Manufacturing Lead Operator - Aseptic (3rd Shift)

Job description

Core Hours Sunday - Wednesday, 5:00 pm - 5:30 am Purpose and Scope: The Aseptic Lead Operator supervises and leads processes including set-up and operation of processes related to supporting the injectable team, while ensuring that products are made with quality for our patients. Key Responsibilities: - Perform job responsibilities in accordance with standard operating procedures (SOPs) and production records with an expectation of "Right the First Time". - Perform job in a clean room environment requiring clean room gowning, including but not limited to: - Company-provided Scrubs - Shoe Covers and Sterile Boot Covers - Hairnets (and beard covers as applicable) - Tyvek Coveralls - Gloves - Full-face masks/hoods - Goggles - Chemical Protection PPE - Setup and manufacture (bulk, fill, stopper, label, and package) clinical supplies and commercial pharmaceutical products in an aseptic environment in accordance with production batch records. - Set-up and operate semi-automatic filling equipment used to fill syringes for injectable products in both general manufacturing and sterile manufacturing areas. - Perform routine sampling and inspections of pre-filled syringes for injectable produ...