Quality Systems Engineer: CAPA & CI Leader

Katalyst-Healthcares-; Swiftwater (Monroe County); On-site; USD 85,000 - 130,000; Full time

Job summary

The Katalyst-Healthcares- Quality Systems Engineer will support pharmaceutical manufacturing operations, focusing on Formulation and Filling, in Monroe County, Swiftwater, PA. You will drive CAPA, Change Control, quality investigations, and root cause analysis while ensuring cGMP compliance.

You will collaborate across Quality, Operations, Engineering, MSAT and Sterility Assurance to enable continuous improvement using Lean, Six Sigma, and visual management principles, with strong technical

Qualifications

• Bachelor's degree in a relevant science or engineering field.
• Minimum 3–5 years in pharmaceutical manufacturing or Quality Systems.
• Strong knowledge of cGMP and regulatory requirements.

Responsibilities

• Lead CAPA and Change Control actions with timely closure.
• Perform quality investigations and root cause analyses.
• Collaborate with cross-functional teams to resolve issues.
• Provide technical support for eBR, OEE, and qualification activities.
• Contribute to Lean and Six Sigma continuous improvement.
• Prepare and maintain protocols, investigations, and change controls.

Skills

Cross-functional communication

Problem-solving

Project management

Education

Bachelor's degree

Tools

Excel

Word

PowerPoint

iShift

Qualipso

eBR

Opstrakker

Job description

The Katalyst-Healthcares- Quality Systems Engineer will support pharmaceutical manufacturing operations, focusing on Formulation and Filling, in Monroe County, Swiftwater, PA. You will drive CAPA, Change Control, quality investigations, and root cause analysis while ensuring cGMP compliance.

You will collaborate across Quality, Operations, Engineering, MSAT and Sterility Assurance to enable continuous improvement using Lean, Six Sigma, and visual management principles, with strong technical