Specialist, Quality Control Microbiology (FIRST SHIFT ; WEDNESDAY - SATURDAY 4X10)

Location
Durham, NC
Posted
Apr 18, 2022
Ref
2022-6593
Hotbed
Bio NC
Required Education
Bachelors Degree
Position Type
Full time

magine… 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.

 

We use cutting-edge technology to turn promising gene therapies into proven treatments beginning with SMA but also focusing on Rett Syndrome and Friedreich's Ataxia. Imagine the lives you could transform by joining the Novartis Gene Therapy team. 

 

The Specialist, Quality Control Microbiology, provides Environmental Monitoring/Microbiological support at a GMP Manufacturing facility.

Responsibilities

  • FIRST SHIFT; WEDNESDAY TO SATURDAY; WORK SCHEDULE is 4 Days X 10 work hours per day
  • Training, data review, routine testing, method qualification/validations, investigations, and technical writing.

  • Performs Cell Culture Assays, Environmental Monitoring, and Microbiological testing.   

  • Reviews and trends data and publish quarterly and annual trend reports.  

  • Conducts thorough investigations to determine root cause of OOS investigations and other non-conforming results and implement appropriate corrective and preventative actions in a timely manner.  

  • Liaise with other departments including Quality Assurance, Manufacturing, and Facilities to address compliance issues, implement corrective actions and improve programs.  

  • Participates in assay troubleshooting, qualification, and validation.  

  • Manages the use and maintenance of scientific equipment, instrumentation and computer systems.  

  • Writes and revises documents such as SOPs and technical reports.  

  • Other related job duties as assigned.

Qualifications

  • B.A. or B.S. Microbiology or in scientific related field and 5 years in a GMP Quality Control Microbiology/ Environmental Monitoring laboratories, preferably in a biologics aseptic processing facility. 

  • Strong technical understanding of QC Microbiological/Cell Culture/Environmental Monitoring testing techniques.

  • Ability to work effectively within the group, within Quality, and cross functionally.

  • Strong knowledge of Environmental Monitoring and Microbiological Assays (e.g. Bioburden, Endotoxin, Gram Stain, Microbial ID, and Sterility). 

  • Ability to gown for entry into Aseptic core and supporting areas, and lift approximately 25 lbs. 

  • Experience with method and instrument qualification. 

  • Experience performing laboratory investigations and environmental monitoring excursion investigations. 

  • Experience with classroom and on the job training (i.e. Microbiological Assays, Aseptic Techniques, and Aseptic Gowning). 

  • Good understanding and demonstration of aseptic techniques. 

  • Experience leading small teams and projects. 

  • Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211/1271, ISO 14644-1, USP, EP, JP). 

  • Proficient in MS Word, Excel, Power Point and other applications. 

  • Ability to communicate and work in a team environment. 

  • Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities. 

  • Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description. 

  • Ability to think critically, and demonstrate troubleshooting, and problem-solving skills. 

  • Excellent interpersonal, verbal and written communication skills. 

   

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

Need help finding the right job?

We can recommend jobs specifically for you! Click here to get started.