Clean Room Tech III, Ster Cmpg

4 days ago Be among the first 25 applicants

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.

601 Elmwood Ave, Rochester, New York, United States of America, 14642

Worker Subtype:
Regular

Full time

40

500160 Pharmacy SMH

UR - Day (United States of America)

UR URG 106 H

$21.36 - $29.90

General

Purpose:

Cleanroom Quality Control technicians are the highly‑skilled individuals who disinfect USP‑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 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.

• 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.
• Conduct airborne, non‑viable particle count testing in sterile compounding clean room areas as per the schedule established by departmental policy and federal standards. Utilize department‑owned LASAIR particle counting equipment after documented training and ongoing competency assessment(s).
• Conduct airborne viable particle (bioburden) testing in all sterile compounding clean room areas as per the schedule established by departmental policy and federal standards. Utilize department‑owned SAS airborne sampling equipment after documented training and ongoing competency assessment(s).
• Conduct surface sample testing for viable particles in sterile compounding clean room areas as per the schedule established by departmental policy and federal standards. Utilize 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 clean rooms.
• 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 standards. This includes daily, weekly, and monthly processes, including sanitization as required for situations involving shutdown of air handling systems in clean rooms as well as sanitizing equipment and medication storage areas related to clean rooms.
• Validation of Materials and Techniques for QM Program:
  Coordinate validation studies of technique and supplies for quality control program consistent with, or exceeding, USP standards, at the direction of the Program Director. Testing will include…