TOLMAR Inc. Manufacturing Technician I - Aseptic in Fort Collins, Colorado
Purpose and ScopeThe Aseptic Technician I provides general support for the manufacturingdepartment with a focus on injectable products, while ensuring that ourproducts 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 Face masko Goggleso Chemical Protection PPE Assist in the set up and operation labeling equipment used to labelpre-filled syringes and/or vials, including equipment in the sterilesupport areas. Properly load pre-filled syringes and/or vials into labeling equipment. Assist in the set up and operation of semi-automatic packaging equipmentused to package pre-filled syringes. Properly load pre-filled syringes and components into semi-automaticpackaging equipment. Accurately document production activities using regulatory controlleddocuments including production records and log books. Properly perform the Done By function on batch records in accordance tocGMP standards. Identify need for minor maintenance on aseptic production equipment andassist with set-up. Handle hazardous raw materials and cleaning solutions following allapplicable safety procedures and policies. Maintain proper use of aseptic techniques. Perform facility cleaning of critical aseptic environment as required tomaintain a cGMP environment and in accordance with Standard OperatingProcedures. Ensure that product quality adheres to approved specifications. Operate under the direct supervision of a Lead Operator and/or AsepticSupervisor. Perform other duties as assigned.Requirements Special Skills and Knowledge Working knowledge of current Good Manufacturing Procedures (cGMP). Ability to stand for extended periods of time (up to 8 hours or more). Understanding of basic computer software. Ability to maintain focus on detail-oriented, repetitive tasks. Ability to follow and understand written production records and validationprotocols. Understanding of basic math and writing skills to document productionactivities in batch records and/or log books. Must be able to keep accurate records and able to perform mathematicalcalculations. Ability to legibly complete required documentation. Strong attention to detail required for documentation in productiondocuments. Capability to operate on a fast-paced manual assembly line using basicproduction equipment.Communication Interact with peers and members of other departments in team settings in aprofessional manner.Education & Experience High school diploma or equivalent required. Experience in a manufacturing environment preferred but not required.Additional Requirements Acceptable results on both a quantitative and verbal assessment test. Valid driver's license and acceptable motor vehicle record may be required. Shift work in a manufacturing and warehouse environment. May require overtime.Core hours are Monday through Friday 2:00 p.m. - 10:30 p.m.