
Senior Scientific Specialist
1 week ago
Scientific Laboratory Analyst
About the Role:This is a critical position supporting microbiological testing in Dublin, focusing on Environmental Monitoring, Water sampling, TOC, Bioburden, and Endotoxin.
Main Responsibilities:- Conduct environmental and facilities monitoring sampling and testing
- Support release and stability programs through on-site testing
- Maintain high standards of cGMP, GLP while adhering to schedules and targets for regulatory and business requirements
- Promote laboratory efficiency by completing project work and implementing initiatives
- Provide regular updates to management on laboratory issues
- Analyze out-of-specification/limit results using Structured Problem Solving, Root Cause Analysis, collaborating with the Microbiology Laboratory Supervisor, QA, and other departments, and implement corrective actions
- Develop and contribute to training/re-training programs for laboratory personnel
- Minimum 1 year experience in a Quality Assurance environment under cGMP regulations
- Background in testing sterile/non-sterile pharmaceutical/biopharmaceutical products
- Knowledge of current regulatory requirements for Microbiology / Sterility Assurance supporting cGMP operations
- Degree in Microbiology or related science
The duties are typically performed in a lab setting. Candidates must be able to lift/carry 15/30 pounds, work comfortably in controlled environments with biological, infectious, and hazardous materials, gown/degown PPE, use a computer, communicate via phone, video, and electronic messaging, and collaborate effectively.
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