Baxter
Healthcare
Inspector,FinalQA
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Inspector, Final QA at Baxter. Skills: Final QA inspection, Documentation review, Device inspection. Perform inspection of ICL documentation. Ensure test procedures have been completed”
Industry & Context.
Recognize out of compliance situations; Recognize out of tolerance situations; Take appropriate action
Wear static protective smock, Wear ground wrist strap, Work in close proximity to other employees, Work in temperature controlled environment, Work in humidity controlled environment, May be required to work flexible hours, May be required to work overtime on short notice
What They're Looking For.
Must Have
Bachelors degree with 0-2 years experience or Associates with 1-3 years experience or High School diploma with 2-4 years experience, Familiar with cGMP, Familiar with FDA requirements, Knowledge of measurement equipment, Knowledge of basic ESD requirements, Knowledge of computer based programs, Knowledge of data entry, Knowledge of spreadsheet applications, Ability to perform repetitive motions with hands/fingers, Knowledge of cGMP documentation, Knowledge of FDA required documentation, Demonstrated attention to details, Demonstrated accuracy, Good communication skills, Ability to sit for most of the work day, Ability to stand or walk for long periods, Ability to lift and carry at least 20 pounds, Good hand to eye coordination, Good dexterity
Nice to Have
Experience in a pharmaceutical or Biotech industry helpful, Knowledge of aseptic techniques may be required
What You'll Do.
Perform inspection of ICL documentation
Ensure test procedures have been completed
Ensure release specifications are within specifications
Perform internal inspection of devices
Ensure visual aspects of the pump are met
Verify customer facing device labels are accurate
Verify packing labels are accurate
Approve release of device in ERR system
Ensure no open nonconformances exist
Review event history log
Ensure calibration values have been accurately entered
Channel accepted products to appropriate locations
Channel rejected products to appropriate locations
Record failing observations using minor correction process
Record failing observations using electronic nonconformance system
Disposition rework activities of nonconformances
Complete electronic approval and closure process for non-conformances
Review for accuracy quality data entry
Accept quality data entry of service events
Ensure process control procedures are followed
Ensure maintenance procedures are followed
Recognize out of compliance situations
Recognize out of tolerance situations
Take appropriate action for non-compliance
Add QA flags to received product
Inspect QA release activities of Spare Parts Kits
Perform QA release activities of Spare Parts Kits
Assist with identification of nonconforming product
Assist with containment of nonconforming product
Perform other duties as assigned
How You'll Work.
Communication Scope
Good communication skills
Full Job Description
**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. **Your Team** Baxter is focused on saving and sustaining lives by manufacturing high-quality products. We strive to create quality products for our customers each day. Delivering life-saving products is about getting them right, and attention to detail is how we make sure we meet that challenge. We are a team that supports each other throughout each shift. Working together in a supportive and open culture makes our processes evolve for the better and engages our workforce. **What you’ll be doing** * Perform the inspection of ICL documentation for infusion pumps (devices) and wireless battery modules either on paper or in the electronic Global Service Platform (GSP) system 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 pump or wireless battery module, including approved labels, are met prior to release of device or wireless battery 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 wireless battery modules in the a
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