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Sterile Products Assembler
2 months ago
About the Role
The Aseptic Fill Technician will assemble finished sterile products with a focus on patient safety and quality; ensures 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 clean room 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.
- 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, 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.
- Uses appropriate process to establish sterility on products received via pass through from compounding.
- Clocks in and out for every scheduled shift in a timely manner.
Requirements
- 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 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.
- 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 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.
What We Offer
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.
