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

Purpose and ScopeThe Derms Lead Operator supervises and leads processes including set-up andoperation of processes related to supporting the dermatology 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 Coverso Hairnets (and beard covers as applicable)o Tyvek Coverallso Gloveso Full-face masks/hoodso Goggleso Full Face-Respirator or PAPR (Powered Air Purifying Respirator) Properly perform job duties as a second-checker ensuring all productionactivities are correctly performed per batch production records. Set up, operate and verify semi-automatic filling equipment used tofill dermatological products. Operate fast-paced, basic production equipment with manual loadingprocesses. Perform routine sampling and inspections for product attributes (fillweights, product sealing, labeling) of filled products. Perform set up and operation of semi-automatic labeling equipment usedto apply labeling to pre-filled jars, bottles and vials. Perform biological sampling of general manufacturing cleanroom facilities. Document production activities using regulatory controlled documentsincluding production records and log books. Perform facility cleaning of manufacturing areas as required to maintaina cGMP environment and by TOLMAR Standard Operating Procedures. Responsible for assembly, disassembly and sanitation of various equipment. Ensure that the quality of product being produced on assigned productionline meets specified standards. Train other Manufacturing Operators and Manufacturing Technicians in theDermatology Products team to perform job duties related to their position. Operate under the consistent supervision of Manufacturing Supervisor -Derms. Perform final review of processes before the processes can be consideredcomplete. Coordinate the daily tasks for Manufacturing Operators and technicianswithin assigned process. Coordinate materials, staffing and resources to support line operationand 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. Perform other duties as assigned.Special Skills and Knowledge Mastered knowledge of current Good Manufacturing Procedures (cGMP)as they 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, Outlook). Ability to maintain focus on detail-oriented, repetitive tasks. Excellent verbal and written communication skills. Ability to adhere to written production records and validation protocols. Strong understanding of basic math and writing skills to documentproduction activities in batch 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. Excellent attention to detail for documentation in production documentsand to compare produced goods against specified requirements. Technical ability to assemble and disassemble filling equipment.Core Values The Lead Operator - Derms is expected to operate within the framework ofTolmar 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 c

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