Sterile Compounding Technician (USP & Focus)

Sterile Compounding Technician (USP <797> & <800> Focus)

Our Pharmacy's sterile compounding cleanroom is designed to meet and exceed USP <797> and <800> requirements. We prepare injectables, irrigations, and hazardous sterile compounds with absolute precision. We are seeking a disciplined, technique-driven sterile compounding technician who treats every preparation as a personal responsibility to the patient.

The Sterile Compounding Technician prepares high-risk sterile preparations, including hazardous drugs, within our ISO-classified cleanroom suite. You will embody flawless aseptic technique, rigorous garbing and hand hygiene protocols, and unwavering adherence to environmental control practices. This role is central to ensuring the sterility, potency, and safety of every sterile dose leaving our pharmacy.

Key Responsibilities

Aseptic Compounding (USP <797>)

• Compound sterile preparations from non-sterile-to-sterile components inside ISO Class 5 Primary Engineering Controls (LAFW or BSC), executing proper aseptic manipulations.
• Verify and affix BUDs as assigned by the PIC based on risk level and ISO class, and perform final visual inspection (absence of particulate matter, integrity of closure).

Hazardous Sterile Compounding (USP <800>)

• Compound sterile hazardous drugs inside a certified Biological Safety Cabinet (Class II Type B2 or externally vented A2) placed in a negative-pressure ISO Class 7 buffer room with an ISO Class 7 ante-room.
• Don full HD PPE: chemotherapy-tested impermeable gown, two pairs of chemo gloves (inner under cuff, outer over cuff), eye/face shield, and respiratory protection if spill/aerosolization risk.
• Utilize closed-system transfer devices (CSTDs) for preparation and administration whenever possible, adhering to manufacturer's directions.
• Perform thorough deactivation, decontamination, and cleaning of the BSC work surface and side walls after each use.

Cleanroom & Environmental Integrity

• Execute daily, shift, and post-compounding cleaning of all ISO-classified areas using sporicidal and bactericidal agents in the correct sequence.
• Participate in environmental monitoring tasks (viable air sampling, nonviable particle counting, surface sampling) as directed by the PIC.
• Successfully complete semi-annual media-fill testing of low- and high-risk processes, simulating worst-case conditions, with a passing result (no growth).

Garbing & Personnel Hygiene

• Perform surgical hand scrub and don sterile gloves via closed-assisted or solo technique without contamination; wear full aseptic garbing in the correct order.
• Complete gloved fingertip sampling as scheduled and undergo semi-annual re-certification of garbing competency and aseptic technique.
• Refrain from makeup, jewelry, nail polish, or artificial nails; immediately report any health condition that could compromise sterility.

Documentation & Supply Management

• Fill out sterile compounding logs completely, recording PEC used, fill volume, sterility filter lot, and visual inspection results.
• Inspect all sterile components before use for cracks, leaks, or compromised packaging; quarantine questionable items.
• Manage cleanroom inventory of sterile supplies, alcohol, sporicides, mops, and wipes, ensuring all meet cleanroom-grade specifications.

Qualifications

• Required:
• High school diploma or equivalent; PTCB or NHA certification preferred.
• Active Pharmacy Technician license/registration in Nevada.
• Minimum 1-2 years of experience in sterile compounding within a USP <797>-compliant cleanroom, including hazardous drug compounding per USP <800> .
• Documented competency in aseptic technique, including media-fill tests and gloved fingertip sampling.
• Thorough understanding of cleanroom garbing, hand hygiene, and airflow principles.
• Ability to pass a respirator fit test and medical clearance for cleanroom work.
• Preferred:
• Experience with CSTDs and biological safety cabinets.
• Familiarity with environmental monitoring equipment and procedures.
• Certification in sterile compounding (e.g., PTCB Sterile Compounding Certificate or equivalent).

This role is performed entirely within an ISO-classified cleanroom suite requiring full aseptic garbing, including hood, mask, sterile gown, and multiple gloves. Shift-long standing, fine motor manipulation, and concentration are required. You must be free of conditions that could compromise the sterile field. The environment may involve exposure to hazardous drugs with stringent safety controls in place. A pre-employment respirator fit test and medical evaluation are mandatory.

We offer a competitive hourly rate and a full benefits package (medical, dental, vision, 401(k) with match, paid time off). We invest in your ongoing training and recertification, ensuring you remain at the forefront of sterile compounding practice.