Sterile Compounding Technician 503b

Eagle Pharma Outsourcing LLC

Birmingham, AL

$19 to $23 Hourly
Full-Time

Job 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 <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: