Quality Control Analyst (Documentation Specialist)

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.

AveXis is seeking a highly motivated and solution-driven individual to join the dynamic and growing Quality Control (QC) team. The QC Analyst (Documentation Specialist) is responsible for data entry, analytical data review, maintaining and storing routine documents, performing routine edits to controlled documents, and maintaining the data flow from QC to other departments across the company.

A potential candidate should have experience reviewing analytical documentation and data entry in a cGMP environment, in addition to experience with LIMS. The documentation specialist must be detail-oriented, highly organized, and able to work with a high volume of documents in a fast-paced environment. Additional responsibilities include adherence to all GMP and GDP requirements, a basic understanding of FDA/EMEA regulations, effective interactions/communication with Quality management and support of investigations. The QC Analyst may also support and identification and implementation of corrective and preventive actions. He/she should be able to work effectively within the group, within Quality, and across site. Additional experience in performing analytical techniques such as PCR, immunoassays, chromatography, AUC, and electrophoresis is preferred.

Responsibilities

• Perform review of in-process, release, or stability testing for established analytical methods such as PCR, immunoassays, chromatography, AUC, and electrophoresis to support QC operations.
• Data entry into local databases or LIMS.
• Write and revise documents such as SOPs and technical reports.
• Support investigations to determine root cause of deviations and non-conforming results and implement appropriate corrective and preventative actions in a timely manner.
• Liaise 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 required.

Qualifications

• Minimum B.A. or B.S. in biochemistry or related scientific field.
• Minimum of 1 year GMP lab experience and at least 2 years of industry experience.
• Excellent oral and written communication skills with strong technical writing experience required.

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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