QA In Process Engineer

  • Castlebar
  • Baxter
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.The role of the In Process Engineer is to review and process details associated with batches manufactured in Baxter Castlebar. This review and processing is required to allow these finished goods batches to be released to Baxter patient and customers. If this role is not filled the QA department will not be able to release these batches to the patients and customers.We are actively searching for QA in Process Engineer to join our team of wonderful people based in our Castlebar, Co. Mayo sites. The Castlebar and Swinford facilities employ more than 1300 staff, and we operate 24/7. You get the opportunity to work closely with multiple teams including Production, Chemistry, Engineering, and other support functions. What you will be doing: ·Achieve/Improve department KPIs & support plant goals with limited supervision·Review executed production batch records and provide deviation/batch dispositions·Investigate customer complaints ensuring that each complaint is addressed and closed in a timely manner·Ensure each NCR/deviation is investigated and documented and that appropriate corrective actions have been developed and implemented·Support process improvements·Regularly makes decisions which impact quality, time and/ or cost·Review and prepare SOPs, work instructions and other GMP documents·Proactively work within cross functional teams to address quality issue·Manage assigned projects and work within cross functionally teams·Support regulatory and compliance audits·Prepare and present quality management reportsWe are looking for someone that has: ·Takes accountability for results·Innovates and drives for solutions·Ability to deal with ambiguity·Critical thinking & problem solving skills·Team player and customer / results oriented·Ability to meet deadlines and effectively deal with workload·Ability to accurately communicate ideas, facts and technical information