Quality Control Planner (Biochemistry)

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 (QC) Group is part of the Quality organization and is responsible for testing of raw materials, in-process, release, and stability samples. The Planner will be primarily responsible for coordinating, developing, and managing QC schedules on a daily basis with real time updates of routine and non-routine activities to increase efficiency and productivity. Additionally, the Planner will be responsible to develop effective scheduling process to achieve testing objectives.

The successful candidate will work in a cGLP environment and must have working knowledge of a QC environment, the ability to manage multiple ongoing projects concurrently, have strong meeting facilitation and conflict resolution skills, a strong technical writing capability, be action oriented and compliant minded. Skills in statistics required to effectively analyze trends is also desired.

Responsibilities

• Coordinate, develop, and manage QC schedules daily with ability for real time updates of routine and non-routine activities to increase efficiency and productivity.
• Develop effective scheduling process to achieve testing objectives.
• Analyze and address testing issues related to scheduling in real time.
• Oversee routine equipment maintenances to avoid outages and repairs during testing.
• Manage testing schedule to accommodate maintenance activities and non-routine requests.
• Organize job trainings for staff to meet testing goals and objectives.
• Update testing training materials.
• Conflict resolution, problem solving in a cross functional setting, and ability to meet testing timelines.
• Ability to adhere to standard timeline and escalate actions appropriately for resolution in a timely manner.
• Support strategic proposals, progress updates and presentations to all levels of the site organization.

Qualifications

• Bachelor of Arts/Science or equivalent combination of education with strong and broad relevant experience.
• Prior experience scheduling testing in a GLP environment is required.
• Experience with scheduling tools that could be used for real time updates to a testing schedule is required.
• Experience in laboratory bench work strongly desired.
• Must work well on a team and be able to trouble shoot and problem solve in a cross functional team setting.
• Must be proactive, action oriented, and have the ability to adapt to change.
• Must be able to identify and flag risks in a timely manner to keep deliverables on track.
• Must have strong communication skills both verbally and written.
• Must have proven logic and decision-making abilities, critical thinking skills.
• Must be able to accommodate testing schedule as required.
• Must have strong Microsoft Office Suite (Word, Excel, and PowerPoint) skills.
• Six Sigma Yellow, Green or Black Belt certification is preferred.

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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