GMP & FDA-Driven Quality Inspector

Baxter; Skaneateles Falls (NY); On-site; USD 45,000 - 62,000; Full time

Benefits offered by this job

Medical and dental

ESPP

401(k) with match

Paid time off (20–35 days)

Educational assistance

Job summary

Baxter is seeking a Quality Inspector to endorse product quality, efficacy and safety through routine plant inspections, DHR reviews and final product release. You will ensure regulatory compliance, proper labeling, and accurate data entry while supporting continuous improvement in a manufacturing environment.

The role requires strong attention to detail, knowledge of GMP/FDA requirements, and the ability to work with ERP systems.

Qualifications

• 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 GMP documentation and FDA required.
• Demonstrated attention to details and accuracy required.

Responsibilities

• Perform the inspection of DHR documentation for devices and modules to ensure test procedures are complete and release specs are met.
• Perform internal inspection of devices to ensure visual and labeling requirements are satisfied prior to release.
• Verify accuracy of customer facing device and packing labels against serial numbers.
• Approve device/module release in the ERP system.
• Ensure no open nonconformances exist in the NCR system (SAP).
• Review event history logs to ensure data are accurately recorded.
• Record failing observations and manage nonconformances via corrective processes.
• Dispostion rework activities and close non-conformances in the system.
• Ensure process control and maintenance procedures are followed.
• Recognize out of tolerance situations and take action.
• Add QA flags to all received product in ERP.
• Inspect and release Spare Parts Kits; assist in containment of nonconforming product.

Skills

Attention to detail

Quality inspection

Documentation integrity

Communication skills

FDA/cGMP knowledge

Education

High School diploma

Tools

SAP

ERP systems

Job description

Baxter is seeking a Quality Inspector to endorse product quality, efficacy and safety through routine plant inspections, DHR reviews and final product release. You will ensure regulatory compliance, proper labeling, and accurate data entry while supporting continuous improvement in a manufacturing environment.

The role requires strong attention to detail, knowledge of GMP/FDA requirements, and the ability to work with ERP systems.