The individual assigned to daily operations will be responsible for the following tasks:

• Weighing and dispensing materials
• Operating the glasswasher and autoclave
• Preparing media and buffer solutions
• Participating in drug substance manufacturing
• Handling filtration systems
• Performing aseptic filling of glass vials and pre-fillable syringes
• Conducting visual inspections of glass vials and prefilled syringes

Key responsibilities include:

• Training and adhering to aseptic practices in the ISO 6 area
• Participating in media fill operations
• Handling secondary packaging, material issuance, and visual inspection
• Conducting in-process testing, such as pH and conductivity
• Verifying all raw materials and commodities
• Completing Batch Records and other cGMP documentation accurately and on time
• Removing and disposing of soiled materials from the manufacturing area
• Ensuring the manufacturing area is maintained within the required clean room conditions
• Reporting any nonconformances or events that occur during the shift to the Supervisor
• Complying with all safety, cGMP, and company policies, practices, and procedures
• Writing, reviewing, and recommending changes to cGMP documentation, including SOPs and Batch Records
• Assisting with the training of new employees
• Supporting coordination of activities as necessary