Associate Manufacturing Operations

Job Description

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.

Skills &

Experience · 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.