Aseptic Filling Specialist

1 week ago


Wichita, Kansas, United States Fagron Sterile Services Full time
Position Overview

The Aseptic Filling Specialist is responsible for the meticulous assembly of sterile products, prioritizing patient safety and product quality. This role ensures the cleanroom is consistently maintained in a pristine state, with supplies organized effectively.

Key Responsibilities:
  • Uphold a sterile environment within the cleanroom by adhering to proper garbing, cleaning protocols, and cleanroom procedures that comply with CGMP standards.
  • Conduct daily cleaning of equipment in the cleanroom, ensuring all equipment validations are current.
  • Implement the 'tech check tech' protocol to supervise the practices of colleagues, covering aspects such as product assembly, measurements, garbing, sterile techniques, and documentation.
  • Manage inventory within the cleanroom to identify necessary components for scheduled production batches.
  • Verify that all components entering the cleanroom are sterile.
  • Facilitate communication with compounding and vial wash teams to procure necessary supplies for product preparation.
  • Maintain accurate documentation of batch records, air quality measurements, equipment maintenance logs, and cleaning records.
  • Prepare and sterilize components and vials for various solutions, ensuring proper sterilization before filling into designated containers.
  • Conduct semi-annual validations to confirm adherence to garbing standards.
  • Successfully complete three consecutive media fills with a minimum quantity of syringes and vials as established by the quality department under challenging conditions every six months.
  • Follow standard operating procedures for packaging sterile products into their final container closures.
  • Assign specific tasks and designate hoods for various operations.
  • Utilize appropriate processes to establish sterility for products received through compounding.
  • Record attendance accurately by clocking in and out for each scheduled shift.
Qualifications:
  • High school diploma or equivalent; one to four years of relevant experience in a healthcare or manufacturing setting, particularly in aseptic filling.
  • Familiarity with cleanroom protocols is preferred but not mandatory.
  • Understanding of CGMP regulations is advantageous but not essential.
  • Must pass validation three consecutive times before engaging with products in the cleanroom; re-qualification is required every six months with specific filling targets.
  • Demonstrated ability to collaborate positively and professionally with colleagues and management.
  • Proactive approach to work, including seeking assistance and offering help as needed; capable of working independently.
  • Strong attention to detail with a focus on quality, accuracy, sterility, and aseptic techniques.
  • Effective time management skills, with the ability to prioritize tasks and adapt to changing demands.
  • Capability to manage multiple tasks and organize resources to ensure timely completion of work.
What We Offer:

Fagron Sterile Services provides a dynamic work environment where talent and ambition can flourish. Our culture is open and informal, encouraging individuals to be self-motivated and work independently. As a rapidly growing international pharmaceutical company, we offer competitive salaries, comprehensive benefits, and opportunities for professional development within an expanding industry.

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