• Quality Control Microbiology Assistant

    Posting Date 4 months ago(2/5/2019 3:00 PM)
    Requisition ID
    2019-5957
    Job Location(s)
    Pittsburgh PA United States
    Travel
    Less than 10%
    Position Type
    Full Time
    Company
    Cook Myosite Inc.
    Category
    Quality
  • Overview

    Cook MyoSite, Inc. is on a mission to make regenerative medicine a part of everyday medicine. We’re investigating our core technology, autologous muscle-derived cells, for the potential treatment of several muscle-related disorders. We at Cook MyoSite have the potential to make a difference in the lives of countless people around the world, and we also have the potential to make a difference in yours. Joining our team is an opportunity to ignite your passion, grow your potential, and define your purpose. If you’re curious, motivated by helping others, and driven by integrity, we invite you to apply below.

     

    The Quality Control Microbiology Assistant at Cook MyoSite will assist GMP testing and perform environmental monitoring activities to support lot release and in-process testing.

    Responsibilities

    • Preparation of equipment and instrumentation for further use in analytical assay and/or microbiological testing
    • Perform environmental monitoring activities such as collecting viable air, surface EM samples, non-viable particulate samples, and reading of EM plates
    • Use of Laboratory Information Management Systems (LIMS) to identify samples to be processed
    • Support to maintain cleanroom environment below alert limits by participating in and following established cleaning practices and cleanroom behavior
    • Receives/collects submitted samples

    • Maintain instrumentation and supporting documentation in a GMP compliant manner
    • Cleaning and general maintenance of labs including monthly inventories and removal of expired products

    Qualifications

    • Associates degree in any Life Science with 1-3 years’ experience in a laboratory or GMP environment
    • Previous experience with monitoring production environments preferred
    • Must possess excellent organizational skills and the ability follow complex processes, procedures and systems
    • Demonstrate critical thinking and ability to execute goals set by the organization and Department Manager

    • Proficiency in MS Office and other general office equipment
    • Must maintain a high level of professionalism, business acumen
    • Must have effective verbal, written and interpersonal skills
    • Maintain composure and competence under stressful situations; flexibility and adaptability
    • Ability to work in collaborative and independent work situations and environments with minimal supervision
    • Basic understanding of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical product manufacturing

     

    Physical Requirements:

    • Must be able to sit at a desk for extended periods of time
    • Physically capable of standing, stooping, kneeling, climbing, reaching, twisting, and bending with or without reasonable accommodation
    • 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

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

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