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About the Role

This role is responsible for overseeing all aspects of sterile compounding operations, ensuring patient safety, product quality, and regulatory compliance. It involves pharmacist verification, formulation review, batch release, quality assurance, environmental monitoring, personnel training, and compliance with USP <797>, state, and federal regulations. The position offers a unique opportunity to design workflows, validate processes, implement quality systems, and build a best-in-class sterile compounding laboratory from the ground up.

Responsibilities

Verify and approve sterile compounded prescriptions for accuracy, safety, and clinical appropriateness.
Supervise sterile compounding activities performed by pharmacy technicians.
Perform sterile compounding using USP <797> compliant aseptic technique.
Compound sterile preparations from raw active pharmaceutical ingredients (APIs).
Review formulations, calculations, compatibility, stability, and beyond-use dating.
Verify batch records and approve final product release.
Participate in sterile batch preparation and manufacturing.
Perform and oversee process validation activities.
Ensure compliance with USP <797>, state board of pharmacy regulations, and applicable FDA guidance.
Maintain accurate compounding documentation and quality records.
Develop, implement, and maintain sterile compounding standard operating procedures (SOPs).
Oversee environmental monitoring and cleanroom quality assurance programs.
Review environmental monitoring data and implement corrective actions when necessary.
Ensure compliance with garbing, hand hygiene, cleaning, and disinfecting procedures.
Participate in internal audits and continuous quality improvement initiatives.
Assist with equipment qualification, calibration, and maintenance documentation.
Support regulatory inspections and accreditation activities.
Verify prescription orders using LifeFile pharmacy software.
Provide pharmacist consultation to patients and prescribers.
Answer clinical questions regarding compounded medications.
Assist with inventory management for sterile medications and pharmaceutical-grade raw materials.
Collaborate with providers to develop customized medication therapies.
Support workflow optimization and operational improvements.
Assist with training and competency assessment of sterile compounding personnel.

Requirements

Current Texas Pharmacist License in good standing.
Experience in sterile compounding and USP <797> compliance.
Experience compounding sterile medications from raw active pharmaceutical ingredients (APIs).
Strong understanding of sterile compounding principles, aseptic technique, and quality assurance.
Knowledge of USP <797>, applicable state regulations, and pharmacy best practices.
Excellent attention to detail and organizational skills.
Strong documentation and problem-solving abilities.
Ability to work independently while collaborating effectively within a multidisciplinary team.

Skills

Sterile compounding
USP <797> compliance
Aseptic technique
Quality assurance
Environmental monitoring
Regulatory compliance
Pharmacy software (LifeFile)
Patient consultation
Prescriber consultation
Inventory management
Workflow optimization

Location

Austin, Texas

Work Type

Full-Time
In Person

Benefits

Health Insurance
Dental Insurance
Vision Insurance
Paid Time Off
Employee Discount
Free Parking

About the Company

Our pharmacy is a growing compounding practice focused on delivering personalized, high-quality medications to patients across Texas and several additional states.
Our environment is collaborative, patient-centered, and provides an all-encompassing wellness ecosystem.