Compounding Manager Jobs (NOW HIRING)

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.