The Sterile Filling Technician is responsible for filling sterile medication utilizing aseptic technique. The Sterile Filling Technician is also responsible for managing product inventory and supplies and is expected to maintain a highly organized clean room. The Sterile Filling Technician will work with Quality Assurance personnel to ensure compliance to standard operating procedures and regulatory requirements.
Responsibilities:
Fills compounded sterile products using aseptic technique.
Performs general cleaning and maintenance duties as directed.
Participates in cleanroom product preparation prior to sterile filling.
Complete filling process and documentation of process.
Maintains manufacturing records and completes all required documentation in compliance with cGMP, FDA, USP and pharmacy state board regulatory guidelines.
Operate and monitor technical, computerized compounding / filling equipment ensuring quality standards are maintained.
Prepares records and monitors results for pharmaceutical quality assurance testing.
Assists with other duties as required.
Qualifications:
Active SC State Pharmacy Technician Registration with State or National certification preferred
Minimum 2 years of prior Sterile Compounding Experience
Knowledge of IV products and compounding procedures preferred
General knowledge of proper cGMP aseptic gowning procedure and technique preferred
Familiarity with, and the ability to follow established Standard Operating Procedures (SOP), Master Batch Records, and adhere to cGMP
General knowledge of USP 797 and/or cGMP aseptic processing
Strong attention to detail, good math skills, and knowledge of Metric System
Must be able to spend a majority of time standing
Must be able to work well both individually and on a team
Must be able to lift, push, pull and carry up to 40+ pounds
Must be able to operate in full gowning protocol without skin exposure
