., GMP as appropriate) in a timely manner. Perform technical quality checks as required. Prepare redlined documents and upload completed documents into appropriate systems. Create linkages for DHF files as required. Perform/assist in internal document assessments by collecting, organizing, summarizing, and analyzing information as requested. Assist in training staff, internal and external customers on documentation processes and systems. Ensure training records are met and are up to date.
Qualifications
Skilled in change control processes as practiced in healthcare industry document configurations/inter relationships and document management. Advanced proficiency in Word, EXCEL, Team Center for documentation, and TrackWise 8 software systems Strong organizational and negotiating skills Familiarity with technical matters in the space of Kidney Care products Excellent verbal and written communication skills in English Excellent problem solving skills Ability to work under strict deadlines amidst changing priorities with minimal supervision. Attention to details Ability to handle multiple high priority tasks with minimal supervision At least 5 years’ experience in working with compendial websites Aware of FDA regulations, application of Good Laboratory Practices and Good Manufacturing practices Good project management skills Adapt to changes and exhibit an agile mindset.
Education and/or Experience:
Master’s degree in Pharmaceuticals and 6 or more years of relevant experience in healthcare product data management/documentation systems or equivalent change control system Experience working with cross functional teams Knowledge of product/document configuration management Working knowledge of related business systems – including software, databases and quality systems
Skills
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