Clean Room Tech 3 - Sterile Compounding

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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 - Night (United States of America)

Range:

UR URG 106 H

Compensation Range:

$21.78 - $30.53

Responsibilities:

Disinfects USP <797>- regulated or cGMP-regulated sterile compounding environments throughout pharmacy facilities and assists with the ongoing mandated microbiological air and surface monitoring program to ensure site microbial control. Assists with and implements USP <800> Hazardous Drug Handling environmental surface monitoring program at the department's discretion. Coordinates and oversees technique development for new processes and supplies related to same and ensures accurate and thorough documentation and records for processes, implementing changes in collaboration with leadership as standards dictate.

ESSENTIAL FUNCTIONS

• Sanitizes and disinfects pharmacy sterile compounding clean room facilities consistent with departmental policy and procedures and compliant with, or exceeding, USP standards. Sanitizes, as required, for situations involving the shutdown of air handling systems in cleanrooms. Sanitizes equipment and medication storage areas related to cleanrooms.
• Conducts interim internal testing program occurring off-cycle from required outside/third-party vendor certification pharmacy cleanroom spaces and equipment as defined in current policy. Maintains knowledge of and adheres to all policy updates/revisions. Conducts airborne, non-viable particle count testing, airborne viable particle testing, and surface sample testing for viable particles in all sterile compounding clean room areas, as per the schedule established by departmental policy and federal standards. Utilizes specific aseptic techniques to obtain high-quality surface samples on manual agar growth media in sterile compounding clean room areas.
• Conducts comprehensive incubation and review of agar plates for accurate environmental assessment of sterile compounding cleanrooms. Maintains thorough documentation of all environmental monitoring activities, results and trending data for review by senior management.
• Coordinates validation and effectivity studies of technique and supplies for quality control program consistent with, or exceeding, USP standards. Maintains comprehensive documentation of the conduct and results of all validation of technique quality control testing, as per departmental policy and procedure.
• Provides input on standard operating procedures and data recording tools on all sanitizing/disinfecting, environmental control, and hazard drug surface testing activities.
• Assists in the development and implementation of hazardous drug surface surveillance program. Establishes procedures for usage of test kits and ensuring applicable sites are tested.
• Other duties as assigned.

MINIMUM EDUCATION & EXPERIENCE

• Associate's degree required
• Bachelor's degree in biology or other relevant applied science field required
• Or equivalent combination of education and experience
• Prior hazardous material training, quality control experience, and/or clean room experience preferred

KNOWLEDGE, SKILLS AND ABILITIES

• Background in biology or other relevant applied science required

LICENSES AND CERTIFICATIONS

• Completion of UR required training for the handling of hazardous materials and use of equipment for environmental monitoring studies within 30 days required

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