TOLMAR Inc. Manufacturing Specialty Injectable Bulking Operator in Windsor, Colorado

Purpose and ScopeThe Specialty Injectable Bulk Operator leads manufacturing processes forspecialty injectable bulk products while ensuring those products are made withquality for our patients.Key Responsibilities Responsible for the multi-day processing of sterile and specialtyinjectable bulk products. Perform job tasks and responsibilities in accordance with standardoperating procedures (SOPs) and production records with an expectation of"Right the First Time". Assemble, setup, and operate advanced pharmaceutical manufacturingequipment including homogenizers, isolator glove boxes, wet mills,recirculating chillers, tangential flow filtration equipment, pumps,mixers, and CIP/SIP equipment. Accurately record data and required documentation in production records,standard operating procedure forms, and equipment/room log books andcalculate and evaluate results to support process. Perform equipment steam in place (SIP) on equipment used for sterilebulking processes. Preparation and formulation of bulk solutions and suspensions. Sterile filtration of intermediate and finished bulk solutions for furtherprocessing. Responsible for bulk equipment cleaning and verification of cleaningthrough swab and rinse sampling as necessary. Responsible for maintaining specialty injectable clean room environmentthrough area cleaning, disinfection, decontamination, and environmentalmonitoring. Responsible for deactivation and proper handling as well as disposal ofhazardous active pharmaceutical ingredients, raw materials, and/orcleaning materials as necessary following applicable safety procedures. Monitor critical process parameters and execute in-process sampling andtesting to ensure product quality throughout the bulking process. Evaluate in-process data and ensure timely reporting of data. Perform sampling and coordinate delivery of in process samples thatrequire testing in the Microbiology and QC Laboratories. Monitor and track in process and sterile hold times throughout the bulkprocess to ensure time limits are met. Review and maintain log books, production records, and forms to ensurecompliance with Tolmar procedures, regulatory requirements, and cGMPs. Complete periodic revision of procedures, forms, and productionrecords necessary for process improvement and/or routine documentationreview cycles. Provide training, guidance, and leadership to Aseptic ManufacturingOperators assisting with specialty injectable bulking processes. Provide support to Production Maintenance with troubleshooting andmaintaining of equipment utilized in the manufacture of specialty injectablebulking products. Monitor and review calibration and preventive maintenance of equipment toensure equipment is maintained properly and ready for use. Perform job tasks in a clean room environment requiring clean roomgowning, 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 PPEo High Temperature Steam/Water PPE Perform final review of processes and associated documentation atconclusion of major processing steps or completion of the batch to ensurequality of documentation and product. Properly perform job duties as a second checker, ensuring all productionactivities are correctly performed on batch records in accordance with cGMPstandards. Operate under the guidance of the Aseptic Operations Supervisor. Perform other duties as assigned.Special Skills and Knowledge Mastered knowledge of current Good Manufacturing Procedures (cGMP) asthey relate to sterile injectable manufacturing. Proficient in Microsoft Office (Excel, Word, and Outlook). Ability to maintain focus on detail-oriented and highly technical tasks. Ability to follow, understand, and revise standard operatingprocedures and production records. Strong math, writing, and technical skills. Strong attention to detail. Full understandin