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TOLMAR Inc. Lead Operator - Aseptic in Fort Collins, Colorado

Purpose and ScopeThe Aseptic Lead Operator supervises and leads processes including set-up andoperation 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". 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 Setup and manufacture (bulk, fill, stopper, label, andpackage) clinical supplies and commercial pharmaceutical products in anaseptic environment in accordance with production batch records. Set-up and operate semi-automatic filling equipment used to fillsyringes for injectable products in both general manufacturing and sterilemanufacturing areas. Perform routine sampling and inspections of pre-filled syringes forinjectable products. Set-up and operate compounding equipment used to produce bulk materialfor injectable products. Perform biological sampling of general manufacturing clean room facilities. Set-up and operate semi-automatic packaging equipment used to packagepre-filled syringes. Document production activities using regulatory controlled documentsincluding production records and log books. Accurately perform facility cleaning of manufacturing areas as requiredto maintain a cGMP environment and by TOLMAR Standard Operating Procedures. Perform visual and physical inspections of in-process and finishedproduct as requested. Responsible for assembly, disassembly and sanitation of various equipment. Properly perform job duties as a second-checker, ensuring allproduction activities are correctly performed per batch production records. Responsible for quality of product. Train other Aseptic Operators and Technicians in the Injectable Productsteam to perform job duties related to their position. Handle hazardous raw materials and cleaning solutions following allapplicable 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.Special Skills and Knowledge Mastered knowledge of current Good Manufacturing Procedures (cGMP). Ability to stand for extended periods of time (up to 8 hours or more). Proficient in Microsoft Office (Excel, Word, Outlook). Ability to maintain focus on detail-oriented, repetitive tasks. Excellent verbal and written communication skills to interact withSupervisors and colleagues. Adhere to written production records and validation protocols. Strong math and writing skills to document production activities inbatch records and/or log books. Excellent attention to detail for documentation in production documentsand to compare produced goods against specified requirements. Capability to operate on a fast-paced manual assembly line using basicproduction equipment. Ability to legibly complete required documentation.Core Values The Lead Operator - Aseptic is expected to operate within the frameworkof Tolmar s Core Values:o Consistently operate with the highest standards of ethics and compliance.o Take ownership of your actions, success and setbacks.o Respect each other and understand that honest collaboration is at theheart of our company success.o Go the extra mile to make things happen.o Be committed to all we do and the patients we serve.o Embrace change with enthusiasm.o Strive to learn about and understand the needs of customers andpatients, and take action with great speed and efficiency no matter the task.Communication Interact with peers and members of other departments in team settings ina professional manner. Provide consistent coaching, guidance, development and me

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