Quality Inspector; 2nd shift

This is where your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives.

Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride.

This is where your creativity addresses challenges. You are creative, thorough, and a heads-down do-er. You embrace a challenge and truly apply the collaborative powers of your team to produce great results. You are motivated by work that is never the same from one day to the next. As a Quality Inspector you are unafraid of navigating through necessary internal processes to facilitate a product you deeply believe in.

You can absorb and act on complex procedures and data and train your team or peers if needed. You take pride in getting things done quickly without sacrificing safety or quality.

• Perform the inspection of DHR documentation for devices and modules either on paper in order to ensure test procedures have been completed and release specifications are within specifications for final device acceptance and release.
• Perform internal inspection of devices to ensure all visual aspects of the device or module, including approved labels, are met prior to release of device or module.
• Verify that all customer facing device and packing labels are accurate and match the serial number being inspected.
• Approve the release of the device and module in the appropriate ERP system, as applicable.
• Ensures there are no open nonconformances associates with device or module exist in the approved NCR system (SAP).
• Reviews the event history log within a device to ensure values have been accurately entered in the required testing values or results recorded in the DHR.
• Accurately record all failing observations using the minor correction process and/or electronic nonconformance system, as applicable.
• Dispositions the rework activities of nonconformances and completes the electronic approval and closure process for any non-conformances with the device in the approved electronic system.
• Ensure process control and maintenance procedures are being followed.
• Recognize out of compliance/out of tolerance situations and take appropriate action.
• Adding QA flags to all received product using the appropriate ERP system.
• Inspect and perform QA release activities of Spare Parts Kits.
• Assist with identification and containment of nonconforming product on the floor for internal investigations and holds.

• High School diploma with 2-4 years related experience.
• Experience in a pharmaceutical or Biotech industry helpful.
• Must be familiar with cGMP and FDA requirements.
• Knowledge of aseptic techniques preferred.
• Knowledge of GMP documentation and FDA required.
• Demonstrated attention to details and accuracy required.
• May be required to work flexible hours and overtime on short notice.
• Perform repetitive motions with hands/fingers.
• Demonstrated attention to details and accuracy, required.
• Must have good communication skills.
• Ability to visually inspect and identify particulate/foreign matter and distinguish between colors as required by FDA Current Good Manufacturing Practices.
• Knowledge and working application of: measurement…