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Quality Control Sample Coordinator

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 Control Sample Coordinator provides sample control support at a Manufacturing facility. This includes the administration of QC in-process, release, and stability samples, associated document coordination, and collection of data. A potential candidate will possess an understanding of the requirements of Sample Coordination in a GMP laboratory. 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 Sample Coordinator 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 Sample Coordinator should be able to work effectively within the group, within Quality, and across site.Responsibilities

  • Usher Quality Control samples through the entire sample lifecycle maintaining sample integrity and chain of custody.
  • Generate sample submission forms for various testing facilities.
  • Collect sample forecasts to ensure lead time notice.
  • Confirm testing was complete when sample invoices arrive.
  • Follow/track shipments and help resolve shipping issues.
  • Log, receive, and aliquot incoming samples and take necessary actions if samples do not comply with SOPs.
  • Review and evaluate temperature data reports from temperature monitoring devices included with sample shipments.
  • Create equipment, inventory, and sample receipt and tracking logbooks/systems.
  • Draft sample management procedures.
  • Liaise with other departments including Quality Assurance, Manufacturing, Facilities, Supply Chain, and Warehouse to address compliance issues and to implement corrective actions and to improve programs.
  • Write and revise documents such as SOPs and technical reports.
  • Equipment preventative maintenance.
  • Perform other duties as assigned. Qualifications
    • Minimum B.A. or B.S. in a scientific field OR A.A or A.S. plus 2 years related experience in a GMP Quality Control Laboratory OR 4 years related experience in a GMP Quality Control Laboratory.
    • Ability to lift approximately 25 pounds.
    • Proficient in Microsoft Word, Excel, Power Point and other applications.
    • Ability to communicate and work in a team environment.
    • Comfortable in a fast-paced small company environment with proven ability to adjust workload based upon changing priorities.
    • Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of core duties.
    • Ability to think critically and demonstrate troubleshooting and problem-solving skills.
    • Excellent interpersonal, verbal and written communication skills.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 Control Sample Coordinator, Professions , Longmont, Colorado

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