Inteldot has over 14 years in the life science industry with allocations a cross Puerto Rico, United Sates, Europe and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.

Project Overview

With minimal supervision, support the execution of manufacturing/quality systems such as non-conformances, process validation, procedures, training, and new product introductions. Apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations. May serve as primary production process owner for process support systems and assist with process ownership responsibilities on more complex process systems.

Work Shift: Administrative

Responsibilities Assist manufacturing change owner on CCRB packages impacting the process.Participate in the NPI process to assess requirements for documentation, materials, training, and equipment modifications.Assess, prioritize, justify, and provide implementation and project management support for process or equipment modification projects.Assist with generation of process validation protocols and reports.Ensure that all Non-conformances are triaged within the established goal.Responsible for authoring investigation reports.Responsible for execution of corrective actions.Responsible for managing NC/CAPA closure within established goal. Competencies/Skills Strong Technical Writing and excellent written and verbal communication skills in English and Spanish.Experience in Root Cause AnalysisUnderstanding of bio-processing unit operationsCompliance/Regulatory knowledgeExperience with standard manufacturing procedures and GMP documentationAbility to communicate and collaborate with technical and management staff within manufacturing, process development, and quality Education Master's degree and 3 years of Manufacturing Operations experience OR Bachelor's degree and 5 years of Manufacturing Operations experience or Associate’s degree and 10 years of Manufacturing Operations experience or High school diploma / GED and 12 years of Manufacturing Operations experience.