Manufacturing Lead Operator - Aseptic (3rd Shift)

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".
  • Work 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 products.
        • Set-up and operate compounding equipment used to produce bulk material for injectable products.
          • Biological sampling of general manufacturing clean room facilities.
            • Set-up and operate semi-automatic packaging equipment used to package pre-filled syringes.
              • Document production activities using regulatory controlled documents including production records and log books.
                • Accurately perform facility cleaning of manufacturing areas as required to maintain a cGMP environment and by TOLMAR Standard Operating Procedures.
                  • Perform visual and physical inspections of in-process and finished product as requested.
                    • Responsible for assembly, disassembly and sanitation of various equipment.
                      • Properly perform job duties as a second-checker, ensuring all production activities are correctly performed per batch production records.
                        • Responsible for quality of product.
                          • Train other Aseptic Operators and Technicians in the Injectable Products team to perform job duties related to their position.
                            • Handle hazardous raw materials and cleaning solutions following all applicable safety procedures and policies.
                              • Formulate bulk materials.
                                • Maintain proper use of aseptic techniques.
                                  • Operate under the minimal supervision of a Supervisor.
                                    • Perform other duties as assigned.