Quality Inspector – Pharma/Biotech QA

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

Benefits offered by this job

Health benefits

401(k) retirement plan

Paid time off

Job summary

Baxter in the United States is seeking a Quality Inspector to endorse product quality, safety, and process compliance across plant operations. You will inspect DHR documentation, verify labels and serial numbers, and release devices in the ERP system.

The role requires a high school diploma with related experience, familiarity with cGMP and FDA rules, and strong attention to detail. Expect flexible hours and potential overtime in a dynamic manufacturing setting.

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.
• 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 colors as required by FDA CGMP.
• Knowledge of measurement equipment, cGMP documentation and FDA, basic ESD, and data entry/spreadsheet applications.

Responsibilities

• Perform inspection of DHR documentation for devices and modules to ensure procedures completed and release specs met.
• Inspect devices for visual aspects and labels before release.
• Verify customer-facing device labels match serial numbers.
• Approve device/module release in ERP system.
• Ensure no open nonconformances in NCR system (SAP).
• Review event history log for accurate testing values and results in DHR.
• Record failing observations using minor correction or nonconformance systems.
• Dispostion rework and close non-conformances in ERP system.
• Ensure process control and maintenance procedures followed.
• Recognize out-of-tolerance situations and take action.
• Add QA flags to received product in ERP.
• Inspect and QA release Spare Parts Kits.
• Assist with containment of nonconforming product for investigations.

Skills

Attention to detail

Communication skills

Hand-eye coordination

Quality inspection

Education

High School diploma or equivalent

Job description

Baxter in the United States is seeking a Quality Inspector to endorse product quality, safety, and process compliance across plant operations. You will inspect DHR documentation, verify labels and serial numbers, and release devices in the ERP system.

The role requires a high school diploma with related experience, familiarity with cGMP and FDA rules, and strong attention to detail. Expect flexible hours and potential overtime in a dynamic manufacturing setting.