Clean Room Tech III, Ster Cmpg

University of Rochester • City of Rochester, NY

28d • $21 - $30 • Onsite

About The Position

As a community, the University of Rochester is defined by a deep commitment to Meliora - Ever Better. Embedded in that ideal are the values we share: equity, leadership, integrity, openness, respect, and accountability. Together, we will set the highest standards for how we treat each other to ensure our community is welcoming to all and is a place where all can thrive. GENERAL PURPOSE Cleanroom Quality Control technicians are the highly-skilled individuals who both disinfect USP <797>- regulated or cGMP-regulated sterile compounding environments throughout URMC pharmacy facilities, and assist with the ongoing mandated microbiological air and surface monitoring program to assure these critical compounding sites remain in microbial control, helping to ensure patient safety from contaminated compounded sterile medications. These individuals may also assist with USP <800> Hazardous Drug Handling by implementing the environmental surface monitoring program at the discretion of the department’s Quality Management Program Director. They coordinate and oversee technique development for new processes and supplies related to same and ensure accurate and thorough documentation and records for processes, implementing changes in collaboration with Program Director as standards dictate. It is expected that this person will be independent, self-directed and will regularly identify projects and needs of the department without having to be directly asked. While broad goals and objectives will be defined, it is anticipated that this individual will identify and pursue the detailed projects needed to address the goals and objectives.

Requirements

• Associate’s degree. Required
• Or equivalent combination of education and experience. Required
• Background in biology or other relevant applied science. Required
• All individuals hired will need to complete UR required training for the handling of hazardous materials and will need to complete training relevant to the use of equipment for environmental monitoring studies. Required

Nice To Haves

• Bachelor’s degree in biology or other relevant applied science fields. Preferred
• Prior hazardous material training, quality control experience, and/or clean room experience. Preferred

Responsibilities

• Environmental Monitoring: Mandated interim internal testing program occurring “off cycle” from required outside/third-party vendor certification pharmacy cleanroom spaces and equipment Areas to be tested and conditions under which testing (or retesting) must be conducted will be defined in current policy, which may be updated or revised as deemed necessary by area clean room supervisors, departmental leadership, engineering or infection control. Conducts airborne, non-viable particle count testing in sterile compounding clean room areas as per the schedule established by departmental policy and federal standards. Utilizes department-owned LASAIR particle counting equipment (or other mandated/upgraded equipment per regulation or practice standards) after documented training and ongoing competency assessment(s). Conducts airborne viable particle (bioburden) testing in all sterile compounding clean room areas as per the schedule established by departmental policy and federal standards. Utilizes department-owned SAS airborne sampling equipment (or other mandated/upgraded equipment per regulation or practice standards) after documented training and ongoing competency assessment(s). Conducts surface sample testing for viable particles in sterile compounding clean room areas as per the schedule established by departmental policy and federal standards. Utilizes specific aseptic technique to obtain high-quality surface samples on manual agar growth media plates after documented training and ongoing competency assessment(s). Conduct comprehensive incubation and review of agar plates for accurate environmental assessment of sterile compounding cleanrooms. Maintain thorough documentation of all environmental monitoring activities and results, trending data for review by senior management.
• Sanitizes and disinfects pharmacy sterile compounding clean room facilities consistent with departmental policy and procedures, and compliant with, or exceeding, USP <797> standards. This includes daily, weekly, and monthly processes, including sanitization as required for situations involving shutdown of air handling systems in cleanrooms as well as sanitizing equipment and medication storage areas related to cleanrooms.
• Validation of Materials and Techniques for QM Program: Coordinate validation studies of technique and supplies for quality control program consistent with, or exceeding, USP <797> standards, at the direction of the Program Director. Testing will include effectivity studies on disinfectants, supplies, and techniques. Maintenance of comprehensive documentation of the conduct and results of all validation of technique quality control testing as per departmental policy and procedure. Assist in development and implementation of hazardous drug surface surveillance program, establishing procedures for usage of test kits and ensuring applicable sites are tested Provide input on standard operating procedures and data recording tools on all sanitizing/disinfecting, environmental control, and hazard drug surface testing activities.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree