Manufacturing Associate II; DP; Packaging - Rotating 1st & 2nd shift

The Drug Product Manufacturing Associate II is a regular employee in a full-time non-exempt position at Kashiv Bio Sciences, LLC, in Chicago, IL. This employee will be responsible for the manufacturing of Biotechnology products for clinical and commercial human use. Must comply with Kashiv Bio Sciences policies, procedures (SOP), FDA current Good Manufacturing Practices (cGMP), and any other government requirements.

• To take Line Inspection/Line clearance of the Packaging area.
• To operate the syringe labeling machine, label counting, blister packaging, Autoinjector Assembly and labeling machine, check weigher, Semi-Automatic cartonator machine, serialization, aggregation, and tamper-evident sealing Machines by following respective SOP.
• To visually inspect labeled syringes, labeled autoinjector devices, blister packs, printed cartons, or shippers for any defects.
• Responsible for submission of samples.
• To participate in investigations if needed.
• To pack syringes with other necessary components manually in cartons.
• To check the weight of cartons to ensure there are no missing components.
• To pack good cartons into the shipper and do palletization.
• To submit documents and material requests to start packaging operations to the respective department.
• To verify all drug product syringes before starting packaging activity.
• To electronically record all the process steps (If required).
• To complete logbooks, Batch Records, and other cGMP documentation accurately and in a timely manner.
• To remove and dispose of soiled / expired, rejected syringes and materials from the area.
• To ensure that the packaging rooms and surrounding areas are maintained within the required conditions for clean room manufacturing.
• To report all nonconformance or events that arise during the shift to the Supervisor.
• To comply with all safety, cGMP and Company policies, practices, and procedures.
• To perform other functions (Manufacturing, Visual inspection) as required or assigned.
• To comply with all company policies and standards.