This job was posted by https://www.kansasworks.com : For more information, please see: https://www.kansasworks.com/jobs/13654139
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.]{contrast="auto"}
[Key Responsibilities]{contrast="auto"}
- [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.]{contrast="auto"}
- [Cleans the equipment in the cleanroom daily; ensures equipment validations are up to date.]{contrast="auto"}
- [Follows the tech check tech process to oversee the techniques and practices of co-workers, including product assembly, measurements, garbing, sterile techniques, and documentation.]{contrast="auto"}
- [Take inventory into the cleanroom to identify components needed to fill production batches, as scheduled.]{contrast="auto"}
- [Ensure all components entering the clean room are sterile.]{contrast="auto"}
- [Coordinates and communicates with compounding and vial wash to obtain supplies needed to turn products; communicates within the clean room, from room to room.]{contrast="auto"}
- [Documents batch records, Climents (measurements of air in the room), lumacs (log use, maintenance, and cleaning of all equipment), and cleaning logs.]{contrast="auto"}
- [Prepares and sterilizes components/vials for appropriate solutions; sterilizes solutions and fills into specified containers.]{contrast="auto"}
- [Validates that garbing standards have been followed on a semi-annual basis.]{contrast="auto"}
- [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.]{contrast="auto"}
- [Follows standard operation procedures to package sterile products in their final container closure.]{contrast="auto"}
- [Designate people and hoods for different tasks.]{contrast="auto"}
- [Use appropriate process to establish sterility on products received via pass through from compounding.]{contrast="auto"}
- [Clock in and out for every scheduled shift in a timely manner.]{contrast="auto"}
Basic Qualifications
[High school diploma or equivalent; one to four years previous work experience in a hospital or manufacturing environment or doing aseptic filling.]{contrast="auto"}
[Knowledge of cleanroom procedures preferred but not required.]{contrast="auto"}
[Knowledge of and compliance with CGMP (Current Good Manufacturing Practices) regulations preferred but not required.]{contrast="auto"}
[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.]{contrast="auto"}
[Ability to work with others in a positive and professional manner and to develop and maintain strong working relationships with co-workers and management.]{contrast="auto"}
[Ability to take initiative, including asking for and offering help when needed; performs work independently without being prompted.]{contrast="auto"}
[Strong attention to detail and focus on quality, accuracy, sterility, and aseptic technique.]{contrast="auto"}
[Ability to prioritize and plan work activities. Manages time effectively and adapts quickly to changing priorities.]{contrast="auto"}
[Ability to handle multiple tasks and organize re ]{contrast="auto"}