Sterile Processing Pharmacy Technician 503b

Job Description

Job Description

Job Summary:

A Sterile Processing Technician in a 503B outsourcing facility plays a critical role in maintaining the sterility and safety of compounded sterile preparations (CSPs). This position ensures all equipment, instruments, and work environments are properly cleaned, sterilized, and prepared for pharmaceutical production in compliance with federal and state regulations, including USP <797> , <800> , and FDA 503B standards

Job Activities and Responsibilities:

• Decontaminate, clean, and sterilize equipment and instruments using appropriate techniques (e.g., autoclaves, sterilizers, and chemical disinfectants).
• Perform regular maintenance and cleaning of sterilization equipment to ensure optimal functionality.
• Adhere to all FDA 503B outsourcing facility regulations and USP guidelines.
• Monitor and report biological indicator results from sterilization cycles.

• Document cleaning and sterilization activities accurately in compliance with Good Documentation Practices (GDP).
• Prepare and package sterile instruments, tools, and materials for use in aseptic compounding.
• Inspect instruments and equipment for cleanliness, functionality, and damage before and after sterilization.
• Maintain inventory of sterile supplies and report shortages to supervisors.
• Ensure proper storage of sterilized equipment and materials in designated areas.
• Follow aseptic techniques and gowning procedures in cleanroom environments.
• Assist in maintaining a cleanroom environment through proper cleaning and disinfection practices.
• Work closely with compounding technicians, pharmacists, and quality assurance personnel.
• Participate in training sessions and quality improvement initiatives to enhance skills and knowledge.
• Additional responsibilities as assigned by manager

Minimum qualifications:

• High school diploma or GED required.
• Previous experience in sterile processing or a healthcare setting is strongly preferred. Experience in a 503B facility or pharmacy compounding is a plus.
• Familiarity with USP <797> , <800> , and FDA 503B regulations.
• Attention to detail and ability to follow strict protocols.

• Proficiency in handling sterilization equipment and aseptic techniques.
• Strong organizational and communication skills.

• Ability to work quickly and accurately under time and volume constraints

Physical requirements:

• Ability to lift thirty (30) pounds. Moving, lifting, or carrying boxes.
• Ability to sit/stand for extended periods
• Fine motor skills
• Working in controlled environments such as cleanrooms and sterilization areas.

Revelation Pharma is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.