Senior Coordinator, Quality Control Sample

Location
Durham, NC, US
Posted
Jul 18, 2021
Ref
6111
Hotbed
Bio NC
Required Education
Bachelors Degree
Position Type
Full time
Overview

Imagine\u2026 2 weeks after the birth of your child you realize they aren't meeting critical developmental milestones and after months of doctor's appointments you are told your baby has a rare neurological disease that would impact how they would live their lives. This is the reality of parents whose children have Spinal Muscular Atrophy (SMA) and it's the reason why we at Novartis Gene Therapies are laser focused on bringing hope and possibility to those devastated by rare genetic diseases.

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 Senior Coordinator, Quality Control Sample, Quality Control Sample, leads sample control support at the assigned site/laboratory.

Responsibilities

Monday to Friday, Day Shift; occasional weekends
  • Oversight of QC in-process, release, raw material, and stability, and development samples, associated document management, and collection of data.
  • Adherence to all GMP requirements, a proficiency in understanding of FDA/EMEA regulations, effective interactions/communication with Quality management, personal development, and support of investigations and inspections/audits.
  • Manage sample tracking and the inventory system to track commercial and development samples.
  • Generate sample submission forms for various testing facilities and process returned results.
  • 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.
  • Execute protocols to support network stability, qualified material programs and pipeline product studies.
  • Create and continuously improve sample management procedures and processes.
  • Communicate with other departments and sites 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.
  • May support the Manager for activities related to training of employees, coordination of tasks, compliance with GMP, and identifying and implementing corrective and preventive actions.
  • Other related job duties as assigned.

Qualifications
  • High School degree with 6 years related experience in a GMP Quality Control Laboratory or Associate's degree with 4 years related experience in a GMP Quality Control Laboratory or Preferred, Bachelors' degree in a relevant scientific concentration plus 2 years related experience in a GMP Quality Control Laboratory.
  • Possess a strong understanding of the requirements of sample receipt and inventory management in a GMP laboratory.
  • Excellent oral and written communication skills with strong technical writing experience required.
  • Able to work independently and effectively within the group, within Quality, and across the site.
  • Ability to work in both paper based and electronic laboratory information management systems.

The level of this position will be based on the final candidate's qualifications.

Why Novartis?

769 million lives were touched by Novartis medicines in 2020, and while we're proud of this, we know there is so much more we could do to help improve and extend people's lives. We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis!

Novartis Gene Therapies Benefit Summary:

Annual bonus, long term incentive, health insurance, paid vacation/holidays, potential flexible working arrangements (based on role) and an employee recognition program are available for this position, among many other benefits provided to employees of Novartis Gene Therapies.

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. #LI-MG1