Cleanroom Fill Technicians (Multiple Shifts)

This job was posted by https://www.kansasworks.com : For more information, please see: https://www.kansasworks.com/jobs/13704500 Who We Are Since 1990, weve grown into a global leader in personalized medicine. Today, our +5,000 energetic employees are based in +80 locations in Europe, North America, South America, Africa and Asia-Pacific and are working together to support over 200,000 customers worldwide. From compounding and natural products to software, equipment, and genomics we deliver smart, ready-to-use solutions that make healthcare better. Were passionate, science-driven, and always looking for new ways to improve lives. ?? Explore your future atFagron Career Site. About The Job The Cleanroom Fill Technician will assemble finished sterile products with a focus on patient safety and quality; ensure that the clean room remains in a state of constant cleanliness and that supplies are appropriately stacked. Key Responsibilities - Maintains a sterile environment in the cleanroom, by garbing, cleaning the room, and behaving according to clean room procedures that align with CGMP practices or guidelines. - Cleans the equipment in the cleanroom daily; ensures equipment validations are up to date. - Follows the tech check tech process to oversee the techniques and practices of co-workers, including product assembly, measurements, garbing, sterile techniques, and documentation. - Take inventory into the cleanroom to identify components needed to fill production batches, as scheduled. - Ensure all components entering the clean room are sterile. - Coordinates and communicates with compounding and vial wash to obtain supplies needed to turn products; communicates within the clean room, from room to room. - Documents batch records, Climents (measurements of air in the room), lumacs (log use, maintenance, and cleaning of all equipment), and cleaning logs. - Prepares and sterilizes components/vials for appropriate solutions; sterilizes solutions and fills into specified containers. - Validates that garbing standards have been followed on a semi-annual basis. - Completes 3 consecutive media fills with a set minimum of syringes and vials that is established by the quality department in an established time frame and in the most difficult operating conditions to pass validation every 6 months. - Follows standard operation procedures to package sterile products in their final container closure. - Designate people and hoods for different tasks. - Use appropriate process to establish sterility on products received via pass through from compounding. - Clock in and out for every scheduled shift in a timely manner. Basic Qualifications - High school diploma or equivalent; one to four years previous work experience in a hospital or manufacturing environment or doing aseptic filling. - Knowledge of cleanroom procedures preferred but not required. - Knowledge of and compliance with CGMP (Current Good Manufacturing Practices) regulations preferred but not required. - Must pass validation three consecutive times before handling product in clean room; must be re-qualified every 6 months with a minimum requirement of filling a set minimum of syringes and vials in an established time frame and difficult operation conditions. Preferred but not required. - Ability to work with others in a positive and professional manner and to develop and maintain strong working relationships with co-workers and management. - Ability to take initiative, including asking for and offering help when needed; performs work independently without being prompted. - Strong attention to detail and focus on quality, accuracy, sterility, and aseptic technique. - Ability to prioritiz and plan work activities. Manages time effectively and adapts quickly to changing priorities. - Ability to handle multiple tasks and organize resources to ensure work is completed on time. Working Conditions - This position requires standing, walking, and bending for extended periods of time. - Employees must wear specialized protective clothingcommonly referred to as gowning or garbto minimize the risk of contamination. - Pushing and pulling carts loaded with totes of product. - The employee must occasionally lift and/or move totes of product weighing over 40 pounds. Team lifting is strongly encouraged. - The employee will be required to read small print. - Regular exposure to strong chemical odors and fumes. - Work may be performed in confined or tight spaces. - Moderate to high noise levels from machinery and surrounding personnel. - Use of appropriate personal protective equipment (PPE) is required. What\'s on Offer? Fagron offers its associates competitive salaries and a wide range of benefits including a 401(k) plan with a company matching contribution; medical, vision and dental; health savings accou