Sterile Compounding Technician

Remedy • Houston, TX

15h

About The Position

As a Sterile Compounding Pharmacy Technician, you will prepare compounded sterile preparations (CSPs) under the direct supervision of a licensed pharmacist, in accordance with USP <797>, USP <800>, state Board of Pharmacy regulations, and facility standard operating procedures. The role is responsible for maintaining aseptic technique, accurate documentation, and cleanroom integrity throughout the compounding process.

The technician prepares CSPs and supports batch production, cleanroom operations, compliance, environmental monitoring, documentation, and inventory management. The role includes handling hazardous drugs with appropriate controls and supporting audits, inspections, and recall activities.

Requirements

• PTCB Certified Pharmacy Technician (CPhT) certification.
• Certified Compounded Sterile Preparation Technician (CSPT) certification.
• Active pharmacy technician license/registration in Texas, in good standing.
• 2 years of sterile compounding experience in a 503A, 503B, or hospital IV room setting.
• Demonstrated proficiency in aseptic technique with current media-fill and gloved fingertip qualification.
• Working knowledge of USP <795>, <797>, and <800>.
• Strong pharmaceutical calculation skills and attention to detail.
• Ability to follow written SOPs precisely without deviation.
• Ability to stand for extended periods and perform repetitive fine-motor work at a hood.
• Ability to lift up to 35 lbs.
• Ability to work in a controlled cleanroom environment requiring full garb, with no cosmetics, jewelry, or artificial nails.
• Exposure to hazardous drugs with appropriate engineering and PPE controls.
• Must pass fit-testing for respiratory protection where applicable.

Nice To Haves

• Experience with automated compounding devices, pump-fillers, or semi-automated filling equipment.
• Experience in an FDA-registered outsourcing facility under cGMP.
• Familiarity with pharmacy management systems and electronic batch records.

Responsibilities

• Prepare CSPs from master formulation records, including admixtures, syringes, vials, and batch preparations.
• Perform manipulations within an ISO Class 5 primary engineering control using validated aseptic technique.
• Calculate, measure, and reconcile ingredient quantities; verify NDCs, lot numbers, and expiration dates.
• Stage and label preparations for pharmacist verification and do not release a CSP without a documented final check.
• Assign beyond-use dates according to approved formulation records and applicable USP standards.
• Support batch production runs, including in-process checks and yield reconciliation.
• Complete garbing, hand hygiene, and gowning according to SOPs before entering classified areas.
• Maintain and document ongoing competency, including gloved fingertip/thumb sampling and media-fill validation at required intervals.
• Perform and log routine cleaning and disinfection of PECs, SECs, and ancillary surfaces.
• Support environmental monitoring, including viable and nonviable air sampling, surface sampling, and pressure differential and temperature/humidity logging.
• Handle hazardous drugs according to USP <800>, including appropriate PPE, closed-system transfer devices, and spill response.
• Promptly report deviations, near misses, and out-of-specification results.
• Complete compounding records, cleaning logs, and monitoring documentation legibly, contemporaneously, and completely.
• Maintain inventory of APIs, excipients, containers, closures, and consumables; rotate stock and monitor for expiry.
• Assist with recall response, quarantine of suspect materials, and destruction documentation.
• Support internal audits and regulatory inspections as directed.

Benefits

• Robust and affordable medical, dental, and vision plan options.
• Vacation time off policy, with up to 10 vacation days accrued in the first year; vacation begins accruing immediately.

What This Job Offers

• Job Type: Full-time
• Education Level: No Education Listed