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Description
Job Summary
The Certified Sterile Compounding Technician is responsible for preparing sterile compounded medications under the direct supervision of a Sterile Compounding Manager at Greenwich Rx. This role executes sterile compounding activities with a high degree of independent technical proficiency, applying rigorous aseptic technique, cleanroom discipline, and meticulous documentation to every preparation, every shift, without exception.
Operating in compliance with all applicable federal and Texas state laws, Texas State Board of Pharmacy (TSBP) requirements, and United States Pharmacopeia (USP) standards; including USP <797> (sterile compounding) and USP <800> (hazardous drug handling), the Certified Sterile Compounding Technician maintains ISO-classified environment integrity, produces accurate and complete compounding records, supports environmental monitoring and inspection readiness, and meets daily production and turnaround time expectations while protecting patient safety and product integrity at every stage.
With a minimum of 1 year of sterile compounding experience required, this role is expected to compound with high independence within scope, serve as a disciplined and reliable presence on the cleanroom floor, and actively contribute to the quality and compliance culture that Greenwich Rx's patients and regulators depend on.
Professional Scope & Role Boundaries
The Certified Sterile Compounding Technician is authorized to prepare sterile compounded preparations and perform associated cleanroom, documentation, cleaning, and inventory tasks only to the extent permitted by Texas law, TSBP regulations, and Greenwich Rx policies, and exclusively under direct pharmacist supervision. This role does not perform pharmacist-only duties, including final product verification, clinical decision-making, patient counseling, or product release.
Any deviation from SOP, suspected contamination event, environmental excursion, hazardous drug exposure concern, equipment malfunction, controlled substance discrepancy, or patient-impacting concern must be escalated immediately to the supervising pharmacist and/or the PIC without exception. The Certified Sterile Compounding Technician must follow all SOPs, quality controls, and documentation requirements precisely and without deviation; there is no gray area in sterile compounding.
Key Responsibilities
Sterile Compounding Execution - Aseptic Technique
- Prepare sterile compounded preparations under pharmacist supervision using validated aseptic technique, established SOPs, and approved compounding records; including injections, infusions, ophthalmics, and other sterile dosage forms as assigned.
- Perform sterile transfers, withdrawals, and manipulations using appropriate devices, syringes, needles, filters, transfer sets, and closed-system transfer devices (CSTDs) as required, in strict accordance with SOP and cleanroom discipline requirements.
- Execute accurate measurements, volume calculations, and verification steps within technician scope, completing all required independent and double-check steps as assigned per SOP before routing for pharmacist review.
- Support sterile batch preparation processes; maintaining accurate workflow sequencing, lot segregation, and labeling integrity throughout the batch to prevent product mix-ups and ensure full traceability.
- Perform visual inspections within technician scope; including particulate inspection and container integrity checks — and immediately escalate any quality concern to the supervising pharmacist before the preparation advances.
USP <797> Environmental Control & Cleanroom Discipline
- Maintain strict compliance with all garbing, gloving, and cleanroom entry procedures per USP <797> and Greenwich Rx SOP requirements; no exceptions, including donning sequence, hand hygiene, and behavior upon re-entry.
- Maintain ISO-classified work area discipline throughout every shift, including correct material flow, appropriate movement patterns, airflow awareness, and contamination prevention behaviors within the primary and secondary engineering controls (PEC/SEC).
- Maintain aseptic technique throughout all compounding activities; including first air protection, proper hood practices, surface discipline, and critical site awareness; without compromise regardless of production pace or volume.
- Contribute to cleanroom environmental requirements by maintaining orderly, organized workspaces, supporting correct disinfection intervals, and preventing cross-contamination between sterile and non-sterile areas at all times.
USP <800> & Hazardous Drug (HD) Handling
- Perform hazardous drug sterile compounding tasks when assigned, applying correct PPE selection, donning sequence, garbing, and containment practices per USP <800> and Greenwich Rx HD SOPs always without exception.
- Follow all hazardous drug storage, staging, and material flow requirements, including correct use of CSTDs, ventilated cabinets, and designated HD compounding areas to prevent contamination and exposure to personnel and the environment.
