GMP Manufacturing Process Specialist

ECHO Consulting Group; Juncos (PR); On-site; USD 85,000 - 115,000; Full time

Job summary

ECHO Consulting Group is seeking a quality-focused professional to support manufacturing/QA systems in Puerto Rico. You will handle non-conformances, process validation, procedures, training, and new product introductions with minimal supervision.

Responsibilities include document ownership, process monitoring, CAPA closure, and collaboration across regulatory and manufacturing teams to ensure compliant operations. Fluency in English and Spanish is a plus for cross-functional roles.

Qualifications

• Doctorate, Master's, Bachelor's, Associate’s or High school with years of manufacturing ops experience as listed.
• Experience in manufacturing operations, process validation, non-conformance, CAPA, and NPI activities is preferred.
• Knowledge of GDP/GMP and regulatory inspections is expected.

Responsibilities

• Initiate, revise, and approve manufacturing procedures; own documents reflecting current operations.
• Support process monitoring and deviation assessment; assist quarterly reports.
• Prepare training materials and provide training on scientific/technical aspects of processes.
• Assist in generation and execution of process validation protocols and reports.

Skills

Technical writing

Cross-functional collaboration

GMP knowledge

Analytical troubleshooting

Process optimization

Regulatory interactions

Quality systems

Spanish language

English language

Project management basics

Education

Doctorate degree

Master's degree

Bachelor's degree

Associate’s degree

High school diploma / GED

Tools

Trackwise

Spotfire

CDOCS

Job description

ECHO Consulting Group is seeking a quality-focused professional to support manufacturing/QA systems in Puerto Rico. You will handle non-conformances, process validation, procedures, training, and new product introductions with minimal supervision.

Responsibilities include document ownership, process monitoring, CAPA closure, and collaboration across regulatory and manufacturing teams to ensure compliant operations. Fluency in English and Spanish is a plus for cross-functional roles.