Microbiology Specialist
Novartis
12 hours ago
On-site
Durham, NC
Operations
Key responsibilities:
- Perform microbiological qualification, release, stability, and investigational testing to support compliant manufacturing operations.
- Author and maintain protocols and reports for microbiology and environmental monitoring method verification and validation.
- Execute method transfers and verifications for microbiology and environmental monitoring assays across laboratory systems.
- Maintain qualification, control, and trending of critical reagents, standards, and microbiology controls.
- Review and approve routine and transfer data, supporting deviations, change controls, and quality investigations.
- Coordinate environmental monitoring performance qualification, site assessments, media fills, and utilities qualification.
- Perform microbiological testing of materials, utilities, and environmental and personnel monitoring samples.
- Analyze trends and performance indicators while supporting sample planning and execution.
Essential requirements:
- Bachelor’s degree in biochemistry, biology, microbiology, or a related scientific discipline.
- Minimum five years of experience in a Good Manufacturing Practice (GMP) environment.
- Proven experience performing microbiological testing (utilities testing; environmental and personnel monitoring).
- Demonstrated ability to write protocols, verification documentation, and technical reports using Good Documentation Practice.
- Experience reviewing and approving laboratory data supporting deviations, investigations, and change controls.
- Strong knowledge of Good Laboratory Practice (GLP) and Good Documentation Practice (GDP).
- Understanding of U.S. FDA and European Medicines Agency regulatory expectations.
- Ability to gown for aseptic areas and lift ~25 pounds.
- Perform microbiological qualification, release, stability, and investigational testing to support compliant manufacturing operations.
- Author and maintain protocols and reports for microbiology and environmental monitoring method verification and validation.
- Execute method transfers and verifications for microbiology and environmental monitoring assays across laboratory systems.
- Maintain qualification, control, and trending of critical reagents, standards, and microbiology controls.
- Review and approve routine and transfer data, supporting deviations, change controls, and quality investigations.
- Coordinate environmental monitoring performance qualification, site assessments, media fills, and utilities qualification.
- Perform microbiological testing of materials, utilities, and environmental and personnel monitoring samples.
- Analyze trends and performance indicators while supporting sample planning and execution.
Essential requirements:
- Bachelor’s degree in biochemistry, biology, microbiology, or a related scientific discipline.
- Minimum five years of experience in a Good Manufacturing Practice (GMP) environment.
- Proven experience performing microbiological testing (utilities testing; environmental and personnel monitoring).
- Demonstrated ability to write protocols, verification documentation, and technical reports using Good Documentation Practice.
- Experience reviewing and approving laboratory data supporting deviations, investigations, and change controls.
- Strong knowledge of Good Laboratory Practice (GLP) and Good Documentation Practice (GDP).
- Understanding of U.S. FDA and European Medicines Agency regulatory expectations.
- Ability to gown for aseptic areas and lift ~25 pounds.