Job Description

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

• Education: This role requires strong work experience in analytical and sterility assurance testing technologies with a BSc or higher in chemistry, industrial engineering or related fields. Advanced degrees or additional certifications in relevant field preferred.
• Experience: At least 7-10 years of experience in a leadership role within pharmaceutical or biotechnology industries and 3-5 years of leadership role in raw material testing and release. Significant experience working in a Good Manufacturing Practice (GMP) and Good Laboratory Practices (GLP) environment is crucial. Proficiency in quality control software including LIMS and data analysis tools.
• Skills: Proficiency in analytical techniques such as High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC) and mass Spectrometry (MS). Knowledge of Endotoxin and Sterility Assurance test methods.

Salary: $125-140K/yr

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