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Quality Assurance Associate

Company: AveXis Inc.
Location: Longmont
Posted on: June 15, 2019

Job Description:

OverviewReady to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission.AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene. The Quality Assurance Associate is responsible for implementing and maintaining robust Quality Systems for a new viral gene therapy manufacturing site. This person will be responsible for the strategic compliance to written procedures including but not limited to regulatory adherence and audit support, batch records and specifications, internal assessment processes, quality management review, annual product quality review (APQR), and monitoring compliance with all requirements of good manufacturing practice. The Quality Assurance Associate will provide expertise to transition a novel gene therapy into a commercially approved product. This individual must have a strong knowledge and application of the CFR's and cGMP's and have been involved in regulatory inspections. Full audit support of all internal and external audits in support of the product manufacture and launch.Responsibilities

  • Provide front-line strategic quality direction to GMP manufacturing operations in a controlled production environment.
  • Drive real-time review and approval of all batch related documentation.
  • Capable of working a shift-based schedule in alignment with Manufacturing needs.
  • Approve instruction sets, specifications, instructions and other Quality Assurance procedures directly related to operations and other cGMP activities.
  • Ensure all deviations from established procedures are appropriately documented and investigated to determine and fix root cause.
  • Ensure all required assessment is carried out to support Quality approval or rejection, as appropriate, for intermediates and bulk product.
  • Responsible for data integrity review of electronic raw data against the reported data.
  • Participate in site inspection preparation and response process.
  • Create and maintain an internal assessment program for the manufacturing facility.
  • Ensure a state of control and drive action where appropriate along with reporting on a specific set of quality and compliance metrics. Qualifications
    • Minimum B.S. degree in preferably microbiology, chemistry or biochemistry.
    • A minimum of 3-5 years of experience in biopharmaceutical based GMP manufacturing operations.
    • Experience with viral gene therapies and/or orphan disease indications is a plus.
    • Knowledge of FDA and EU regulations and experience in US and international regulatory agency inspections.
    • Direct experience reviewing and/or authoring standard operating procedures and partnering with operations on product related investigations and deviations.
    • Excellent oral and written communication skills with strong technical writing experience required.
    • Ability to synthesize data and summarize outcomes to provide recommendations on compliant path forward.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. #LI-RL1

Keywords: AveXis Inc., Denver , Quality Assurance Associate, Other , Longmont, Colorado

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