Quality Assurance Training Associate

Overview

Ready 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 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 Training Management 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 in ongoing management of site training curricula and content.
• Organize regularly scheduled training activities.
• Create and present trending and metrics reports on
• Provide administrative support for the train-the-trainer program and qualification of all area trainers for content
• With the assistance of departmental management, plan and develop competency assessments for
• 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
• Solid organizational and time management skills.
• Ability to operate in a highly detailed
• Experience with facilitation and performance of presentations.
• Works precisely according to procedures, rules and regulations, has a passion for continuous improvement and
• Demonstrates the highest ethical standards, actively promotes trust, respect and integrity in all dealings both inside and outside the Company.

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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