Compounding Pharmacist
Remedy · Houston, TX · 3 wk ago
On-siteHealthcare$133k–$137k/yrFull-time
About the role
As a Compounding Pharmacist you will provide final verification and clinical oversight of compounded sterile and non‑sterile preparations, ensuring each preparation meets standards for identity, strength, quality, and purity. You will also own the quality systems that make compounding defensible, including formulation records, competency assessment, deviation investigation, and regulatory compliance under USP , , and applicable state and federal law.
Responsibilities
- Verification & Clinical Oversight
- Perform final verification of all CSPs and non‑sterile preparations (ingredient identity, calculations, technique observation, labeling, physical inspection).
- Review and approve compounding records prior to release.
- Conduct prospective review of prescriptions for appropriateness, dose, route, compatibility, stability, and drug interactions.
- Confirm patient‑specific prescriptions are valid and that compounding is permitted for the drug and dosage form.
- Serve as the clinical resource for prescribers and patients on formulation, stability, storage, and administration.
- Formulation & Quality Systems
- Develop, review, and approve master formulation records with documented, defensible stability and beyond‑use dating rationale.
- Establish BUDs based on published stability data, USP defaults, or facility‑specific stability studies.
- Coordinate sterility, endotoxin, potency, and container‑closure integrity testing; review and act on results.
- Investigate deviations, OOS results, complaints, and adverse events; document root cause and CAPA.
- Author and maintain SOPs; ensure revisions are controlled, trained, and effective‑dated.
- Compliance & Facility Oversight
- Support or serve as the Designated Person under USP /, as assigned.
- Oversee environmental monitoring programs and trend results; escalate excursions.
- Verify equipment certification, calibration, and PEC/SEC recertification schedules.
- Maintain hazardous drug risk assessments and associated controls.
- Prepare for and support Board of Pharmacy, FDA, and accreditation inspections.
- Ensure compliance with DQSA Section 503A/503B requirements, including prescription‑based dispensing and cGMP obligations.
Requirements
- Active pharmacist license in Texas, in good standing; eligible for licensure in additional states as required.
- 5+ years of pharmacy practice with demonstrable sterile compounding experience.
- Documented aseptic technique training and current qualification.
- Board certification (BCSCP) or equivalent.
- Thorough working knowledge of USP , , .
- Sound judgment and willingness to hold a release when documentation or quality is in question.
- Physical ability to stand for periods, work in a cleanroom in full garb, and lift up to 25 lb.
Preferred qualifications (bonus points)
- Experience as a Designated Person, PIC, or in a QA/QC role at a compounding facility.
- cGMP experience in an FDA‑registered 503B outsourcing facility.
- Experience scaling compounding operations, validating new formulations, or supporting facility build‑out.
- Multi‑state licensure.
Benefits
- Robust and affordable medical, dental, and vision plan options.
- Flexible time‑off policy.
- Annual incentive plan.
- Stock options (where applicable).
- Full range of medical, financial, and other benefits dependent on the position offered.
Pay
Base pay range: $133,000 – $137,000 per year. Base pay may vary depending on job‑related knowledge, skills, and experience. An annual incentive plan and stock options may be provided as part of the compensation package.