Quality Inspector — Pharma/Biotech QA & Compliance

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

Benefits offered by this job

Health insurance

401(k) Retirement Savings Plan

Employee Stock Purchase Plan

Job summary

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

You will ensure adherence to regulatory requirements and support accurate release decisions in a fast-paced manufacturing environment. The role emphasizes thorough documentation, precise measurements, and collaboration with the Quality team to maintain high safety and quality 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.
• 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 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.

Responsibilities

• 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.

Skills

Attention to detail

Communication skills

Quality mindset

Flexible hours

Manual dexterity

Team collaboration

Tools

Measurement equipment

GMP documentation

FDA requirements

ESD requirements

Spreadsheet software

Data entry systems

Job description

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

You will ensure adherence to regulatory requirements and support accurate release decisions in a fast-paced manufacturing environment. The role emphasizes thorough documentation, precise measurements, and collaboration with the Quality team to maintain high safety and quality standards