Novartis Microbiology QC Analyst Vacancy – Apply Online

Novartis Microbiology QC Analyst Vacancy – Apply Online

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

Job Title: Analyst, Quality Control – Microbiology

Job Locations US-NC-Durham

Job ID 2022-6800 # of Openings 1

Category Quality


  • B.A. or B.S. Microbiology or in scientific related field.
  • 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.


  • 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.

Novartis Microbiology QC Analyst

Apply Online


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