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TOLMAR Inc. Manufacturing Technician I - Aseptic - Sun - Wed 1st shift in Windsor, Colorado

Core Hours: Sunday - Wednesday, 5:00 am - 5:30 pm; every other Wednesday off.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 ResponsibilitiesPerform job responsibilities in accordance with standard operating procedures(SOPs) and production records with an expectation of "Right the 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:Company-provided ScrubsShoe Covers and Sterile boot coversHairnets (and beard covers as applicable)Tyvek CoverallsGlovesFace maskGogglesChemical Protection PPEAssist in the set up and operation labeling equipment used to label pre-filledsyringes and/or vials, including equipment in the sterile support areas.Properly load pre-filled syringes and/or vials into labeling equipment.Assist in the set up and operation of semi-automatic packaging equipment usedto package pre-filled syringes.Properly load pre-filled syringes and components into semi-automatic packagingequipment.Accurately document production activities using regulatory controlleddocuments including production records and log books.Properly perform the Done By function on batch records in accordance to cGMPstandards.Identify need for minor maintenance on aseptic production equipment and assistwith set-up.Handle hazardous raw materials and cleaning solutions following all applicablesafety 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.Participate in required annual hazardous waste training. Hazardous wasteinvolvement may include, but is not limited to container and tank managementand inspections, generation of hazardous waste as a part of production orsampling processes and transfer of hazardous waste between lab procedurearea, satellite accumulation and storage. Respond to spills per the ChemicalSpill Procedures.Perform other duties as assigned.Special Skills and KnowledgeWorking 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.Attention to detail is required for documentation in production documents.Ability to be respirator-qualified and wear respirator for extended periods oftime (up to 4 hours) while performing cleaning of area.Capability to operate on a fast-paced manual assembly line using basicproduction equipment.Ability to manually assemble components.Ability to lift up to 40 lbs.Ability to lift arms above shoulder height repetitively for duration of shiftduring periods of area cleaning.Core ValuesThe Manufacturing Technician I - Aseptic is expected to operate within theframework of Tolmar's Core Values:Consistently operate with the highest standards of ethics and compliance.Take ownership of your actions, success and setbacks.Respect each other and understand that honest collaboration is at the heart ofour company success.Go the extra mile to make things happen.Be committed to all we do and the patients we serve.Embrace change with enthusiasm.Strive to learn about and understand the needs of customers and patients,

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