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

Key ResponsibilitiesPerform 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 ScrubsShoe Covers and Sterile Boot CoversHairnets (and beard covers as applicable)Tyvek CoverallsGlovesFull-face masks/hoodsGogglesChemical Protection PPESetup and manufacture (bulk, fill, stopper, label, and package)clinical supplies and commercial pharmaceutical products in an asepticenvironment in accordance with production batch records.Set-up and operate semi-automatic filling equipment used to fill syringes forinjectable products in both general manufacturing and sterile manufacturingareas.Perform routine sampling and inspections of pre-filled syringes for injectableproducts.Set-up and operate compounding equipment used to produce bulk material forinjectable 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 documents includingproduction records and log books.Accurately perform facility cleaning of manufacturing areas as required tomaintain a cGMP environment and by TOLMAR Standard Operating Procedures.Perform visual and physical inspections of in-process and finished product asrequested.Responsible for assembly, disassembly and sanitation of various equipment.Properly perform job duties as a second-checker, ensuring all productionactivities are correctly performed per batch production records.Responsible for quality of product.Train other Aseptic Operators and Technicians in the Injectable Products teamto perform job duties related to their position.Handle hazardous raw materials and cleaning solutions following all applicablesafety 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 KnowledgeMastered 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 with Supervisorsand colleagues.Adhere to written production records and validation protocols.Strong math and writing skills to document production activities in batchrecords and/or log books.Excellent attention to detail for documentation in production documents and tocompare produced goods against specified requirements.Capability to operate on a fast-paced manual assembly line using basicproduction equipment.Ability to legibly complete required documentation.CommunicationInteract with peers and members of other departments in team settings in aprofessional manner.Provide consistent coaching, guidance, development and mentorship tooperators.Education & ExperienceHigh school diploma or equivalent required.3 or more years of experience in a GMP manufacturing environment.Additional RequirementsAcceptable 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.Ability to lead by example and have a proven record of excellence inattendance, dependability and safety. Passing results on an internalinspection qualification for syringe inspection on semi-automated equipmentfor one syringe type.Core hours are Saturday - Tuesday 6:00am - 4:30pm