What are the responsibilities and job description for the Sterile Fill Technician position at Mark Cuban Cost Plus Drug Company, PBC?
The Sterile Fill Finish 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 :
WORK EXPERIENCE :
ADDITIONAL QUALIFICATIONS (OPTIONAL) :
