TOLMAR Inc. Manufacturing Lead Operator - Aseptic Development in Windsor, Colorado

Purpose and ScopeThe Aseptic Development Lead supervises and leads processes including set upand operation of processes related to supporting the injectable team, whileensuring that products are made with quality for our patients.Key Responsibilities Perform job responsibilities in accordance with standard operatingprocedures (SOPs) and production records with an expectation of "Rightthe First Time". Record data in notebooks or lab forms and accurately calculate results tosupport process. Perform job in a clean room environment requiring clean room gowning,including but not limited to:o Company-provided Scrubso Shoe Covers and Sterile Boot Coverso Hairnets (and beard covers as applicable)o Tyvek Coverallso Gloveso Full-face masks/hoodso Goggleso Chemical Protection PPE Set up and operate semi-automatic labeling equipment used to labelpre-filled syringes. Properly load pre-filled syringes and/or vials into labeling equipment. Set-up and operate semi-automatic packaging equipment used to packagepre-filled syringes. Set up and operate semi-automatic filling equipment used to fill syringesfor injectable products in both general manufacturing and sterilemanufacturing areas. Properly load pre-filled syringes and components into semi-automaticpackaging equipment. Formulate bulk materials. Perform facility cleaning of manufacturing areas as required to maintain acGMP environment and following TOLMAR Standard Operating Procedures. Set up and operate compounding equipment used to produce bulk material forinjectable products. Perform final review of processes before the processes can be consideredcomplete. Properly perform job duties as a second checker, ensuring all productionactivities are correctly performed on batch records in accordance with cGMPstandards. Assist with equipment steam in place (SIP) on equipment used forsterile bulking processes. Ensure that product quality adheres to approved specifications. Assist and support any aseptic process development activities/projectsas determined by Aseptic Development Operations Manager. Handle hazardous raw materials and cleaning solutions following allapplicable safety procedures and policies. Correctly perform inspections of packaged components. Responsible for assembly, disassembly and sanitation of various equipment. Train other Manufacturing Operators and Manufacturing Technicians in theAseptic Development team to perform job duties related to their position. Review and maintain log books, production records, and associateddocuments to comply with regulatory requirements, GMPs, and TOLMARStandard Operating Procedures. Perform visual and physical checks of in-process and finished product asrequested. Perform biological sampling of general manufacturing clean room facilities. Perform 100% inspections of pre-filled syringes. Coordinate the daily tasks for Manufacturing Operators and Technicianswithin assigned process. Coordinate materials, staffing and resources to support line operationsand changeovers. Ensure that employees in assigned process follow safe work practices. Perform on floor, in process reviews of production batch records foraccuracy and resolve errors in real time. Operate under the guidance of a Manufacturing Manager. Perform other duties as assigned.Special Skills and Knowledge Mastered knowledge of current Good Manufacturing Procedures (cGMP) asthey relate to production packaging activities. Ability to stand for extended periods of time (up to 8 hours or more). Proficient in Microsoft Office (Excel, Word, and Outlook). Ability to maintain focus on detail-oriented, repetitive tasks. Good verbal and written communication skills. Ability to follow and understand written production records and validationprotocols. Strong understanding of basic math and writing skills to documentproduction activities in batch records and/or log books. Ability to keep accurate records and able to perform mathematicalcalculations. Ability to legibly