Specialist, Quality Control, Microbiology
Novartis
Quality Assurance
United States
Posted on May 3, 2025
Summary
This position will be located at Durham, NC and will not have the ability to be located remotely.
The Specialist, Quality Control, assists and supports the organization with initial compliance and ongoing preparation, testing and monitoring of conformance to established quality processes and standards for manufacturing and production. The Specialist, Quality Control - Microbiology performs Environmental Monitoring and Microbiological testing in support of manufacturing at the assigned GMP Manufacturing facility, data review and report writing.
#LI-Onsite
Key Responsibilities:
• Executes routine and non-routine analysis, may include, but not limited, to cGMP release and characterization testing using microbial techniques such as environmental and utilities monitoring in clean rooms, bioburden, endotoxin, growth promotion, sterility, and cell culture assays.
• Assists in the evaluation of internal controls, communications, risk assessments and maintenance of documentation as related to compliance with internal and external safety, quality, and regulatory standards.
• Reviews data obtained for compliance to specifications and reports abnormalities. Performs trend analysis of methods / environmental data / assay controls & standards and draws conclusions.
• Capable of delivering to assigned work schedule with attention to detail and accuracy.
• Ensure schedule adherence aligns with department goals and manufacturing support. Escalate as needed.
• Support department risk assessments and participates in audit walk-throughs.
• Compiles data for documentation of test procedures that may include stability program testing and formulation studies.
• Escalate issues with multiple solutions to management when timelines are at risk
• Supports Quality Control department at QMR by preparing slide deck and presenting laboratory metrics.
• Proficient in investigations, summaries and reports. Reviews data obtained for compliance to specifications and reports Investigates and resolves non-conforming test results by completing thorough Deviation, OOS/OOT/OOE and Investigation.
• Authors new/revise Standard Operating Procedures, Protocols / Summary Reports /Trend Reports for QC.
• Oversees special projects on microbial and instrument problem solving. May develop testing and analysis methods and procedures in accordance with established guidelines.
The Specialist, Quality Control, assists and supports the organization with initial compliance and ongoing preparation, testing and monitoring of conformance to established quality processes and standards for manufacturing and production. The Specialist, Quality Control - Microbiology performs Environmental Monitoring and Microbiological testing in support of manufacturing at the assigned GMP Manufacturing facility, data review and report writing.
#LI-Onsite
Key Responsibilities:
• Executes routine and non-routine analysis, may include, but not limited, to cGMP release and characterization testing using microbial techniques such as environmental and utilities monitoring in clean rooms, bioburden, endotoxin, growth promotion, sterility, and cell culture assays.
• Assists in the evaluation of internal controls, communications, risk assessments and maintenance of documentation as related to compliance with internal and external safety, quality, and regulatory standards.
• Reviews data obtained for compliance to specifications and reports abnormalities. Performs trend analysis of methods / environmental data / assay controls & standards and draws conclusions.
• Capable of delivering to assigned work schedule with attention to detail and accuracy.
• Ensure schedule adherence aligns with department goals and manufacturing support. Escalate as needed.
• Support department risk assessments and participates in audit walk-throughs.
• Compiles data for documentation of test procedures that may include stability program testing and formulation studies.
• Escalate issues with multiple solutions to management when timelines are at risk
• Supports Quality Control department at QMR by preparing slide deck and presenting laboratory metrics.
• Proficient in investigations, summaries and reports. Reviews data obtained for compliance to specifications and reports Investigates and resolves non-conforming test results by completing thorough Deviation, OOS/OOT/OOE and Investigation.
• Authors new/revise Standard Operating Procedures, Protocols / Summary Reports /Trend Reports for QC.
• Oversees special projects on microbial and instrument problem solving. May develop testing and analysis methods and procedures in accordance with established guidelines.