Novartis Microbiology QC Analyst Vacancy – Apply Online
2 weeks after the birth of your child, imagine you realize they arenโt meeting critical developmental milestones and after months of doctorโs 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 itโs 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.
Job Title: Analyst, Quality Control – Microbiology
Job Locations US-NC-Durham
Job ID 2022-6800 # of Openings 1
Category Quality
Qualifications
- 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.
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.
Novartis Microbiology QC Analyst
