Process & Quality Manufacturing Specialist

Inteldot; Juncos (PR); Presencial; USD 70.000 - 100.000; Jornada completa

Descripción de la vacante

Inteldot in Puerto Rico seeks an Administrative Shift professional to support manufacturing/quality systems with emphasis on CAPA, non-conformances, process validation, and NPI. You will serve as a document owner, drive procedural improvements, and assist in regulatory readiness in collaboration with cross-functional teams.

The role requires strong analytical and troubleshooting skills, effective communication, and the ability to handle multiple stakeholders across sites.

Formación

• Knowledge in CAPA/CC/Risk Assessments/CDOC editor.
• Ability to initiate, revise, and approve manufacturing procedures.
• Experience supporting process validation and NPI processes.

Responsabilidades

• Initiate, revise, and approve manufacturing procedures; ensure procedures reflect current operations; serve as document owner.
• Assess process performance by observing floor operations and reviewing performance data; plan and implement improvements.
• Provide troubleshooting support for manufacturing operations.
• Assist in generation of training materials and training on scientific/technical aspects.
• Support establishment of process monitoring parameters and control limits; collect data and assess deviations.
• Assist with generation of process validation protocols and reports and execute validation.
• Participate in regulatory inspections, NPI, and process/equipment modifications.

Conocimientos

CAPA/CC/Risk assessments/CDOC editor

Effective communication

Cross-functional collaboration

Educación

Doctorate or Master's with 2 years manufacturing ops

Bachelor's with 4 years manufacturing ops

Associate's with 8 years manufacturing ops

High school/GED with 10 years manufacturing ops

Descripción del empleo

Inteldot in Puerto Rico seeks an Administrative Shift professional to support manufacturing/quality systems with emphasis on CAPA, non-conformances, process validation, and NPI. You will serve as a document owner, drive procedural improvements, and assist in regulatory readiness in collaboration with cross-functional teams.

The role requires strong analytical and troubleshooting skills, effective communication, and the ability to handle multiple stakeholders across sites.