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Clean Room Tech III, Ster Cmpg
- University of Rochester (Rochester, NY)
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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.
Job Location (Full Address):
601 Elmwood Ave, Rochester, New York, United States of America, 14642
Opening:
Worker Subtype:
Regular
Time Type:
Full time
Scheduled Weekly Hours:
40
Department:
500160 Pharmacy SMH
Work Shift:
UR - Day (United States of America)
Range:
UR URG 106 H
Compensation Range:
$21.36 - $29.90
_The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job's compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations._
Responsibilities:
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.
ESSENTIAL FUNCTIONS
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.
MINIMUM EDUCATION & EXPERIENCE
+ Associate’s degree. Required
+ 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
+ Or equivalent combination of education and experience. Required
KNOWLEDGE, SKILLS AND ABILITIES
+ Background in biology or other relevant applied science. Required
LICENSES AND CERTIFICATIONS
+ 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
The University of Rochester is committed to fostering, cultivating, and preserving an inclusive and welcoming culture to advance the University’s Mission to Learn, Discover, Heal, Create – and Make the World Ever Better. In support of our values and those of our society, the University is committed to not discriminating on the basis of age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion, creed, sex, sexual orientation, citizenship status, or any other characteristic protected by federal, state, or local law (Protected Characteristics). This commitment extends to non-discrimination in the administration of our policies, admissions, employment, access, and recruitment of candidates, for all persons consistent with our values and based on applicable law.
Notice: If you are a **Current Employee,** please **log into myURHR** to search for and apply to jobs using the Jobs Hub. Your application, if submitted using this portal, cannot be moved forward.
Learn. Discover. Heal. Create.
Located in western New York, Rochester is our namesake and our home. One of the world’s leading research universities, Rochester has a long tradition of breaking boundaries—always pushing and questioning, learning and unlearning. We transform ideas into enterprises that create value and make the world ever better.
If you’re looking for a career in higher education or health care, the University of Rochester may offer the perfect opportunity for your background and goals.
At the University of Rochester, we are committed to fostering, cultivating, and preserving an inclusive and welcoming culture and are united by a strong commitment to be ever better—Meliora. It is an ideal that informs our shared mission to ensure all members of our community feel safe, respected, included, and valued.
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Clean Room Tech III, Ster Cmpg
- University of Rochester (Rochester, NY)