Pharma Quality Inspector — Precision & Compliance

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

Benefits offered by this job

ESPP

401(k) plan

Health insurance

Paid time off 20–35 days

Job summary

Baxter International Inc. in the United States is seeking a Quality Inspector to endorse process and product quality through routine assessments of plant operations, incoming inspection, and finished product inspection.

You will ensure regulatory adherence and participate in the release of devices and components while supporting continuous quality improvements. The role requires a high school diploma with 2–4 years of related experience, familiarity with cGMP/FDA requirements, and strong

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.
• Good communication skills.
• Ability to visually inspect and identify particulate/foreign matter as required by FDA.

Responsibilities

• Perform the inspection of DHR documentation for devices and modules to ensure procedures are completed and release specs met.
• Perform internal inspection of devices for visual conformity including labels prior to release.
• Verify that customer-facing device labels match the serial number being inspected.
• Approve device/module release in ERP system as applicable.
• Ensure no open nonconformances exist in NCR system (SAP).
• Review event history log to ensure data is correctly entered.
• Record failing observations using minor correction or nonconformance systems.
• Disposition rework and close non-conformances in approved systems.
• Ensure process control and maintenance procedures are followed.
• Recognize out of tolerance situations and take action.
• Add QA flags to received product in ERP system.
• Inspect and release Spare Parts Kits QA checks.
• Assist identification and containment of nonconforming product for investigations.

Skills

Attention to detail

cGMP knowledge

Visual inspection

Communication skills

Measurement equipment

Education

High School diploma + 2-4 years

Tools

GMP documentation

Job description

Baxter International Inc. in the United States is seeking a Quality Inspector to endorse process and product quality through routine assessments of plant operations, incoming inspection, and finished product inspection.

You will ensure regulatory adherence and participate in the release of devices and components while supporting continuous quality improvements. The role requires a high school diploma with 2–4 years of related experience, familiarity with cGMP/FDA requirements, and strong