- Support hazardous drug spill response within trained scope immediately and escalate all incidents, exposures, and near misses to the supervising pharmacist and safety officer per policy; no spill or exposure event is too minor to report.
- Maintain strict segregation, decontamination, and waste disposal practices for all hazardous drug materials in accordance with USP <800>, TSBP regulations, EPA requirements, and Greenwich Rx SOPs.
Documentation, Batch Records & Traceability
- Complete all compounding records accurately and in real time, including ingredient names, lot numbers, expiration dates, quantities, calculated volumes, verification steps, and technician initials, for every preparation without exception.
- Maintain all assigned logs accurately and on schedule equipment use logs, temperature and humidity logs, cleaning and disinfection logs, and environmental monitoring support documentation; ensuring no gaps, no late entries, and no incomplete records.
- Verify that labels match preparation records and route all products with complete, organized documentation for pharmacist verification in accordance with SOP sequencing and timing requirements.
- Report all documentation discrepancies, missing data, calculation questions, or required corrections immediately to the supervising pharmacist and document per the deviation and correction SOP; never alter or correct records without pharmacist authorization.
Cleaning, Disinfection & Environmental Monitoring Support
- Perform all routine and scheduled cleaning and disinfection of primary engineering controls (LAFWs, BSCs, CACIs), work surfaces, pass-throughs, ante-areas, and designated cleanroom zones per SOP using correct agents, concentrations, contact times, and rotation schedules.
- Support environmental monitoring processes as assigned; including surface sample collection support, settle plate placement, and air sampling support; ensuring all required monitoring documentation is completed accurately and on time.
- Maintain continuous inspection readiness by ensuring all cleaning tasks, schedules, and logs are completed correctly and on time; the cleanroom must be audit-ready at all times, not only during scheduled reviews.
Sterile Inventory, Staging & Supply Readiness
- Stage sterile supplies and compounding materials in accordance with cleanroom material flow requirements, ISO classification zones, and HD segregation protocols; ensuring no non-sterile, expired, or unreleased materials are introduced to the compounding area.
- Monitor sterile supply levels throughout each shift; including syringes, needles, disinfectants, sterile containers, CSTDs, and sterile consumables, and communicate replenishment needs to leadership before a shortage can impact production.
- Apply FEFO (first expired, first out) and FIFO inventory practices consistently; verify expiration dates, lot numbers, and release status on all materials before use; and quarantine or hold any suspect inventory per SOP pending pharmacist disposition.
Equipment Readiness & Escalation
- Perform assigned equipment readiness tasks within training scope, including routine checks, analytical balance verifications, laminar airflow checks, and log verifications before beginning compounding each shift.
- Escalate all equipment malfunctions, maintenance needs, temperature or pressure excursions, and environmental alarms to the supervising pharmacist immediately; never continue compounding on equipment that has not been confirmed in specification.
- Support troubleshooting by providing clear, complete, and timely documentation of the issue; including what was observed, when it was observed, and any associated preparation or batch information to the supervising pharmacist and leadership.
Team Communication, Compliance & Continuous Improvement
- Collaborate effectively with pharmacists, compounding technicians, and operations teams to meet daily production schedules, turnaround time targets, and patient service commitments.
- Communicate workload barriers, SOP deviations, safety concerns, or quality issues promptly to the supervising pharmacist; no concern is too small to raise, and silence is never the appropriate response to a potential quality or safety event.
- Participate actively in CAPA activities, deviation reviews, and continuous improvement initiatives; contributing observations, root cause input, and SOP improvement suggestions as requested.
- Support cross-training and mentoring of less experienced technicians in cleanroom discipline, aseptic technique, and documentation standards as directed by the supervising pharmacist.
Scheduling & Availability
- Maintain availability consistent with pharmacy production needs, which may include days, evenings, weekends, and holidays as required by operational schedules.
- All hours are compensated in full accordance with applicable wage and hour laws as a non-exempt employee.
