Senior GMP Training Specialist

Employer
AveXis Inc.
Location
Longmont, CO, US
Posted
Sep 27, 2019
Ref
2019-3718
Required Education
Bachelors Degree
Position Type
Full time
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.

AveXis is seeking a Senior Training Specialist who will be responsible for supporting the Senior Training Manager in completion of site training objectives and goals. A training business partner supporting training requests at the site. Assist in providing identification and development of training content. Primary contact for external customers to identify, develop, plan, implement, and project manage system improvements. Create, assign, and maintain curricula at the site and global level. Support Senior Training Manager as a team lead.

Responsibilities

  • Provide efficient and timely customer service, ensuring relevant documentation is processed appropriately.
  • Partner with functional areas to conduct monitoring of training compliance status, effectiveness checks and trend results.
  • Provide support in development of training materials and knowledge assessments for area processes.
  • Support the QA Training team in completion of site training objectives and goals.
  • Support regulatory inspections and internal audits.
  • Assist QA Training Manager with the review of training materials and training records, and the annual GMP training.
  • Manage projects as assigned.
  • Support additional quality systems including audits.
  • Deliver site GDP training and ongoing site refreshers.
  • Lead annual curriculum audit review and provide guidance to department leaders.
  • Create job aids for Quality Systems.
  • Develop skills and knowledge of site employees.
  • Monitor and evaluate training program effectiveness.
  • Support the Training Manager in the writing, auditing, and updating content in the EDMS.


Qualifications

  • Bachelor's degree preferred and 5+ years of experience in Training within a GMP, regulatory or pharmaceutical environment.
  • Working knowledge of MS Word, Excel, PowerPoint and other eLearning software.
  • Experience with instructional design and adult learning concepts.
  • Solid organizational and time management skills.
  • Ability to operate in a highly detailed manner.
  • Proven facilitation and presentation skills.
  • Must be able to work precisely according to procedures, rules and regulations and have a passion for continuous improvement and quality.
  • 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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