Compounding Pharmacist

As a Compounding Pharmacist, you will provide final verification and clinical oversight of compounded sterile and non-sterile preparations, ensuring every preparation meets standards for identity, strength, quality, and purity. Beyond dispensing accuracy, you will own the quality systems that make compounding defensible: formulation records, competency assessment, deviation investigation, and regulatory compliance under USP <795>, <797>, <800>, and applicable state and federal law.

Verification & Clinical Oversight

Perform final verification of all CSPs and non-sterile preparations, including ingredient identity, calculations, technique observation, labeling, and physical inspectionReview and approve compounding records prior to releaseConduct prospective review of prescriptions for appropriateness, dose, route, compatibility, stability, and drug interactionsConfirm patient-specific prescriptions are valid and, where applicable, that compounding is permitted for the drug and dosage formServe as the clinical resource for prescribers and patients on formulation, stability, storage, and administration

Develop, review, and approve master formulation records with documented, defensible stability and beyond-use dating rationaleEstablish BUDs based on published stability data, USP defaults, or facility-specific stability studies — not assumptionCoordinate sterility, endotoxin, potency, and container-closure integrity testing; review and act on resultsInvestigate deviations, OOS results, complaints, and adverse events; document root cause and CAPAAuthor and maintain SOPs; ensure revisions are controlled, trained, and effective-dated

Support or serve as the Designated Person under USP <797>/<800>, as assignedOversee environmental monitoring programs and trend results; escalate excursionsVerify equipment certification, calibration, and PEC/SEC recertification schedulesMaintain the hazardous drug assessment of risk and associated controlsPrepare for and support Board of Pharmacy, FDA, and accreditation inspectionsEnsure compliance with DQSA Section 503A / 503B requirements, including prescription-based dispensing / cGMP obligations

Active pharmacist license in Texas, in good standing; eligible for licensure in additional states as required5+ years of pharmacy practice with demonstrable sterile compounding experienceDocumented aseptic technique training and current qualificationBoard certification (BCSCP) or equivalentThorough working knowledge of USP <795>, <797>, <800>, and <1163>Sound judgment and the willingness to hold a release when documentation or quality is in question

Experience as a Designated Person, PIC, or in a QA/QC role at a compounding facilitycGMP experience in an FDA-registered 503B outsourcing facilityExperience scaling compounding operations, validating new formulations, or supporting facility buildoutMulti-state licensure

Periods of standing; ability to work in a cleanroom in full garb as neededPotential exposure to hazardous drugs with appropriate controlsAbility to lift up to 25lbs

All Company policies and procedures are subject to change without notice based on business needs. This includes, but is not limited to, the locations where we hire remote, hybrid, or onsite employees.