Manufacturing Process Investigator
Nephron Pharmaceuticals · West Columbia, South Carolina, US
Description Job Purpose: A Manufacturing Process Investigator is a professional who conducts thorough investigations into issues that arise within a manufact...
Job description
Description Job Purpose: A Manufacturing Process Investigator is a professional who conducts thorough investigations into issues that arise within a manufacturing environment, focusing on deviations, non-conformances, and other quality concerns. They aim to identify the root cause of these issues, implement corrective actions, and prevent recurrence, ultimately ensuring the quality and compliance of manufacturing processes. __________________________________________________________________________________________ Essential Duties and Responsibilities: Ø Use available resources to manage and track workload to meet required timelines. Ø Prepare thorough investigation reports, ensuring accuracy, completeness, and compliance with regulatory expectations. Ø Conduct root cause analysis (RCA) for deviations, product complaints, and quality-related incidents. Ø Work closely with production and quality teams to implement corrective and preventive measures based on investigation findings. Ø Develop and maintain technical documentation to support manufacturing and quality processes. Ø Develop CAPA plans with input from operators, Subject Matter Experts (SMEs), and management to ensure effecti...