Quality Control Specialist (PCR) - 2nd Shift

Employer
AveXis Inc.
Location
Durham, NC, US
Posted
Sep 25, 2019
Ref
2019-4215
Hotbed
Bio NC
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.

The Quality Control Specialist (PCR) provides expertise at the AveXis GMP Manufacturing facility. This includes technical writing, routine testing, and all other associated activities. The Specialist responsibilities include, but are not limited to, training, sampling, routine testing, method qualification/validations, investigations, and technical writing. A potential candidate will possess a strong understanding of QC testing techniques. Additional responsibilities include adherence to all GMP requirements, a thorough understanding of FDA/EMEA regulations, effective interactions/communication with Quality management, and personal development. The Specialist may also support the Manager for activities related to interviewing and training of employees, compliance with GMP, and identifying and implementing corrective and preventive actions. The Specialist should be able to work effectively within the group, within Quality, and across site.

Responsibilities

  • Perform established analytical methods such as ddPCR (Digital PCR) and qPCR (Quantitative PCR) for in-process, release, or stability samples.
  • Serve as subject matter expert for multiple assays representing Quality Control during audits and inspections.
  • Perform data review, trending and data analysis.
  • Conduct thorough investigations to determine root cause of OOS investigations and other non-conforming results and implement appropriate corrective and preventative actions in a timely manner.
  • Liaise with other departments including Quality Assurance, Manufacturing and Facilities to address compliance issues and to implement corrective actions and to improve programs.
  • Participate in assay troubleshooting, qualification and validation.
  • Manage the use and maintenance of scientific equipment and instrumentation, computer systems.
  • Write and revise documents such as SOPs and technical reports.


Qualifications

  • Minimum B.A. or B.S. in scientific related field.
  • Minimum of 5 years in a GMP Quality Control laboratory.
  • Strong knowledge of multiple assays.
  • Strong experience with method validation and qualification.
  • Experience leading small teams and projects.
  • Thorough understanding of Root Cause Analysis
  • 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.
  • Ability to work rotating shift
  • Ability to work overnight shift


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.