Manufacturing Lead Operator - Specialty Injectables (3rd Shift)
Tolmar · Windsor, Colorado, US
Core Hours Monday - Friday 10:00pm - 6:30am Purpose and Scope The Manufacturing Lead Operator – Specialty Injectables supervises and leads processes, includi...
Job description
Core Hours Monday - Friday 10:00pm - 6:30am Purpose and Scope: The Manufacturing Lead Operator – Specialty Injectables supervises and leads processes, including set up and operation of processes related to supporting the Specialty Injectable team, while ensuring that products are made with quality for our patients. Leads may have a primary focus of either Injectables (Sterile Filling/Bulking) or Bulking (Polymer) or both. 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 - Issuance of bulk materials. - Perform facility cleaning of manufacturing areas as required to maintain a cGMP environment and following Tolmar Standard Operating Procedures. - Perform final review of processes before the processes can be considered complete. - Properly perform job duties as a se...