Overview
This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives.
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Support for Parents
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Continuing Education/
Professional Development -
Employee Health &
Well-Being Benefits -
Paid Time Off
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2 Days a Year to Volunteer
Success Profile
What makes a successful Quality team member at Baxter? Take a look at some of the top traits we’re looking for and see if you’re a fit.
- Detail Oriented
- Continuous Learner
- Courageous
- Collaborative
- Critical Thinker
- Influential
Senior Specialist, QA
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.
- Essential Duties and Responsibilities. This section contains a list of five to eight primary responsibilities of the work. The incumbent will perform other duties as assigned.
Product Complaint Related Matter/Non-Conformances/Product Recalls/FAs (Vietnam and Myanmar)
- Responsible for complaint related processes and ensure procedure compliance.
- Responsible for the completion of Product Complaint reporting to ensure notification to Complaint Coordinator within required timeframe and investigation of returned samples to determine root cause.
- Immediate follow-up of potential Medical or Adverse Event product complaints according to corporate requirements.
- Report, follow-up and trend product complaints.
- Responsible for FA related actions viz. customer notification letters, regulatory reporting and product recall activities.
- Reply to customer complaint, queries related to quality, presentation to customer on quality.
Quality Operation
- Responsible for release of Finished Goods with temperature controlled and after routine redressing.
- Disposition of Damage products
- Responsible for redressing instruction.
Document Management
- Documentation control and maintenance of records (record retention) and ensure compliance with Regulatory Requirements, Good Documentation Practices (GDP) and Standard Operating Procedures (SOPs).
- Oversee documentation to ensure completion of records and GDP Compliance
- Prepares SOP, Document Change Request (DCRs) and Periodic Review.
Internal Requirements and Improvements
- Ensure compliance with SOPs, quality assurance, internal and local regulations.
- Responsible for managing suppliers with the support of supplier quality function.
- Assist with data gathering and analysis for Quality Reviews/Complaint to ensure occurs at required frequency.
Essential Duties and Responsibilities. This section contains a list of five to eight primary responsibilities of the work. The incumbent will perform other duties as assigned.
Product Complaint Related Matter/Non-Conformances/Product Recalls/FAs (Vietnam and Myanmar)- Responsible for complaint related processes and ensure procedure compliance.
- Responsible for the completion of Product Complaint reporting to ensure notification to Complaint Coordinator within required timeframe and investigation of returned samples to determine root cause.
- Immediate follow-up of potential Medical or Adverse Event product complaints according to corporate requirements.
- Report, follow-up and trend product complaints.
- Responsible for FA related actions viz. customer notification letters, regulatory reporting and product recall activities.
- Reply to customer complaint, queries related to quality, presentation to customer on quality.
- Responsible for release of Finished Goods with temperature controlled and after routine redressing.
- Disposition of Damage products
- Responsible for redressing instruction.
- Documentation control and maintenance of records (record retention) and ensure compliance with Regulatory Requirements, Good Documentation Practices (GDP) and Standard Operating Procedures (SOPs).
- Oversee documentation to ensure completion of records and GDP Compliance
- Prepares SOP, Document Change Request (DCRs) and Periodic Review.
- Ensure compliance with SOPs, quality assurance, internal and local regulations.
- Responsible for managing suppliers with the support of supplier quality function.
- Assist with data gathering and analysis for Quality Reviews/Complaint to ensure occurs at required frequency.
- Discipline to adhere with quality and compliance requirement.
- Must have good verbal and written communication skills
- Excellent teamwork and coordination skills
- Good sense of urgency and strong follow up
- Able to work independently with little or no supervision
- Discipline to adhere with quality and compliance requirement.
- Organized and high level of accountability on documentation
- Resourceful, self-reliant, self-motivated and confident.
- Language – English competency is a must
Education and/or Experience. Include the education and/or experience that is necessary to perform the job satisfactorily.
- ·Bachelor’s degree and above, majoring in pharmacy is an advantage.
- Minimum 5 years of work experience with quality role in a Healthcare setting, preferably in a MNC organization.
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.
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