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Quality Control Analyst - Microbiology (FIRST SHIFT ; SUNDAY - WEDNESDAY)

Employer
Novartis Gene Therapies
Location
Durham, NC
Start date
Jan 13, 2022

View more

Discipline
Quality, Quality Control, Science/R&D, Microbiology
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Bio NC

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

 

The QC Microbiology Analyst performs Environmental Monitoring and Microbiological testing in support of manufacturing at the Novartis Gene Therapies GMP Manufacturing facility. The QC Microbiology Analyst responsibilities include, but are not limited to, routine product and raw material testing, environmental monitoring of the manufacturing cleanrooms and processes, participate in method and instrument qualifications, and support investigative testing.  A potential candidate will possess working knowledge of QC Microbiological/Cell Culture/Environmental Monitoring testing techniques.  The QC Analyst should be able to work effectively within the group, within Quality, and cross functionally.

Responsibilities

  • 4X10 Work Schedule
  • Perform environmental and utilities monitoring in clean rooms.
  • Perform bioburden, endotoxin and cell culture assays.
  • Perform data entry.
  • Assist in drafting and revising SOPs and reports.
  • Trend EM data and publish quarterly and annual trend reports.
  • Assist with investigations to determine root cause of environmental excursions and other non-conforming results and implement appropriate corrective and preventative actions in a timely manner.
  • Establish and maintain library of environmental isolates.
  • Assist in assay troubleshooting, qualification and validation.
  • Manage the use and maintenance of scientific equipment and instrumentation and computer systems.

Qualifications

  • Bachelor's degree in scientific disciplines such as Biochemistry, Biology, Microbiology or related field, or 4 years relevant experience in lieu of degree.
  • Learns to use professional concepts. Applies company policies and procedures to resolve routine issues.
  • ability to communicate and work in a team environment
  • Normally receives detailed instructions on all work

 

 

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.

 

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. #LI-MG1

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