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University of Rochester Clean Rooms Quality Control Specialist - Bailey Road Compounding Center - 231843 in Rochester, New York

Clean Rooms Quality Control Specialist - Bailey Road Compounding Center Job ID 231843

Location Strong Memorial Hospital Full/Part Time Full-Time Favorite Job Regular/Temporary Regular Opening

Full Time 40 hours Grade 077 Pharmacy SMH

Schedule

HOURS AND DUTIES VARY; AS ASSIGNED BY MANAGER; WKENDS/HOLS

Responsibilities

Location: Bailey Road Compounding Center

GENERAL PURPOSE:

The primary goal of this position is to maintain and conduct quality control related to clean room operations across UR Medicine facilities. These activities include activities needed to meet regulatory requirements for sanitizing/disinfecting clean room facilities, testing for compliance with environmental standards, and overseeing and coordinating validation of technique for all clean room personnel.

This position will be primarily focused on maintaining clean room environmental standards as dictated by USP <797> requirements or more stringent standards of Good Manufacturing Practices as indicated. 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.

RESPONSIBILITIES:

Environmental Monitoring:

  • Conduct airborne, non-viable particle count testing in all clean room areas as per the schedule established by departmental policy and procedure. 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.

  • Conduct airborne viable particle (bioburden) testing in all clean room areas as per the schedule established by departmental policy and procedure. 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.

  • Conduct surface sample testing for viable particles in all clean room areas as per the schedule established by departmental policy and procedure. 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.

  • Maintenance of comprehensive documentation of all environmental monitoring activities and results as per departmental policy and procedure.

  • Sanitizes and disinfects clean room facilities consistent with departmental policy and procedures, and compliant with, or exceeding, USP <797> standards.

    Validation of Technique:

  • Coordinate and oversee validation studies of sterile technique for all clean room staff according to the schedule established in departmental policy and consistent with, or exceeding, USP <797> standards. Testing will include written competency evaluation, gloved fingertip sampling, garbing and gloving competency evaluation, media fill challenge, and other processes as defined in policy.

  • Maintenance of comprehensive documentation of the conduct and results of all validation of technique quality control testing as per departmental policy and procedure.

  • Sanitizes and disinfects all equipment and storage areas in clean room areas consistent with departmental policy and procedures, and compliant with, or exceeding, USP <797> standards.

  • Prepares and properly handles disinfecting chemical solutions consistent with University policy and regulatory requirements for the use of potentially hazardous chemicals per the Material Safety Data Sheet for each product.

  • Performs maintenance of comprehensive documentation of all sanitizing/disinfecting activities as per departmental policy and procedures.

  • Adheres to all disinfecting procedures conducted following an established weekly and monthly schedule for each clean room facility.

    QUALIFICATIONS:

  • Associate’s degree required

  • Bachelor’s degree in biology or other relevant science fields preferred

  • Prior hazardous material training, quality control experience, and/or clean room experience preferred

  • 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 and certification relevant to the use of equipment for environmental monitoring studies required.

    How To Apply

All applicants must apply online.

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