Senior QA Specialist

Baxter

Suzhou, Jiangsu
Permanent
Full-time

25 days ago

Vantive: A New Company Built On Our LegacyBaxter 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.Essential Duties and Responsibilities

Contribute to technical feasibility analysis of complex research and design concepts.
Evaluate results relative to product requirements, definitions and/or program goals.
Play a lead role in the evaluation, selection and adaptation of various techniques, which accomplish business objectives such as quality and cycle-time.
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 Quality System Regulations (QSR) and other regulatory requirements related to R&D (product development, design and safety) to ensure compliance in all research, data collection and reporting activities.
In addition to having an in-depth knowledge and understanding of GMP and related regulations and guidance, is able to provide expert insights into such regulations so as to facilitate efficient product registration and/or is an active participant in the generation, review, adoption and interpretation of such regulations.
Independently plan and execute a series of design and/or technical tasks that may not be well-defined, have multiple variables, and require advanced techniques within negotiated deadlines.
Lead Research project(s) serving as study director

o Design, write, and plan notebook studies and protocolso Conduct studies, document testing, read, and record resultso Organize and analyze datao Write study reportso Provide periodic updates to management on project status

Provide technical support for other laboratory testing as required

Qualifications

The position requires relevant laboratory skills, writing skills, and computer skills plus teamwork/interpersonal skills.
The candidate must be able to work independently with minimal instruction.
Knowledge of Quality System Requirements and Regulatory guidelines in Pharmaceuticals and Medical Devices
Experiences on sterility assurance, microbiological control/testing, and Moist heat/EO/Irradiation sterilization validation are preferred.
Bachelor's degree in a scientific discipline with at least 5-7 years or master's degree with at least 3-5 years relevant experience, or equivalent

Reasonable AccommodationsBaxter 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 here and let us know the nature of your request along with your contact information.Recruitment Fraud NoticeBaxter 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 .

Baxter

Apply Now