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Aseptic Compounding Specialist 503b

2 months ago


Birmingham, Alabama, United States Eagle Pharma Outsourcing LLC Full time
Job Overview

Position Summary:

The 503B Compounding Pharmacy Technician plays a crucial role in the formulation and mixing of sterile pharmaceutical products within a meticulously regulated environment. This position requires participation in a comprehensive training program to ensure proficiency in working within aseptic conditions, specifically in ISO 7 and ISO 5 settings. The technician is responsible for ensuring that all preparations comply with FDA and cGMP standards while managing inventory and maintaining an organized clean room.

Key Responsibilities: The following duties are essential to the role:

  • Possess a thorough understanding of current Good Manufacturing Practices (cGMP), United States Pharmacopeia General Chapter on Pharmaceutical Compounding – Sterile Preparations, and adhere to all relevant policies and Standard Operating Procedures.
  • Maintain accurate manufacturing records and complete all necessary documentation in accordance with cGMP, FDA, USP, and state pharmacy board regulations.
  • Operate and oversee technical, computerized compounding and filling equipment to ensure quality standards are upheld.
  • Conduct weighing and mixing activities associated with the preparation of sterile medications.
  • Prepare documentation and monitor outcomes for pharmaceutical quality assurance testing.
  • Ensure proper sterilization processes for devices and equipment under the supervision of a pharmacist.
  • Exhibit meticulous attention to detail, consistently meeting standards for potency, quality, purity, integrity, sterility, and endotoxin levels.
  • Monitor inventory levels to initiate re-orders for low stock or expiring chemicals, compounds, devices, and containers.
  • Verify materials prior to batch compounding.
  • Assist in the daily, weekly, and monthly cleaning of the workspace using appropriate disinfectants and techniques.
  • Complete end-of-batch reconciliation and inventory verification.
  • Successfully complete initial and ongoing evaluations of aseptic technique competency as outlined in the policies and procedures.
  • Achieve successful completion of all product validations and complex media fill verifications.
  • Perform additional duties as assigned by the department or pharmacy manager.

Minimum Qualifications:

  • Active registration as a pharmacy technician with the State Board of Pharmacy, in good standing.
  • Strong aseptic technique and excellent hand-eye coordination.
  • Experience in 503B sterile compounding is preferred.
  • PTCB Certification is preferred.
  • A high school diploma or equivalent (GED) is required.
  • Ability to work efficiently and accurately under time and volume pressures.

Physical Requirements:

  • Ability to lift up to thirty (30) pounds, including moving and carrying boxes.
  • Capability to sit or stand for extended periods.
  • Fine motor skills are essential.

Eagle Pharma Outsourcing LLC is committed to fostering a diverse and inclusive workplace for all employees.