• Quality Control Analyst (Microbiology / Environmental Monitoring)

    Job Locations US-IL-Libertyville
    Posted Date 4 weeks ago(6/19/2018 4:03 PM)
    Job ID
    2018-1305
    # of Openings
    1
    Category
    Quality
  • Overview

    Ready to join a team committed to moving gene therapies into the clinical setting for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science to treat rare and life-threatening genetic diseases starting with our clinical-stage, proprietary gene therapy candidate, AVXS-101. We are at the beginning of an incredible journey, and are looking for passionate individuals to join us on this important mission.

     

    AveXis, Inc. is a clinical-stage gene therapy company, dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product candidate, AVXS-101, is our proprietary gene therapy product candidate currently in development for the treatment of spinal muscular atrophy, or SMA, Type 1, the leading genetic cause of infant mortality, and for the treatment of SMA Type 2. The U.S. Food and Drug Administration, or FDA, has granted AVXS-101 Orphan Drug Designation for the treatment of all types of SMA and Breakthrough Therapy Designation, as well as Fast Track Designation for the treatment of SMA Type 1. In addition to developing AVXS-101 to treat SMA Type 1 and Type 2, we also plan to develop other novel treatments for rare neurological diseases, including Rett syndrome (RTT) and a genetic form of amyotrophic lateral sclerosis (ALS) caused by mutations in the superoxide dismutase 1 (SOD1) gene.

     

    The QC Analyst provides Environmental Monitoring (EM) and Microbiological expertise at the AveXis GMP Manufacturing facility in Libertyville IL.  Responsibilities include, but are not limited to environmental monitoring, routine testing, method qualification/validations, excursion notifications, and trend reports and other associated activities.  A potential candidate will possess an understanding of Environmental Monitoring and Microbiological techniques.  Additional responsibilities include adherence to all GMP requirements, a basic understanding of FDA/EMEA regulations, effective interactions/communication with Quality management, personal development, and support of investigations.  The QC Analyst may also support the Manager for activities related to training of employees, compliance with GMP, and identifying and implementing corrective and preventive actions.  The QC Analyst should be able to work effectively within the group, within Quality, and across site.

    Responsibilities

    • Perform environmental monitoring for HVAC (viable air, viable surface, total particulates), purified water (conductivity, TOC, bioburden) and compressed gases (hydrocarbon, dew point and bioburden) systems. Serve as subject matter expert in this area.
    • Review and trend EM data and publish quarterly and annual trend reports.
    • Conduct thorough investigations to determine root cause of environmental excursions and other non-conforming results and implement appropriate corrective and preventative actions in a timely manner.
    • Establish and maintain library of environmental isolates.
    • Perform microbiological testing such as bioburden, endotoxin, growth promotion, viability and gram staining, etc.
    • Liaise with other departments including Quality Assurance, Manufacturing and Facilities to address compliance issues and to implement corrective actions and to improve programs.
    • Perform other established analytical methods such as BCA, SDS-PAGE, TOC, conductivity, and pH testing to support QC operations.
    • Participate in assay troubleshooting, qualification and validation.
    • Manage the use and maintenance of scientific equipment and instrumentation, computer systems;
    • Write and revise documents such as SOPs and technical reports.

    Qualifications

    • Minimum B.A. or B.S. in microbiology or related scientific field
    • Minimum of 2 years of environmental monitoring and microbiology experience in a GMP laboratory.
    • Excellent oral and written communication skills with strong technical writing experience required.

     

    The level of this position will be based on the final candidate’s qualifications.

     

    Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. 

     

    AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.

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