• Quality Assurance Facility, Systems and Equipment Specialist

    Posting Date 3 months ago(5/10/2018 4:49 PM)
    Requisition ID
    2018-4466
    Job Location(s)
    Pittsburgh PA United States
    Position Type
    Full Time
    Company
    Cook Myosite Inc.
    Category
    Quality
  • Overview

    Cook MyoSite Incorporated, a division of Cook Incorporated, is a growing, forward-thinking biotechnology organization seeking a full time Quality Assurance Facility, Systems and Equipment Specialist. This role will be responsible for reviewing and facilitating the approval of all Quality System documentation pertaining to Facility, Systems, and Equipment Functions.

    Responsibilities

    • Understand, interpret, and apply regulatory requirements pertaining to facilities, equipment, and utilities in an FDA-regulated environment
    • Function as a quality subject matter expert in the areas of facility, utilities, and equipment, as a quality representative in these areas on project teams, and be capable of responding to auditors’ and inspectors’ questions
    • Review and approve/reject the design and validation of facilities, equipment, and utilities within the organization to ensure the systems planned and qualified/validated in a compliant manner that is consistent with their intended use
    • Facilitate authoring of investigations, especially those pertaining to facility and equipment deviations, and assist in identification of appropriate CAPAs to address problems

    • Review and approve/reject, facility, equipment and utility change controls/requests, SOPs, maintenance and calibration reports, and facility records such as pest control reports, to ensure all are maintained in a compliant manner, in accordance with their intended use
    • Review and approve prepared material, intermediate, and final product batch records, and disposition accordingly
    • Maintain regular and punctual attendance
    • Must maintain company quality and safety standards

    Qualifications

    • Must have, at a minimum, a Bachelor's degree in any Life Science,  related Engineering field, or acceptable related experience
    • Knowledge or ability to learn GMP aspects of facilities and equipment, as well as, sufficient biology to understand the details of a cell therapy manufacturing in an FDA-regulated environment

    • Must be able to multi-task
    • Excellent problem solving skills and ability to work in collaborative and independent work situations and environments with minimal supervision
    • Project management skills are a plus

     

    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 with reasonable accommodation
    • Laboratory and office setting
    • Ability to work under specific time constraints

    • Must perform PPE gowning procedures to enter BioSafety Level II including safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt) and appropriate shoes required on occasion
    • 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, extended work hours and/or extra work hours, sometimes on short notice as required

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