Regulated Manufacturing Quality & Process Specialist

Katalyst CRO; New Kensington (Westmoreland County); On-site; USD 60,000 - 80,000; Full time

Job summary

Katalyst CRO is seeking a Manufacturing Quality professional in New Kensington, PA to support quality operations, supplier quality, validation, and process improvement in a regulated production environment. You will collaborate with cross-functional teams, handle CAPA, NCRs, and documentation, and contribute to continuous improvement across manufacturing transfers and product launches.

Applicants should have 2+ years in related QA roles and strong problem-solving skills, with experience in

Qualifications

• 2+ years of experience in Manufacturing Quality, QA, Supplier Quality, or Validation.
• Hands-on with CAPA, NCRs, quality documentation, inspections, and audits.
• Familiar with manufacturing quality systems and regulated environments.
• Strong documentation and problem-solving skills.

Responsibilities

• Support daily manufacturing quality activities and ensure compliance with established quality standards.
• Assist with process validation, verification activities, and production readiness initiatives.
• Perform inspections, maintain quality documentation, and support process monitoring activities.
• Participate in CAPA, Non-Conformance (Client), deviation investigations, and corrective action tracking.
• Collaborate with Supplier Quality, Manufacturing Engineering, and Production teams to resolve quality issues and support ongoing manufacturing operations.
• Collect, analyze, and document quality metrics, validation results, and production data.
• Assist with internal audits, compliance initiatives, and continuous improvement projects.
• Support manufacturing process transfers, equipment qualifications, and product transition activities.

Skills

CAPA

NCRs

Documentation

Audit support

Tools

Quality systems

Job description

Katalyst CRO is seeking a Manufacturing Quality professional in New Kensington, PA to support quality operations, supplier quality, validation, and process improvement in a regulated production environment. You will collaborate with cross-functional teams, handle CAPA, NCRs, and documentation, and contribute to continuous improvement across manufacturing transfers and product launches.

Applicants should have 2+ years in related QA roles and strong problem-solving skills, with experience in