Manufacturing Quality Technician

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

Job Description

Provide quality and manufacturing support for production operations, supplier quality, validation, and process improvement initiatives. This role will assist with manufacturing transfers, quality system compliance, and continuous improvement efforts within a regulated production environment.

Provide quality and manufacturing support for production operations, supplier quality, validation, and process improvement initiatives. This role will assist with manufacturing transfers, quality system compliance, and continuous improvement efforts within a regulated production environment.

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.

Requirements

• 2+ years of experience in Manufacturing Quality, Quality Assurance, Supplier Quality, Process Quality, or Validation.
• Hands-on experience with CAPA, NCRs, quality documentation, inspections, and audit support.
• Familiarity with manufacturing quality systems, process validation, and regulated production environments.
• Strong documentation, organizational, and problem-solving skills.

Preferred Qualifications

• Experience in the medical device or other regulated manufacturing industry.
• Exposure to manufacturing transfers, process validation, supplier quality, or new product introduction (NPI) activities.
• Experience with respiratory care, ventilator, CPAP, sleep therapy, or similar healthcare products is a plus.