Quality Assurance Training Associate

Job Locations US-IL-Libertyville
Posted Date 1 month ago(1/18/2018 7:50 AM)
Job ID
2018-1095
# 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 training department is responsible for developing the skills and knowledge of site employees, allowing development within their current role, as well as enhancing careers within AveXis.  The Quality Assurance Training Associate is responsible for the day-to-day operation of the Learning Management System, monitoring and reporting compliance to the program, and assisting with the identification and development of training content.

Responsibilities

  • Provide efficient and timely customer service, ensuring relevant documentation is completed and processed appropriately.

  • Partner with functional areas to conduct ongoing monitoring of training compliance status, effectiveness checks, and trend results as appropriate

  • Provide support in the development of training materials and knowledge assessments for area SOPs

  • Provide support to the QA Training Manager in completion of site training objectives

  • Partner with functional areas to draft, implement, approve, and revise training materials

  • Facilitate and/or organize instructor led training courses

  • Assist QA Training Manager with annual GMP training to the Libertyville Site

  • Assist in ongoing management of site training curricula and content

  • Organize regularly scheduled training activities

  • Create and present trending and metrics reports on training

  • Provide administrative support for the train-the-trainer program and qualification all area trainers for content delivery

  • With the assistance of departmental management, plan and develop competency assessments for personnel

  • Maintenance of compliance related training records in and outside of the electronic Learning Management System (LMS)

Qualifications

  • Bachelor's degree preferred and 1-3 years' experience in Training within a regulatory or pharmaceutical environment; in lieu of the educational requirement, a minimum of 4-6 years of equivalent experience is acceptable.
  • Experience with electronic Learning Management Systems
  • Working knowledge of MS Word, Excel, PowerPoint and other eLearning software
  • Solid organizational and time management skills
  • Ability to operate in a highly detailed manner
  • Experience with facilitation and performance of presentations
  • Works precisely according to procedures, rules and regulations, has a passion for continuous improvement and qualityDemonstrates the highest ethical standards, actively promotes trust, respect and integrity in all dealings both inside and outside the company.

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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