Quality Inspector (2nd shift)
Baxter International Inc.
Summary
You will be responsible for endorsing process and product quality, efficacy, and safety through the routine assessment of plant operations, incoming inspection and finished product inspection. Responsible for ensuring adherence to the regulatory and procedural requirements that govern those operations and products.
Job description
What You'll Be Doing
- 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.
What You'll Bring
- 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 equipment, cGMP documentation and FDA, basic ESD requirements, computer based programs, data entry and spreadsheet applications.
Requirements
- 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.
- 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 equipment, cGMP documentation and FDA, basic ESD requirements, computer based programs, data entry and spreadsheet applications.
Benefits
- Medical coverage
- Dental coverage
- Life insurance
- Accident insurance
- Short-term disability
- Long-term disability
- Business travel accident insurance
- Employee stock purchase plan
- 401k retirement savings plan
- Flexible spending accounts
- Educational assistance
- Paid holidays
- Paid time off
- Paid parental leave
- Commuting benefits
- Employee discount program
- Employee assistance program
- Childcare benefits
Company overview
Baxter International Inc. is an American multinational healthcare company headquartered in Deerfield, Illinois, founded in 1931. As a leading global medical device manufacturer, Baxter specializes in developing and producing essential medical products for treating chronic and acute medical conditions. The company operates across three primary business segments: Medical Products and Therapies, Healthcare Systems and Technologies, and Pharmaceuticals. Baxter's extensive product portfolio includes intravenous (IV) solutions, infusion pumps, dialysis equipment for kidney disease treatment, surgical technologies, and hospital pharmaceuticals. With approximately 38,000 employees worldwide and annual revenues exceeding $10 billion, Baxter plays a critical role in global healthcare infrastructure. The company is particularly known for its leadership in IV fluid production, manufacturing approximately 60% of the intravenous fluids used in the United States. Baxter's innovations include pioneering developments in artificial kidney technology and advanced surgical products, serving healthcare providers across more than 100 countries. The company maintains a strong commitment to research and development, investing significantly in medical technology advancements that improve patient outcomes and healthcare delivery efficiency.