Associate Manufacturing Operations

Job Description Responsibilities

• GMP fundamentals, Aseptic technique, qualified gowning and cleanroom behavior.
• Maintaining a clean, organized, and safe work environment (including cleaning/disinfecting equipment pre-use and post-use).
• Performing quality control checks, troubleshooting minor issues, and reporting deviations or problems to supervisors.
• Documenting processes, batch records, or data in compliance with regulations.
• Supporting process improvements, training runs, validation activities, or continuous improvement efforts.
• Operating and monitoring production equipment/machines (e.g., bioreactors, assembly lines, filling machines, or packaging systems).
• Setting up workstations, preparing raw materials, staging components, and verifying inventory/supplies.
• Assembling, producing, inspecting, testing, and packaging products according to standard operating procedures (SOPs).
• Executes manufacturing steps that directly impact product sterility and quality.

• Education:
  
  HS AA or BS
• Minimum Experience:
  
  0 years
• Preferred Experience:
  
  2 years
• Required Credentials:
  None
• Required Training: GMP basics, data integrity basics
• Knowledge of GMP, FDA regulatory expectations, data integrity (ALCOA), and applicable ICH/GxP principles.
• Computer Literacy: ERP systems, electronic document management systems, Microsoft Office Suite.