Job Details
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 <797> 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.