503B Sterile Compounding Technician

Job Summary

The 503B Sterile Compounding Technician is responsible for the preparation and admixture of sterile pharmaceutical products in a highly controlled, regulated environment. This technician will undergo a stringent training program to become qualified to work in aseptic environment inside ISO 7 rooms and ISO 5 workspaces, ensuring admixtures are completed properly per FDA and cGMP requirements. The 503B Sterile Compounding Technician is also responsible for managing product inventory and supplies and is expected to maintain a highly organized clean room. This technician will work with the team to ensure compliance to standard operating procedures and regulatory requirements.

Job Activities and Responsibilities

• Sterile compounder must have knowledge of current Good Manufacturing Practices (cGMP), United States Pharmacopeia General Chapter Pharmaceutical Compounding – Sterile Preparations, FDA regulations, and follow policies and Standard Operating Procedures.
• Maintain manufacturing records and completes all required documentation in compliance with cGMP, FDA, USP and pharmacy state board regulatory guidelines.
• Operate and monitor technical, computerized compounding/filling equipment ensuring quality standards are maintained.
• Responsible for weighing and mixing activities associated with the compounding of sterile medications.
• Prepare records and monitor results for pharmaceutical quality assurance testing.
• Responsible for device and/or equipment sterilization processes under pharmacist supervision.
• Position requires close attention to detail. Standards for potency, quality, purity, integrity, sterility, and endotoxin content must be consistently met.
• Monitor inventory levels for re-order of low inventory or expiring chemicals, compounds, devices and/or containers.
• Verify materials for use in batch compounding.
• Support daily, weekly, and monthly cleaning of the environment with appropriate disinfectants and techniques.
• Complete end of batch reconciliation and count verification.
• Initial and ongoing aseptic technique competency evaluation must be successfully completed as required in the policies and procedures.
• Successful completion all product validations and advances complex media fill verifications.
• Other duties as assigned by department or pharmacy manager.

Minimum Qualifications

• Active pharmacy technician registration with the State Board of Pharmacy. License must be in good standing.
• Strong aseptic technique and hand-eye coordination
• 503B Sterile compounding experience (preferred)
• PTCB Certification (preferred)
• High school diploma or general education degree (GED) required
• Ability to work quickly and accurately under time and volume constraints

Physical Requirements

• Proficient in using a computer and related equipment, including printers and fax machines.
• Ability to sit or stand for extended periods.
• Effective communication skills via telephone and email.
• Capable of lifting up to 40 pounds as needed.
• 20/20 vision (with or without corrective aids) required for visual inspection of drug products, in accordance with legal requirements.