QC Manager

Vantive: A New Company Built on Our Legacy

Since last year, Baxter has been on a journey to separate our 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 sale of Vantive to funds managed by the Carlyle Group is subject to receipt of customary regulatory approvals and satisfaction of other closing conditions.

The QC Manager is responsible for the overseeing testing of release, raw materials, stability and investigational testing within Quality Control in both Chemistry and Microbiology at the manufacturing Liverpool site. This position will work closely with QA and plant management teams to assure material manufactured meets the registered specification and the test methods used are validated and compliant to the current pharmacopeia’s and maintained compliance with Baxter Corporate requirements.

Essential Duties and Responsibilities

• Responsible for the execution of Chemistry and Microbiology investigations on a plant-wide basis using the Trackwise system
• Initiates and drives Process Changes using the change control management process
• Maintains and updates SOPs
• Review of data and test records to Pharmacopeia / cGMP standards
• Supports and encourages their team with continuous improvements within the laboratory
• Responsible for maintaining external PM schedules/repairs and reviewing reports
• Timely reporting of Non-Conformances, Exceptions and Changes
• Responsible for maintaining the stability program including reporting
• Responsible for maintaining the EHS program within the laboratory
• Responsible for ensuring testing is scheduled and executed to meet the batch release cycle time.
• Responsible for Data Integrity and ALOCA+ within the Laboratory environment
• Responsible for the IOQ and validation of new instruments and methods within the QC footprint.
• Responsible for ensuring that all instruments meet CSV and data integrity requirements are routinely backed up and archived in line with global policies.

Education an Experience

• Science based education at degree level or equivalent in a Chemistry discipline.

• Extensive experience of working within a laboratory
• Experience in a healthcare manufacturing environment
• Relevant experience gained in a GLP / GMP environment and knowledge of current EU / FDA GMP regulations would be an advantage
• Preferably qualified to IOSHH
• Lean laboratory experience and proven ability to use and deploy lean tools
• Experience with Electronic Laboratory Information Management systems
• Experience with Data acquisition systems such as Empower3
• Experience in Data Integrity and ALCOA+

What are some of the benefits of working at Baxter Kidney Care (Vantive)?

• Competitive total compensation package
• Professional development opportunities
• High importance placed on work life balance
• Commitment to growing and developing an inclusive and diverse workforce

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Reasonable Accommodations

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