Quality Inspector – GMP/FDA, Flexible Hours

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

Benefits offered by this job

Medical & dental coverage

401(k) plan

Paid time off 20–35 days

Flexible spending accounts

Parental leave

Job summary

Baxter seeks a Quality Inspector to support FDA-regulated manufacturing. You will inspect DHR documentation, verify labels, and approve device releases in SAP to ensure conformity and traceability.

The role requires a High School diploma with 2–4 years of related experience, familiarity with cGMP/FDA requirements, and strong attention to quality. Overtime may be required; you will work in a manufacturing environment with strict standards.

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 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.

Responsibilities

• Perform the inspection of DHR documentation for devices and modules to ensure test procedures and release specs are met.
• Perform internal inspection of devices to verify labels and visual aspects before release.
• Verify customer facing device and packing labels match the serial number inspected.
• Approve the release of the device and module in the ERP system (SAP).
• Ensure there are no open nonconformances in the NCR system.
• Review event history logs to ensure data accuracy in testing values.
• Record failing observations using minor correction and/or NCR system.
• Dispositions rework activities and closes non-conformances in the system.
• Ensure process control and maintenance procedures are followed.
• Recognize out of tolerance situations and take appropriate action.
• Add QA flags to all received product in ERP.
• Inspect and perform QA release of Spare Parts Kits.
• Assist with containment of nonconforming product for investigations.

Skills

Attention to detail

Good communication

Visual inspection

Team collaboration

Education

High School diploma

Tools

SAP ERP

Job description

Baxter seeks a Quality Inspector to support FDA-regulated manufacturing. You will inspect DHR documentation, verify labels, and approve device releases in SAP to ensure conformity and traceability.

The role requires a High School diploma with 2–4 years of related experience, familiarity with cGMP/FDA requirements, and strong attention to quality. Overtime may be required; you will work in a manufacturing environment with strict standards.