Analyst, Quality Control Microbiology (Sunday - Wednesday; Day Shift)

Location
Durham, NC
Posted
May 08, 2022
Ref
2022-6623
Hotbed
Bio NC
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 Therapies are laser focused on bringing hope and possibility to those devastated by rare genetic diseases.

 

The Analyst, Quality Control - Microbiology performs Environmental Monitoring and Microbiological testing in support of manufacturing at the assigned GMP Manufacturing facility.

Responsibilities

 
  • Performs environmental and utilities monitoring in clean rooms.
  • Conducts routine product and raw material testing, environmental monitoring of the manufacturing cleanrooms and processes, participate in method and instrument qualifications, and support investigative testing.  
  • Performs bioburden, endotoxin and cell culture assays.
  • Performs data entry.
  • Assists in drafting and revising SOPs and reports.
  • Trends EM data and publish quarterly and annual trend reports.
  • Assists 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.
  • Establishes and maintains library of environmental isolates.
  • Assists in assay troubleshooting, qualification and validation.
  • Manages the use and maintenance of scientific equipment and instrumentation, computer systems;
  • Other related duties as assigned.

 

Requirements:

  •  

Qualifications

  • B.A. or B.S. Microbiology or in scientific related field and 2 years in a GMP Quality Control Microbiology/ Environmental Monitoring laboratories, preferably in a biologics aseptic processing facility.
  • Possess work 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.
  • Working knowledge of Environmental Monitoring and Microbiological Assays (e.g. Bioburden, Endotoxin, Gram Stain, and Sterility).
  • Good understanding and demonstration of aseptic techniques.
  • Ability to gown for entry into Aseptic core and supporting areas, and lift approximately 25 lbs.
  • 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.

 

While Novartis does not require vaccination at this time, for certain Novartis sites in the US all associates and candidates may be required to either upload an image of their COVID-19 vaccine card demonstrating proof of full vaccination for COVID-19 (or other similar evidence of vaccination) or proof of a negative COVID-19 test taken by the associate or candidate within the past seven days to enter any of our sites and/or customer office or healthcare facility, as well as prior to participating in other work related off-site meetings. Employees working in customer-facing roles must adhere to and comply with customers' (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send accommodation requests to Eh.occupationalhealth@novartis.com

 

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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