Job Description

The Sterile Compounding Pharmacy Technician is responsible for performing aseptic technique to fill sterile injectable products and preparations. This employee should be focused on the sterility assurance of both manufactured and compounded drugs made by the Company. 

DUTIES & RESPONSIBILITIES :

• Works as a sterile fill finish operator to perform aseptic technique in a clean room environment. 
• Assist other departments with the qualification of manufacturing equipment in support of facility start up. 
• Participate in the execution of all phases and facets of drug product formulation, fill and visual inspection, as applicable.
• Performs manufacturing and compounding activities in accordance with current Good Manufacturing Practices. 
• Performs compounding calculations and completes appropriate documentation. 
• Perform cleaning and sanitization of aseptic manufacturing areas. 
• Demonstrates appropriate use of garbing and compliance with 21 CFR 211, 503B guidelines, as well as other sterile fill finish regulations. 
• Performs operations related to aseptic filling including but not limited to filter integrity testing, inventory accountability, autoclaving, and working with an automatic filling isolator.
• Execute production recipes, check-in equipment, and perform material movements using automated computer software applications.
• Completes and reviews batch records and logbooks in accordance with cGMP standards and follows written procedure. 
• Ability to work and coordinate with the mixing operators to ensure timely production of scheduled lots. 
• Work effectively and efficiently in a team-oriented environment to ensure maximum and high-quality output. 
• Ensure all equipment and facilities are maintained. 
• Utilizes proper judgement to perform other duties. 
• Complies with applicable local, state, and federal laws, rules, and regulations. 

EDUCATION AND/OR TRAINING :

• High School diploma or general education degree (GED) required  
• Knowledge of aseptic techniques (IV Certified, preferred) 
• Knowledge and demonstrated understanding of Good Manufacturing Practices (GMPs) and how it applies to specific responsibilities and manufacturing operations  
• Licensed and registered as a Pharmacy Technician (CPhT) preferred  

WORK EXPERIENCE :

• A minimum of 5 years’ experience working in a quality regulated, pharmaceutical environment or facility
• Familiarity with prescription drug products, sterile compounded products, and/or biologic drug products 
• Experience / participated in FDA or similar regulatory inspections 
• Maintain current knowledge in up-to-date regulatory/industry standards related to Environmental Monitoring and Microbiology, as well as facilitate proper dissemination of information 
• Proficient with MS Office application skills. 

ADDITIONAL QUALIFICATIONS (OPTIONAL):

• Self-motivated and detail oriented 
• Ability to carry out detailed written and verbal work instructions
• Capable of lifting up to 20 – 25 kilograms and stand for extended periods of time for consecutive days 
• Able to work with hazardous substances (drugs)

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