Quality Control Sample Coordinator

Location
Libertyville, IL, US
Posted
Oct 06, 2020
Ref
5650
Hotbed
BioMidwest
Required Education
Associate Degree
Position Type
Full time
Overview

Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? Since 2013, Novartis Gene Therapies (formerly AveXis) has had one focus: bringing change to those devastated by genetic diseases.

The Novartis Gene Therapies culture embraces this mission. As a compassionate and dedicated team, we are enthusiastic about the science behind our work and finding answers to difficult questions. We are dedicated to communities affected by rare diseases, and these patients and families are the motivation for everything we do.

We have built a team with exceptional depth of experience, unified by a common vision; to develop gene therapies with the potential to positively impact the lives of the patients and families devastated by rare and life-threatening neurological genetic diseases. Though we are proud of what we have achieved to date, we remain relentlessly focused on making that vision a reality.

The QC Sample Coordinator provides sample control support in GMP and non-GMP 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 the site.

Responsibilities
  • Create sample tracking and inventory system to track development samples
  • Generate sample submission forms for various testing facilities
  • Collect sample forecasts to ensure lead time notice
  • Confirm testing was complete when sample invoices arrive
  • Follow/track international shipments, and alert logistics group of any customs clearance issues
  • Inspect incoming sample shipments 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 logbooks
  • Draft sample management procedures
  • Communicate with other departments including Quality Assurance, Manufacturing and Facilities to address compliance issues and to implement corrective actions and to improve programs.
  • Write and revise documents such as SOPs and technical reports.

Qualifications
  • Minimum Associates Degree in scientific field, B.A. or B.S. in microbiology or related scientific field preferred
  • Minimum of 2 years of related experience in a GMP Quality Control laboratory.
  • 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.

Novartis Gene Therapies 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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