Manufacturing Specialist: Process & Quality Improvements

ProQuality Network; Northern (KY); Hybrid; USD 65,000 - 90,000; Full time

Job summary

ProQualityNetwork is seeking a Specialist, Manufacturing to support the execution of manufacturing and quality systems, including non-conformances, process validation, procedures, training, and new product introductions. The role applies process, operational, and scientific expertise, as well as compliance knowledge, analytical skills, and troubleshooting capabilities to support manufacturing operations.

The Specialist may serve as a primary process owner for production systems and assist with

Qualifications

• Experience writing and revising SOPs and training materials.
• Experience with manufacturing equipment and process operations.
• Ability to develop new SOPs and deliver training to personnel.

Responsibilities

• Initiate, revise, and approve manufacturing procedures aligned with operations.
• Serve as document owner and maintain controlled documentation.
• Assess process performance through observation and data review; implement improvements.
• Provide technical and troubleshooting support to operations.
• Assist in creating training materials and delivering process training.
• Support process monitoring parameters, data collection, and deviation assessments.
• Assist in NC/CAPA triage and closure and review root cause analyses.
• Support development and execution of process validation protocols and reports.
• Participate in regulatory inspections as required.
• Support NPI activities and equipment modification requirements.
• Assist CCRB packages for production changes.
• Contribute to special projects or continuous improvement initiatives.

Skills

SOP writing

SOP revision

Training delivery

Process improvement

Analytical skills

Troubleshooting

Education

Master's degree

Bachelor's degree

Associate's degree

High school diploma/GED

Job description

ProQualityNetwork is seeking a Specialist, Manufacturing to support the execution of manufacturing and quality systems, including non-conformances, process validation, procedures, training, and new product introductions. The role applies process, operational, and scientific expertise, as well as compliance knowledge, analytical skills, and troubleshooting capabilities to support manufacturing operations.

The Specialist may serve as a primary process owner for production systems and assist with