Quality Inspector

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.

BUSINESS TITLE Inspector, Final QA DEPARTMENT Quality

JOB TITLE Inspector, Final QA REPORTS TO Manager, Operations Quality

JOB CODE 10-Step-USA
01-Inspector-300483 VERIFIED BY Human Resources

GRADE/FLSA HNE REVISION DATE 2/23/2021

This document outlines the employment prerequisites and job responsibilities for the Inspector, Final QA position

• 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.
• Approves 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.
• Perform other duties as assigned.

• Knowledge and working application of the following:
• Measurement equipment.
• cGMP documentation and FDA
• Basic ESD requirements
• Computer based programs
• Data entry and spreadsheet applications.
• Perform repetitive motions with hands/fingers.
• Demonstrated attention to details and accuracy, required.
• Must have good communication skills.
• May be required to work flexible hours and overtime on short notice.
• Ability to visually inspect and identify particulate/foreign matter and distinguish between colors as required by FDA Current Good Manufacturing Practices

• Ø High School diploma or GED
• Ø Preferred experience in a pharmaceutical or Biotech industry helpful.
• Ø Must be familiar with cGMP and FDA requirements.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations…