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QC Raw Material Manager

Pennington, NJ 08534

Posted: 02/05/2025 Employment Type: Direct Hire/Perm Job Category: Quality and Compliance Job Number: 617604 Is job remote?: No Country: United States

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.
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About Pennington, NJ

Join us in exploring exciting job opportunities in the vibrant community of Pennington, New Jersey! Nestled in the picturesque Mercer County, Pennington offers a perfect blend of small-town charm and big-city amenities. With proximity to the beautiful Rosedale Park and Mercer Meadows, it's a haven for outdoor enthusiasts. Discover local art at the prestigious Morven Museum & Garden or catch a show at the Pennington Players Theatre. Indulge in delicious cuisine at the local farm-to-table restaurants or cheer on the Trenton Thunder baseball team at the Arm & Hammer Park. Embrace the unique culture and endless growth opportunities in Pennington – the perfect place to advance your career!

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