Quality Control Specialist - PCR Lab

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 provides expertise at the AveXis cGMP Manufacturing facility to include technical writing, routine testing, and all other associated activities. The QC 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 cGMP requirements, a basic understanding of FDA/EMEA regulations, effective interactions/communication with Quality management, and personal development. The QC Specialist may also support the Manager for activities related to training of employees, compliance with cGMP, and identifying and implementing corrective and preventive actions. The QC Specialist should be able to work effectively within the group, within Quality, and across the network.

Responsibilities

• Perform Biochemistry-based testing.
• Serve as subject matter expert in this area representing Quality Control during audits and inspections.
• Review and trend data and publish quarterly and annual trend reports.
• 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.
• 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.