GMP Manufacturing & Process Improvement Specialist

ProQuality Network; United States; Hybride; USD 90 000 - 120 000; Plein temps

Résumé du poste

ProQuality Network is seeking a Specialist Manufacturing to provide technical expertise in process monitoring, investigations, validation, change control, and continuous improvement within a GMP environment.

You will work cross-functionally with Manufacturing, Quality, Process Development, and Engineering to ensure compliant, reliable manufacturing performance and operational excellence. Strong Spanish/English communication and documentation skills are valued.

Qualifications

• Master’s degree with 2+ years of Manufacturing Operations experience.
• Bachelor’s degree with 4+ years of Manufacturing Operations experience.
• Associate degree with 8+ years of Manufacturing Operations experience.
• High School Diploma/GED with 10+ years of Manufacturing Operations experience.

Responsabilités

• Support manufacturing operations through process monitoring and continuous improvement.
• Author investigations, NCs, CAPAs and root-cause analyses.
• Monitor process performance, identify trends and recommend corrective actions.
• Maintain manufacturing procedures and GDP documentation.
• Assist with process validation activities and protocol development.
• Participate in change control and equipment modification implementations.
• Support New Product Introductions (NPI) and training.
• Contribute to quarterly process monitoring reports and trend analyses.
• Collaborate with cross-functional teams for inspections and audits.
• Participate in special projects and continuous improvement initiatives.

Connaissances

Manufacturing operations experience

Analytical thinking

Troubleshooting

Technical writing

Communication skills

Independent work

Project management

Collaboration

Formation

Master’s degree with 2+ years of Manufacturing Operations experience

Bachelor’s degree with 4+ years of Manufacturing Operations experience

Associate degree with 8+ years of Manufacturing Operations experience

High School Diploma/GED with 10+ years of Manufacturing Operations experience

Outils

TrackWise

Veeva

MES

SmartSheet

Power BI

Spotfire

CDOCS

Copilot

ChatGPT

Description du poste

ProQuality Network is seeking a Specialist Manufacturing to provide technical expertise in process monitoring, investigations, validation, change control, and continuous improvement within a GMP environment.

You will work cross-functionally with Manufacturing, Quality, Process Development, and Engineering to ensure compliant, reliable manufacturing performance and operational excellence. Strong Spanish/English communication and documentation skills are valued.