• Quality Control Specialist

    Job Locations US-IL-Libertyville
    Posted Date 1 week ago(7/8/2018 5:59 PM)
    Job ID
    2018-1334
    # 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 Specialist provides Environmental Monitoring/Microbiological, Chemistry or Biochemistry expertise at the AveXis GMP Manufacturing facility in Libertyville IL.  This includes technical writing, routine testing, and all other associated activities.  The QC Specialist responsibilities include, but are not limited to, training, sampling, routine testing, method qualification/validations, investigations, and technical writing.  A potential candidate will possess a strong understanding of QC testing techniques.  Additional responsibilities include adherence to all GMP requirements, a basic understanding of FDA/EMEA regulations, effective interactions/communication with Quality management, and personal development.  The QC Specialist may also support the Manager for activities related to interviewing and training of employees, compliance with GMP, and identifying and implementing corrective and preventive actions.  The QC Specialist should be able to work effectively within the group, within Quality, and across site.

    Responsibilities

    • Perform Environmental Monitoring/Microbiological, Chemistry or Biochemistry testing.
    • Serve as subject matter expert in this area representing Quality Control during audits and inspections.
    • Review and trend data and publish quarterly and annual trend reports.
    • Conduct thorough investigations to determine root cause of OOS investigations and other non-conforming results and implement appropriate corrective and preventative actions in a timely manner.
    • Liaise with other departments including Quality Assurance, Manufacturing and Facilities to address compliance issues and to implement corrective actions and to improve programs.
    • 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 scientific related field.
    • Minimum of 5 years in a GMP Quality Control laboratory.
    • Working knowledge of multiple assays.
    • Experience with method validation and qualification.
    • Experience leading small teams and projects.
    • Self-reliant, a good problem solver and results-oriented, and comfortable working in a fast-paced environment.
    • An excellent and persuasive communicator.
    • Energetic, flexible, collaborative and proactive.

     

    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.

     

     

    Options

    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed