Internship, Quality Assurance

Location
Libertyville, IL
Posted
Jan 13, 2022
Ref
2022-6519
Hotbed
BioMidwest
Required Education
Bachelors Degree
Position Type
Full time

Imagine… 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 Therapy are laser focused on bringing hope and possibility to those devastated by rare genetic diseases.

 

The Quality Assurance intern, is responsible for supporting the implementation and maintaining robust Quality Systems for a gene therapy manufacturing site.

Responsibilities

  • Strategic compliance to written procedures including but not limited to: regulatory adherence and audit support, raw material qualification, specifications, supplier management, internal assessment processes, incoming release of materials and monitoring compliance with all requirements of good manufacturing practice.
  • SOPs/Document Management: Support all instruction sets, specifications, instructions and other Quality Assurance procedures directly related to incoming quality /operations and other cGMP activities.
  • Deviation/CAPA Management: Ensure all deviations from established procedures are appropriately documented and investigated to determine and fix root cause.
  • Manage Change Records for incoming raw materials and drive them to completion.
  • Vendor Management/Raw Material Release: Support all required assessments are carried out to support Quality approval or rejection, as appropriate, for starting materials, packaging materials, intermediates, bulk and finished product.
  • Support the handling of supplier complaints at the site level.
  • Participate in self inspection program for the manufacturing facility. Manage findings, responses and corrections.
  • Ensures data integrity review of electronic raw data against the reported data as needed to support raw material releases.
  • Participate in site inspection preparation and response process for regulatory agencies.
  • Other related duties as assigned.

Qualifications

  • Student B.S., preferably in microbiology, chemistry, biochemistry or engineering.
  • 2 years' experience in biopharmaceutical based GMP manufacturing operations is preferred.
  • Completed at least two years of college education before beginning the internship.
  • Must be enrolled in school the semester following the internship.
  • Quality experience is desired.
  • Experience with viral gene therapies and/or orphan disease indications is a plus.
  • Knowledge of FDA and EU regulations and experience in US and international regulatory agency inspections.
  • Strong knowledge and application of the CFRs and cGMPs, experience with regulatory inspections, self-inspections, and external audits is a plus.
  • Experience reviewing and/or authoring standard operating procedures and partnering with operations on product related investigations and deviations are a plus.
  • Excellent oral and written communication skills with strong technical writing experience required.
  • Ability to synthesize data and summarize outcomes to provide recommendations on compliant path forward.

 

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!

 

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.

 

Accessibility and reasonable accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to tas.nacomms@novartis.com call +1 (877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

 

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