Quality Control Senior Investigations 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.

As part of the Quality Control organization, the Quality Control (QC) Investigations Sr. Specialist will be responsible for the investigation and completion of laboratory investigations and non-conformances aimed at identification of root cause, assessing potential impact and implementation of corrective and preventive actions. The QC Investigations Specialist will help determine the validity of data, and determination of out of specification results. The successful candidate will work in a cGLP environment and must have a working knowledge of biopharmaceutical QC testing operations, 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 while performing investigations. Must have the ability to understand and problem solve in an environment that is focused heavily on bioassays, PCR, and microbiological assays. The successful candidate will understand the concepts incorporated in Quality Assurance in a GMP environment. Skills in statistics are required to effectively analyze trends.

Responsibilities

• Authoring of minor and major laboratory investigation reports and non-conformances related to QC testing.
• Work in the QC laboratories in order to gather data, observe testing for investigations, and interview employees.
• Conduct personnel interviews and testing reviews; act as an unbiased investigator with questions surrounding the specific issue.
• Perform appropriate root-cause analysis for events utilizing investigation tools (e.g., 5 Whys, Fishbone Diagrams).
• Assign and implement proper corrective action and preventive action (CAPA) to resolve and prevent recurrence of events.
• Facilitate and participate in meetings, aligning internal review team and area subject matter experts on an agreed to investigational path forward.
• Conflict resolution, problem solving in a cross functional setting, and ability to meet timelines for closure of exception events.
• Remain current in regulatory expectations and industry practices regarding investigations, change controls and CAPAs.
• Management of multiple projects and timelines concurrently.
• Ability to adhere to standard timeline and escalate actions appropriately for resolution in a timely manner.
• Initiate, own, and drive change controls related to QC operations.
• Utilize appropriate risk management tools for recommendation on disposition of test data.
• Assist in the data collection from QC and preparation of necessary documentation to support Annual Product Reviews.
• Technical writing to support QC operations including but not limited to, Standard Operating Procedures (SOP), Test methods, change controls, training documentations, protocols, and white papers.

Qualifications

• Bachelor of Arts/Science or equivalent combination of education with minimum relevant experience.
• At least 8 years of prior experience in a GMP environment.
• Preferred 3+ years of prior experience in Quality.
• Prior experience with quality investigations and deviation writing in a QC/Quality environment preferred.
• QC experience in a GLP environment is preferred.
• Must have the ability to work in a fast paced, high workload environment, and be able to manage multiple projects and objectives for on-time event closure.
• 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 a 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.

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. #LI-MG1