Quality Control Specialist - Incoming QC

Employer
AveXis Inc.
Location
Durham, NC, US
Posted
Jun 12, 2019
Ref
2019-3778
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.

AveXis is seeking a highly motivated and solution-driven individual to join the dynamic and growing Quality Control (QC) team in Durham, NC. The individual will be responsible for sampling of incoming raw materials and performing associated release activities. The QC Analyst is responsible for routine sample testing under GMP mode, laboratory maintenance, and participating in method qualification/verification.

A potential candidate should be able to practice proper analytical techniques. The candidate should be able to adhere to all GMP requirements, FDA/EMEA regulations, and have effective interactions/communication with Quality management. The QC Analyst may also support the identification and implementation of corrective and preventive actions. He/she should be able to work effectively within the group, within Quality, and across the site.

Responsibilities

  • Serve as SME for incoming raw material testing
  • Perform routine QC testing using the following analytical methods:
    • FTIR
    • Physical testing (pH, appearance, osmolality, conductivity, sub-visible particulates)


  • Participate in method troubleshooting, qualification and validation if needed.
  • Manage the procurement, implementation, use, and maintenance of scientific equipment, instrumentation, and computer systems.
  • Write and revise documents such as SOPs, specifications and technical reports.
  • Lead investigations to determine root cause of deviations and non-conforming results and implement appropriate corrective and preventative actions in a timely manner.
  • Identify and implement new technologies to improve the compliance and efficiency of QC operations.
  • Represent QC to work with other departments including Analytical Development, Quality Assurance, and Manufacturing to address compliance issues and to implement corrective actions and to improve programs.
  • Perform other related duties as assigned.


Qualifications

  • Minimum B.A. or B.S. in scientific related field.
  • Minimum of 5 years in a GMP Quality Control laboratory.
  • Working knowledge of multiple assays.
  • Experience with method validation and qualification.
  • Experience leading small teams and projects.
  • Self-reliant, a good problem solver and results-oriented, and comfortable working in a fast-paced environment.
  • An excellent and persuasive communicator.
  • Energetic, flexible, collaborative and 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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