Quality Pharmacy Technician 503B

Job Description

Job Description

Role Summary

The Quality Technician ensures that all compounded products are manufactured in accordance with current Good Manufacturing Practices (GMP) and also meet all internal specifications. This position is responsible for performing a number of manual and automated quality assurance checks on in-process products and finished goods. This position requires strong organizational skills and the ability to prioritize work and respond to customer demands in a timely fashion are critical requirements of this position. This position is responsible for working collaboratively with other personnel in the Quality Department to ensure the highest quality product is delivered to the consumer.

Job Activities and Responsibilities :

• Collect and send samples of compounded sterile preparations (CSPs) for sterility, potency, and endotoxin testing.
• Conduct environmental monitoring (e.g., air and surface sampling) in cleanrooms to ensure compliance with regulatory standards.
• Perform visual inspection of finished drug products.
• Maintain incubation schedules of environmental monitoring sample plates and document results in associated reports and batch records.
• Maintain accurate and thorough records of all testing and inspections.
• Ensure all documentation complies with FDA 503B regulations, USP standards, and internal SOPs.
• Review batch records and verify that all procedures were followed correctly.
• Assist in internal and external audits to ensure compliance with FDA regulations, USP

, USP

, and other applicable guidelines.

Qualifications and Education Requirements

Physical requirements :

Benefits :