Qc Analyst I – Raw Materials

Overview

• The QC Analyst I – Raw Materials supports GMP manufacturing by coordinating raw material sampling activities.
• This role involves tracking incoming materials, planning sampling, and reviewing external test results.
• Maintains laboratory spaces and ensures compliance with GMP requirements and contamination control procedures.
• Requires routine aseptic gowning and entry into classified cleanroom environments.
• Ensures sampling activities are performed accurately and on schedule to support manufacturing timelines.
• Collaborates with Warehouse Operations for sample logistics and material movement.
• Supports deviation, investigation, and CAPA activities related to sampling operations.
• Works cross-functionally with QC, Warehouse, Manufacturing, Quality Assurance, and external partners.

Key Responsibilities & Duties

• Perform GMP sample collection, labeling, and chain-of-custody documentation.
• Coordinate sample logistics, including shipment to Contract Testing Laboratories.
• Maintain inspection-readiness in QC owned areas through routine cleaning and upkeep.
• Serve as a qualified trainer for Raw Material Sampling Area.
• Review, reconcile, and upload external laboratory results into internal systems.
• Support Warehouse operations with material movement activities.
• Assist with deviation, investigation, and CAPA activities as needed.
• Ensure compliance with GMP and aseptic handling procedures.

Job Requirements

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