Sterile Compounding Technician - cGMP, QA & Process Excellence

Empower Pharmacy; Houston (TX); On-site; USD 52,000 - 64,000; Full time

Job summary

Empower Pharmacy in Houston seeks a Pharmacy Technician, Sterile Compounding, to support aseptic preparation within our 503A/503B environment, ensuring compliant batch records.

Responsibilities include aseptic execution, equipment operation, cleanroom maintenance, and strict adherence to USP 797/800 and cGMP standards.

Apply LEAN/5S to improve workflows, train technicians, and collaborate across shifts to sustain quality, safety, regulatory readiness, and continuous improvement.

Qualifications

• 2+ years of cGMP or LEAN manufacturing experience.
• High school diploma or equivalent.
• Certified Pharmacy Technician registered with the Texas State Board of Pharmacy.
• Sterile/IV compounding accreditation by the Accreditation Council for Pharmacy Education.

Responsibilities

• Aseptic Execution: Perform sterile compounding using validated aseptic techniques within ISO-classified cleanrooms.
• Process Compliance: Execute compounding processes in line with batch records, SOPs, USP 797/800, cGMP, and regulatory requirements.
• Equipment Operation: Operate and monitor compounding and sterilization equipment to support reliable production flow.
• Documentation Accuracy: Complete compounding documentation and batch records with precision, ensuring traceability and inspection readiness.
• Deviation Response: Identify, elevate, and support investigation of deviations using root cause analysis.
• Inspection Readiness: Maintain readiness for internal and external audits by adhering to protocols and documentation reviews.
• Environment Control: Maintain cleanroom integrity through cleaning, sterilization, and environmental monitoring.
• Workflow Optimization: Apply LEAN/5S to streamline workflows and reduce waste.
• Team Collaboration: Train new technicians and standardize best practices across shifts.

Skills

Aseptic technique

USP 797/800

cGMP standards

Sterile compounding calculations

Batch documentation

LEAN methodology

Root cause analysis

Cleanroom gowning

Education

Certified Pharmacy Technician registered with TX Board

Sterile/IV compounding accreditation (ACPE)

High school diploma or equivalent

2+ years cGMP or LEAN manufacturing experience

Job description

Empower Pharmacy in Houston seeks a Pharmacy Technician, Sterile Compounding, to support aseptic preparation within our 503A/503B environment, ensuring compliant batch records.

Responsibilities include aseptic execution, equipment operation, cleanroom maintenance, and strict adherence to USP 797/800 and cGMP standards.

Apply LEAN/5S to improve workflows, train technicians, and collaborate across shifts to sustain quality, safety, regulatory readiness, and continuous improvement.