Quality Assurance Associate, Microbiology/Environmental Monitoring

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.

Quality Assurance monitors and verifies that the processes used to manage and create deliverables have been followed and are operative. Quality assurance for Microbiology/Environmental Monitoring (Micro/EM) provides the necessary quality oversight of Microbiology/EM functions to ensure compliance with all standards, procedures and specifications.

Responsibilities

• Provide quality assurance oversight and independent review for Micro/EM activities including review/approval of test records, testing and stability protocols and reports, and documentation supporting product disposition (i.e. certificates of testing, certificates of analysis, protocols).
• Provide quality assurance oversight for Micro/EM compliance including standard operating procedures, non-conformances, laboratory investigations, corrective/preventive actions, change controls, and invalid/aborted assays.
• Support activities associated with event resolution and CAPAs.
• Implement and ensure adherence of appropriate regulations and quality standards relative to Micro/EM.
• Write, review and approve Standard Operating Procedures (SOPs), Quality Impact and Risk Assessments (QRAs), Quality Plans, and specifications, as needed.
• Support the training program for Micro/EM analysts for lab specific quality systems and compliance (e.g. QA review and approval of training plans).
• Perform or support any other tasks necessary to maintain the product quality and site cGMP compliance.

Qualifications

• BS in Pharmacy, Microbiology, Biology or another science/engineering-based field with 1-year QA related experience and 2-3 years' experience in Micro/EM lab.
• Related experience should be in GMP regulated industries in quality assurance and/or compliance or equivalent. Related experience in supporting an operational quality control lab.
• Working knowledge of regulatory (e.g. FDA, EMEA) requirements, as well as industry quality management tools, standards, and quality systems.
• Understanding of pharmaceutical industry and cGMP experience is required, with knowledge and understanding of manufacturing, quality control, and validation requirements and activities.
• Works precisely according to procedures, rules and regulations. Has a passion for continuous improvement and quality.
• Demonstrates the highest ethical standards. Actively promotes trust, respect and integrity in all dealings both inside and outside the Company.

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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