Sterile Compounding Technician 503b

2 weeks ago

Birmingham, United States Eagle Pharma Outsourcing LLC Full time
Job DescriptionJob Description

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: The responsibilities listed below are subject to change.


  • 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:

  • Ability to lift thirty (30) pounds. Moving, lifting, or carrying boxes.
  • Ability to sit/stand for extended periods
  • Fine motor skills

Revelation Pharma is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.


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