Title: Aseptic Compounding Technician
Job Purpose:
Using company procedures and guidelines, the Aseptic Compounding Technician is responsible for preparing compounded sterile preparations according to batch record instructions. This shall include setting up and operating all compounding equipment, filling of medical device containers, equipment cleaning, and documentation of all related activities.
Key Accountabilities:
- Regular and predictable onsite attendance and punctuality
- Accurately and aseptically prepare compounded sterile preparations according to batch record instructions and per internal SOPs and cGMPs to ensure the quality and integrity of products
- Demonstrate appropriate cleanroom behavior and aseptic technique
- Set up and operate all compounding equipment safely and accurately according to policy and procedure
- Complete and maintain applicable logbook and batch record paperwork abiding by Good Documentation Practices (GDPs)
- Execute aseptic qualification and equipment qualification protocols as required
- Maintain aseptic qualification and gown qualification
- Collect environmental monitoring samples and perform other quality checks as necessary
- Escalate any and all process issues to the area supervisor or designee
- Perform and oversee thorough cleaning of the Clean Room areas per internal SOPs
- Provide peer training on all Clean Room procedures as necessary
- Organize Clean Room workflow
- Maintain good hygiene prior to coming into work each day
- Perform other related duties as determined by management personnel
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Dayton, NJ, US, 08810
Nearest Major Market: New Jersey