A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post: Analyst I, QC (Microbiology)
Job Description:
Perform facility validation testing and routine EM and clean Utility testing. Will require weekends and overtime.
Operational Phase: Participate in the proper and timely execution of testing activities in the production areas and laboratories. Issue excursion notices and assist in investigating root causes. Provide technical expertise and on the floor mentoring for gowning, disinfection and aseptic technique to manufacturing group. Required to work weekends as necessary.
Major Accountabilities:
Environmental Monitoring and Utility Monitoring programs
Perform bioburden, TOC, conductivity, pH, appearance, endotoxin testing for facility water as required
Perform sampling of site compressed gasses
Issue excursion notices and assist in investigating root causes.
Peer review data
Maintain GMP compliance and documentation
Maintain compliance with legal regulations on occupational safety and health, particularly with regard to hazardous materials.
Comply with laboratory policies and procedures
Participate in lean lab operation, 5S laboratory layout, preventive action & continuous improvement programs to reduce operating costs
Assist in special projects and investigations
Candidate Profile:
BS degree in life science with 0-2 years directly related laboratory experience or equivalent education experience combination.
Basic knowledge of microbiology methods and instruments, as apply to aseptic processing. Including validation experience.
Intermediate knowledge of GMPs, safety regulations and data integrity
Ability to work flexible hours, including evenings and weekends.
Ability to travel (domestic and international) is essential.
Additional Information:
Location: Holly Springs, NC
Education: BS
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Production
Division: Vaccines & Diagnostics
Job Type: Full Time
Employment Type: Permanent
Job ID: 95050BR
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