Over de functie
The Hazardous Drug (HD) Aseptic Technician will assemble finished sterile products with a focus on patient safety and quality. These tasks include compounding and aseptic filling of hormone and chemotherapy products in an aseptic environment.
Responsibilities:
• Responsible for the manufacturing of potent and hazard drugs.
• Must qualify for respirator and aseptic gowning.
• Works with hormone and chemotherapy products.
• 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 clean room daily; ensures equipment validations are up to date.
• Performs necessary environmental monitoring sampling.
• Takes inventory in the clean room to identify components needed to fill production batches, as scheduled.
• Ensures 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.
• Documents batch records, lumacs (log use, maintenance, and cleaning of all equipment), and cleaning logs.
• Completes media fills with a set minimum of syringes and vials that is established by the quality department within a defined time frame.
• Follows standard operation procedures to package sterile products in their final container closure.
• Clock in and out for every scheduled shift in a timely manner.
Maak het verschil
Experiences
• High school diploma or equivalent; one to four years previous work experience in a hospital or manufacturing environment or doing aseptic filling.
• Knowledge of clean room procedures, preferred.
• Knowledge of and compliance with CGMP (Current Good Manufacturing Practices) regulations, preferred but not required.
• Ability to work with others in a positive and professional manger and to develop and maintain strong working relationship 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 prioritize 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.
Wat bieden wij?
We offer a dynamic environment where talent and ambition can develop to its fullest. We have an open and informal organization culture, where individuals need to have strong motivation and ability to work independently. Fagron is a widely expanding, international, professional, and ambitious pharmaceutical company with multiple growth opportunities. Job opportunity includes competitive salary, comprehensive benefits, performance package, and ability to be part of an international leader in an expanding industry.