GMP Manufacturing Specialist: Process Excellence & NPI

ProQuality Network; Juncos (PR); Hybride; USD 70 000 - 100 000; Plein temps

Résumé du poste

ProQuality Network seeks a Specialist Manufacturing for onsite work in a GMP-regulated environment. The role focuses on supporting manufacturing processes, CAPA/NC management, change control, and continuous improvement projects.

Collaboration with Process Development, Engineering, and Quality is essential for success. The candidate will handle non-conformances, CAPAs, change control, process validation, training, and documentation, with strong analytical and technical writing skills required.

Qualifications

• Must meet one of the listed education/experience combinations.
• Experience in manufacturing ops in a regulated GMP environment is preferred.
• Strong knowledge of quality systems and regulatory requirements.

Responsabilités

• Support manufacturing processes and document control, ensure procedures reflect current operations.
• Monitor processes with data analysis and reporting.
• Lead NC/CAPA activities and trend monitoring.
• Assist with process validation protocols and reports.
• Support regulatory inspections and NPI activities.
• Participate in continuous improvement projects.

Connaissances

Bioprocessing

GMP experience

Cross-functional collaboration

Technical writing

Analytical thinking

Process optimization

Regulatory knowledge

Quality systems

Formation

Master's degree + 2 yrs manufacturing ops

Bachelor's degree + 4 yrs manufacturing ops

Associate degree + 8 yrs manufacturing ops

High School Diploma or GED + 10 yrs manufacturing ops

Outils

CAPA management

Change Control

SOP development

Process validation

Description du poste

ProQuality Network seeks a Specialist Manufacturing for onsite work in a GMP-regulated environment. The role focuses on supporting manufacturing processes, CAPA/NC management, change control, and continuous improvement projects.

Collaboration with Process Development, Engineering, and Quality is essential for success. The candidate will handle non-conformances, CAPAs, change control, process validation, training, and documentation, with strong analytical and technical writing skills required.