Qualifications & Competencies
Required
- High school diploma or GED required
- Active Certified Pharmacy Technician (CPhT) certification; required at time of hire
- Active registration as a Pharmacy Technician in good standing with the Texas State Board of Pharmacy (TSBP), with CPhT status as required by TSBP
- Sterile compounding qualification required: trained, validated, and authorized as a sterile compounder per Greenwich Rx sterile training program and applicable USP <797>/TSBP requirements; including successful completion of all required aseptic technique competency assessments (media fill and gloved fingertip testing)
- Minimum of 1 year of sterile compounding experience in a hospital, infusion center, 503A/503B facility, or dedicated sterile compounding lab environment
- USP <800> hazardous drug handling experience required; must be trained and competent in HD PPE, containment, spill response, and waste disposal
- Demonstrated ability to maintain cleanroom discipline, follow SOPs without deviation, and produce accurate and complete compounding documentation under pressure
- Ability to maintain required ongoing competencies including media fill and gloved fingertip testing, and to comply fully with revalidation and retraining schedules
- Strict HIPAA compliance and confidentiality; ability to handle all patient information with absolute discretion
Preferred
- 2+ years of sterile compounding experience working in ISO-classified cleanrooms (ISO 5, 7, and/or 8) in a 503A or 503B compounding pharmacy environment
- Experience supporting environmental monitoring documentation, excursion investigation, and inspection readiness activities
- Experience with compounding documentation systems, label verification workflows, and production tracking software
Informal lead, trainer, or mentoring experience for less experienced technicians in cleanroom and aseptic technique standards
Key Competencies
- Aseptic technique discipline, correct, consistent, and uncompromising execution every preparation
- Safety-first behavior and hazardous drug handling awareness, zero shortcuts on PPE or containment
- Documentation accuracy and integrity, real-time, complete, and traceable records without exception
- Compliance mindset, ability to follow SOPs precisely and escalate deviations without hesitation
- Production efficiency, meeting throughput and turnaround targets without compromising technique or quality
- Professional communication and cross-functional teamwork
- Calm, deliberate execution in high-accountability, high-stakes environments
Physical & Work Environment Requirements
- Onsite work required at all times, remote work is not available for this role
- Ability to stand for extended periods throughout each shift in a controlled cleanroom environment
- Frequent repetitive use of arms, hands, and fingers for precise sterile manipulation tasks
- Ability to bend, reach, push, pull, and lift 30 pounds or more
- Ability to wear required PPE throughout the shift; including full cleanroom garb (gown, gloves, hood, shoe covers, face mask) and, when applicable,
- additional PPE required for hazardous drug compounding
- Ability to work in ISO-classified controlled environments under strict behavioral, movement, and garbing requirements without accommodation
Success Profile
A successful Certified Sterile Compounding Technician at Greenwich Rx will:
- Execute sterile preparations with consistent, validated aseptic technique, every preparation, every shift, without exception
- Maintain cleanroom discipline and USP <797>/<800> compliance as a non-negotiable standard, not a variable based on production volume
- Complete every compounding record in real time, accurately, and completely, never from memory, never after the fact
- Catch quality concerns before they become patient safety events and escalate immediately without hesitation
- Treat every hazardous drug interaction with the containment discipline that protects both patients and colleagues
- Maintain inspection readiness every shift, not just when an audit is scheduled
- Contribute to a culture of continuous improvement, safety reporting, and professional accountability
Value Proposition
Sterile compounding is one of the most technically demanding, regulated, and patient-safety-critical functions in all of pharmacy operations. A single contamination event, a single aseptic technique failure, or a single documentation gap in a sterile preparation can have direct, irreversible consequences for the patient receiving that medication. The Certified Sterile Compounding Technician is the primary technical line of defense against those outcomes.
This role is ideal for a CPhT-certified, experienced sterile compounding professional who approaches cleanroom work with the precision of a scientist, the discipline of a compliance officer, and the commitment of someone who understands that their technique directly determines whether a vulnerable patient receives a safe, effective medication or doesn't.
Equal Employment Opportunity
Greenwich Rx is an Equal Opportunity Employer. We are committed to creating an inclusive workplace and do not discriminate based on race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, genetic information, or any other protected status under applicable law. Employment is contingent upon successful completion of applicable background checks and employment eligibility verification.