QC Raw Material Manager

Position Overview

Quality Control Raw Material Manager will ensure that the raw materials and consumables used in production meet the required quality standards.

Key Responsibilities

• Oversight : Oversee or execute the inspection, sampling and testing of incoming raw materials and consumables. Manage technology transfer of raw materials and consumables test methods.
• Compliance : Design and implement Raw Materials Qualification program in compliance with FDA and EMA regulations. Ability to conduct risk assessments and implement risk mitigation strategies for raw materials.
• Manage laboratory activities : Oversee or execute testing as needed on incoming raw materials and consumables, review the associated data, maintain accurate records of all inspections, test, vendor notifications and supplier evaluations.
• Problem Solving : Resolve technical problems in the lab. Lead investigation for out of specification results and deviations. Implement continuous improvement initiatives to optimize raw material testing and release.
• Team Leadership : Train laboratory personnel to ensure they are well versed in raw material and consumable test methods.
• Documentation : Author procedures, specifications, risk assessments, protocols and summary reports. Manage all raw material QMS documents including change controls.
• Data Management : Oversee the management and storage of raw material / consumable testing data, review to ensure it is accurate, securely stored and easily retrievable. Analyze data to identify trends and propose areas for improvement.
• Client and Audit Management : Subject matter expert in raw material / consumables for regulatory and client audits for GMP compliance.

Qualifications