Qc Analyst I – Raw Materials

Overview

• Support GMP manufacturing by managing raw material sampling activities, ensuring compliance with regulatory standards and production timelines.
• Coordinate sampling logistics, including tracking incoming materials and reviewing external test results for accuracy.
• Maintain laboratory spaces, adhering to GMP requirements and contamination control procedures.
• Perform routine aseptic gowning and operate within classified cleanroom environments.
• Collaborate with cross-functional teams to ensure seamless sampling operations and material movement.
• Contribute to deviation investigations and CAPA activities related to sampling processes.
• Enhance operational efficiency by supporting quality assurance and manufacturing teams.
• Participate in continuous improvement initiatives to optimize sampling workflows.

Key Responsibilities & Duties

• Conduct GMP sample collection, labeling, and documentation to ensure traceability.
• Coordinate sample shipment logistics to external Contract Testing Laboratories.
• Maintain inspection-readiness of QC areas through regular cleaning and organization.
• Act as a qualified trainer for the Raw Material Sampling Area.
• Review and reconcile external laboratory results, uploading them into internal systems.
• Support Warehouse operations with material movement and logistics.
• Assist in deviation investigations and CAPA activities to address sampling issues.
• Ensure adherence to GMP and aseptic handling protocols during all operations.

Job Requirements

• Bachelor of Science (BS) degree in a relevant field is required.
• Minimum of 1 year of experience in GMP, pharmaceutical, or biotech environments.
• Preferred 5 years of experience in raw material sampling and GMP documentation.
• Familiarity with QMS Systems (e.g., Veeva) and Oracle is advantageous.
• Strong organizational, communication, and time-management skills are essential.
• Ability to work independently and manage multiple priorities effectively.
• Physical capability to perform tasks involving lifting, climbing, and extended standing.
• Compliance with PPE requirements and cleanroom protocols is mandatory.