Internship, Quality Information Technology

Employer
AveXis Inc.
Location
Libertyville, IL, US
Posted
Nov 03, 2018
Ref
2018-2604
Discipline
Quality, Quality Control
Hotbed
BioMidwest
Required Education
Bachelors Degree
Position Type
Full time
Overview

Ready to join a team committed to moving gene therapies into the clinical and commercial settings 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 in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission.

AveXis, Inc., a Novartis Company , 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 Summer Intern will work at the Libertyville site on various activities included, but not limited to, support the Quality IT Department, troubleshoot and/or validate software, help drive process improvements, help investigate deviations, provide risk assessments and other strategic analysis, and/or assist in the implementation and maintaining of Quality System lifecycles.

Responsibilities of primary importance are to ensure the successful time-sensitive development, validation, and lifecycle management of quality systems that support the manufacture and release of gene therapy products with minimal to zero deviations, promote a culture of quality and compliance while driving a sense of continuous improvement and operational excellence. Complete requisite training as well as all applicable policies and procedures related to the specific job function. The successful candidate will take accountability to ensure all documentation is complete and accurate, so issues can be addressed real time.

Responsibilities

  • Responsible for completing training on development, validation, and lifecycles of quality systems
  • Supports Quality IT Specialists in the rollout of new systems, and STARLIMS Phase 2 implementation support
  • Coordinates with Quality IT Project Managers and cross functional teams to move projects forward
  • Ensure cGMP documentation is being filled out correctly, training is current, and all quality requirements are being followed
  • Responsible for maintaining quality standards to meet cGMP requirements, 21 CFR Part 11, and internal company policies directly related to the Quality IT processes
  • Support tech transfer of new products and processes to ensure smooth transition from process development into compliant functioning quality systems
  • Look for opportunities to implement operational excellence and continuous improvement
  • Assist team to resolve any issues related to quality systems


Qualifications

  • Enrolled in a 4-year program, or recently completed a bachelor's degree in information technology, computer sciences, or life sciences
  • Excellent oral and written communication skills
  • 3.0 GPA and above


Additional Requirements:

Proficiency with Microsoft Office software (Word, Excel, PowerPoint).

Other Duties

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.