Sterile Compounding Technician

FT M-F 9AM-6PM
INTENDED START DATE: 8/1

Position Summary

The Sterile Compounding Technician at Stratum Pharmacy’s Dallas (Coppell) facility performs hands-on sterile

compounding activities within ISO-classified cleanroom environments under the supervision of a licensed

pharmacist. This role is responsible for the accurate preparation, labeling, and documentation of sterile

preparations in full compliance with USP <797>, USP <800>, TSBP Rule 291.133, and the Texas Pharmacy Act.

The Technician works collaboratively with the compounding team to maintain safe, inspection-ready operations

and consistent product quality.

Sterile Compounding Operations

• Prepare sterile compounds (IVs, injections, and other sterile dosage forms) using aseptic technique within

ISO 5 primary engineering controls (LAFWs, BSCs, CACIs, isolators) per master formulation records and

batch records.

• Perform calculations, measurements, and component selection accurately and in accordance with

pharmacist-verified formulation records.

• Label, package, and stage completed sterile preparations per USP <797> requirements and facility

SOPs, within pharmacist-approved BUD assignments.

• Operate and conduct routine maintenance checks on compounding equipment; report anomalies to the

supervising pharmacist or department manager immediately.

• Maintain cleanroom area cleanliness and orderliness throughout the shift; perform end-of-shift and

periodic cleaning tasks per SOP.

• Additional duties as assigned.

Regulatory Compliance & Quality

• Execute all compounding activities in strict accordance with USP <797> (2023 revision), USP <800>,

TSBP Rule 291.133, and Stratum Pharmacy quality standards.

• Accurately complete batch records, compounding logs, and all required QA documentation at the time of

compounding; maintain documentation in audit-ready condition.

• Participate in environmental monitoring (EM) activities including viable air sampling, surface sampling,

and pressure/temperature logging per the EM SOP and schedule.

• Complete all required personnel qualification activities on schedule: media fills, gloved fingertip testing

(GFT), aseptic technique assessments, and competency evaluations.

• Report deviations, errors, out-of-specification results, and environmental excursions to the supervising

pharmacist or department manager promptly and completely.

• Support preparation for and participation in TSBP inspections, accreditation audits (PCAB, ACHC), and

internal quality audits.

Hazardous Drug Handling

• Handle hazardous drugs (HDs) in compliance with USP <800>: receive, segregate, store, compound, and

dispose of HDs only in designated negative-pressure ISO 7 / C-PEC environments using prescribed PPE.

• Follow facility Hazardous Drug Management Program and HD Exposure Control Plan procedures at all

times.

• Participate in required HD training, medical monitoring, and PPE competency assessments per the

exposure control plan.

• Perform deactivation, decontamination, and decommissioning activities as directed by the supervising

pharmacist and per SOP.

Inventory & Supply Support

• Inspect incoming raw materials and supplies: verify against purchase orders, check COAs, confirm

labeling, and quarantine and report any discrepancies.

• Maintain accurate component and finished preparation inventory within the cleanroom; communicate low-

stock or supply concerns to the department manager.

• Properly store all components and preparations per manufacturer requirements, USP guidelines, and

facility policy.

Minimum Qualifications

Education

• High school diploma or equivalent required.
• Completion of an accredited pharmacy technician training program preferred.

Licensure & Certification

• Active Texas Pharmacy Technician Registration required.
• PTCB Certified Pharmacy Technician (CPhT) preferred; PTCB Certified Sterile Compounding Pharmacy

Technician (CSPT) strongly preferred or willingness to obtain within 12 months.

• Prior completion, through a single course, of a minimum of 40 hours (ACPE-approved) of instruction and

experience in sterile compounding as required by the Texas Board of Pharmacy.

Experience & Knowledge

• Minimum 1–2 years of sterile compounding experience in a 503A or 503B pharmacy environment

preferred; new graduates with qualifying coursework considered.

• Working knowledge of USP <797> (2023 revision) and USP <800> aseptic technique and compliance

requirements.

• Demonstrated aseptic compounding skills including proper gowning, garbing, hand hygiene, and ISO

cleanroom behavior.

• Strong attention to detail and accuracy in calculation, preparation, and documentation tasks.
• Proficiency with compounding software and electronic batch record systems preferred.

Preferred Qualifications

• Experience in a 503A compounding pharmacy with peptides, BHRT, topical pain management, or sterile

injectables.

• PCAB or ACHC accreditation environment experience.
• Familiarity with automated filling and stoppering equipment (e.g., NEST NST-2501).

Physical Requirements & Work Environment

• Ability to work in and regularly access ISO-classified cleanroom environments with full gowning as

required by USP <797>.

• Ability to stand, walk, and perform compounding and documentation tasks for extended periods.
• Ability to lift up to 30 lbs (equipment components, supply totes).
• Work environment: cleanroom areas (≤68°F / 20°C), general pharmacy, and administrative workspace.
• Must comply with all cleanroom gowning, hygiene, and cosmetic restrictions per USP <797> and facility

policy when accessing controlled areas.

Supervisory Structure & Oversight

The Sterile Compounding Technician operates under the direct supervision of a licensed pharmacist and the day-

to-day direction of the Sterile Compounding Department Manager. Per the Texas Pharmacy Act and TSBP

regulations, all compounding activities performed by technicians must occur within technician scope of practice

and under pharmacist supervision. The Pharmacist-in-Charge (PIC) retains ultimate authority and accountability

for all sterile compounding activities at the facility.

Acknowledgment & Signature

By signing below, the employee acknowledges receipt of this job description, confirms understanding of all

responsibilities and requirements, and agrees to comply with all applicable standards, regulations, and Stratum

Pharmacy policies.

Pay: $23.00 - $28.85 per hour

Application Question(s):

• Do you have experience working in a 503A compounding pharmacy, including compounding peptides, bioidentical hormone replacement therapy (BHRT), topical pain management formulations, or sterile injectables?
• Do you have working knowledge of USP <797> (2023 revision) and USP <800> standards, including aseptic technique and compliance requirements?
• Do you currently hold an active Texas Pharmacy Technician Registration?
• Do you have experience with PCAB accreditation standards or supporting compounding pharmacy inspections, audits, or accreditation processes?

Work Location: In person

Salary : $23 - $29