Quality Assurance Documentation Specialist - Gene Therapy Manufacturing

Employer
AveXis Inc.
Location
Durham, NC, US
Posted
May 20, 2019
Ref
2019-3062
Hotbed
Bio NC
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 (ZOLGENSMA®). 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.

Responsible for managing the GxP Document Control System ensuring compliance to quality objectives and regulatory requirements. The successful candidate is a quality focused individual who will work closely with SMEs to execute workflows and business processes that align with best practices. AveXis is searching for candidates who have the ability to be impactful and efficient.

Responsibilities

  • Manage the preparation, routing, review, approval, distribution, and archival of new and revised controlled/managed documents.
  • Review documents submitted to ensure the correct use of templates, correctly entered metadata and document types.
  • Perform advanced word processing and assists AveXis personnel in resolving document format issues.
  • Ensure controlled documents are periodically reviewed for relevance and accuracy to ensure actual practices are reflected as defined in applicable procedure.
  • Provides guidance and advice on approved procedures, standardization and requirements associated with the document management system.
  • Collaborates with cross-functional departments to ensure timely implementation of document change requests.
  • Provides training to new staff on document management system and document management processes and procedures.
  • Support audits (internal & external) in order to verify that regulatory and quality requirements have been met.
  • Organizes and ensures accurate and reliable filing systems for all paper-based GxP documents.
  • Maintain SOP binders.
  • Perform other duties as required.


Qualifications

  • Minimum of 5 years of technical writing/document control experience in the pharmaceutical/biotech industry.
  • Works under minimal supervision; requires a high level of independence.
  • Bachelor's degree or equivalent combination of related education and experience.
  • Excellent knowledge of understanding of applicable GxP regulations.
  • Experience with Electronic Document Management Systems and is proficient with the Microsoft Office suite (ie, Word, Excel, Visio, PowerPoint, etc.) and Adobe.
  • Demonstrates ability to perform detail-oriented work with a high degree of accuracy.
  • Effective written and oral communication skills.
  • Effective time management and interpersonal skills.
  • Possesses initiative and is proactive.


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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