• Aseptic Reset Assistant

    Posting Date 1 week ago(12/6/2018 5:33 PM)
    Requisition ID
    2018-5737
    Job Location(s)
    Pittsburgh PA United States
    Travel
    None
    Position Type
    Full Time
    Company
    Cook Myosite Inc.
    Category
    Biomedical/Biotechnology
  • Overview

    The Aseptic Reset Assistant at Cook MyoSite will ensure the uninterrupted manufacturing of cellular products by providing an adequate supply of resources, maintaining manufacturing equipment, and laboratory spaces.

    Responsibilities

    • Performs duties with strict adherence to the company quality system, standard operating procedures, and cGMPs
    • Executes daily schedule with little to no oversite
    • Ability to obtain and maintain required internal company qualifications, including but not limited to; gowning qualification
    • Follows proper cleanroom behavior and aseptic practices while working inside manufacturing suite
    • Ensures, and maintains, the availability of adequate resources (equip, inventory/materials, documentation, etc.) for the completion of daily production tasks

    • Responsible for inventory management through use of a paper and electronic inventory systems
    • Responsible for the execution of transporting, handling, and the disinfection of manufacturing materials in accordance to established procedures for use within a cleanroom environment
    • Responsible for stocking and maintenance of gowning supplies

    • Performs routine sanitization of laboratories and the manufacturing suite with required use of half-faced respirator and/or PAPR along with additional PPE
    • Performs routine sanitization of laboratory manufacturing equipment in accordance with set procedures
    • Collects and properly dispose of biohazard waste
    • Completes and reviews associated documentation in a timely fashion
    • Troubleshoots problems, bringing unusual problems (i.e. potential deviations) to the attention of the supervisor
    • Performs periodic Production related data entry
    • Uphold company quality and safety standards in addition to employee expectations
    • Maintain regular and punctual attendance
    • Assists in training new personnel
    • Availability to work required evening/off hour shifts, which may include; weekend or weekdays, extended hours, and holidays

    Qualifications

    • At minimum, an Associate’s degree in any biotechnology or life science field, or at least 2 years’ experience in a laboratory environment

    • Ability to successfully complete Support Assistant training program

    • Critical thinking and organizational skills
    • Excellent oral and written communication skills
    • Must work and interact effectively and professionally with others
    • Excellent problem-solving skills and ability to work in collaborative and independent work situations and environments with minimal supervision

     

    Physical Requirements:

    • Must be able to sit at desk, in meetings and/or work on a computer 
    • Physically capable of standing, stooping, kneeling, climbing, reaching, twisting and bending
    • Majority of some days spent on feet in laboratory setting
    • Climbing a mobile ladder and/or other types of ladders on occasion with or without reasonable accommodation
    • Must perform PPE gowning procedures daily to enter BioSafety Level II including laboratory scrubs (shirt and pants), frock, hood, and appropriate shoes as required in areas associated with this position

    • Must be able to lift/push/pull 30 pounds
    • Potential limited exposure to hazardous chemicals and/or harsh disinfectants while in BioSafety Level II
    • Must be able to work extended hours beyond normal work schedule to include, but not limited to; evenings, weekends, holidays, extended work hours and/or extra work hours sometimes on short notice as required
    • Ability to work under specific time constraints
    • Laboratory and office setting
    • Ability to perform job functions while wearing cleanroom gowning and either a half-face respirator or PAPR device for several hours

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