Responsibilities:

• Support clinical trial material manufacturing in a GMP environment: daily material needs, weighing, solution prep/testing, sample coordination, cleaning, material ordering, and tracking raw material usage.
• Create and update Solution Records, Work Instructions, SOPs, and other GMP documents.
• Review cleaning logbook forms for accuracy.
• Execute solution records under GMP regulations and SOPs, documenting all manufacturing activities accurately.
• Collaborate with Quality Assurance to meet quality goals and maintain high-quality processes.
• Maintain inventory, perform equipment maintenance and housekeeping.
• Participate in projects to improve service, quality, and efficiency.
• Follow safety rules when handling hazardous materials.
• Organize projects and data using Excel, Word, PowerPoint, and document control systems.
• Operate bioprocess equipment in compliance with cGMP, OSHA, and required policies/regulations.

Education/Skills Required:

• High School Diploma or equivalent with 18+ months of biopharmaceutical manufacturing experience in an FDA-regulated environment
• OR Associate's degree with 1+ year of related experience in an FDA-regulated environment
• OR Bachelor's degree in a scientific field with 6+ months of related experience in an FDA-regulated environment.