Quality Control Sample Coordinator
Company: AveXis Inc.
Posted on: June 15, 2019
OverviewReady 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 Sample Coordinator provides sample control support at a
Manufacturing facility. This includes the administration of QC
in-process, release, and stability samples, associated document
coordination, and collection of data. A potential candidate will
possess an understanding of the requirements of Sample Coordination
in a GMP laboratory. Additional responsibilities include adherence
to all GMP requirements, a basic understanding of FDA/EMEA
regulations, effective interactions/communication with Quality
management, personal development, and support of investigations.
The QC Sample Coordinator may also support the Manager for
activities related to training of employees, compliance with GMP,
and identifying and implementing corrective and preventive actions.
The QC Sample Coordinator should be able to work effectively within
the group, within Quality, and across site.Responsibilities
- Usher Quality Control samples through the entire sample
lifecycle maintaining sample integrity and chain of custody.
- Generate sample submission forms for various testing
- Collect sample forecasts to ensure lead time notice.
- Confirm testing was complete when sample invoices arrive.
- Follow/track shipments and help resolve shipping issues.
- Log, receive, and aliquot incoming samples and take necessary
actions if samples do not comply with SOPs.
- Review and evaluate temperature data reports from temperature
monitoring devices included with sample shipments.
- Create equipment, inventory, and sample receipt and tracking
- Draft sample management procedures.
- Liaise with other departments including Quality Assurance,
Manufacturing, Facilities, Supply Chain, and Warehouse to address
compliance issues and to implement corrective actions and to
- Write and revise documents such as SOPs and technical
- Equipment preventative maintenance.
- Perform other duties as assigned. Qualifications
- Minimum B.A. or B.S. in a scientific field OR A.A or A.S. plus
2 years related experience in a GMP Quality Control Laboratory OR 4
years related experience in a GMP Quality Control Laboratory.
- Ability to lift approximately 25 pounds.
- Proficient in Microsoft Word, Excel, Power Point and other
- Ability to communicate and work in a team environment.
- Comfortable in a fast-paced small company environment with
proven ability to adjust workload based upon changing
- Self-motivated, detail-oriented, and willing to accept
temporary responsibilities outside of core duties.
- Ability to think critically and demonstrate troubleshooting and
- Excellent interpersonal, verbal and written communication
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-RL1
Keywords: AveXis Inc., Denver , Quality Control Sample Coordinator, Professions , Longmont, Colorado
Didn't find what you're looking for? Search again!