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Microbiology Quality Assurance Technician
2 months ago
Microbiology Quality Assurance Technician:
We are seeking a detail-oriented professional to join our team as a Microbiology Quality Assurance Technician. This role is crucial in ensuring the integrity and compliance of our laboratory processes.
Key Qualifications:
- Demonstrated experience in microbiological testing, including bacterial endotoxin testing and environmental monitoring.
- Familiarity with quality management systems such as GMP and ISO 13485.
- Strong attention to detail and analytical skills.
Educational Background:
A minimum of a High School Diploma is required, with a preference for candidates holding an Associate's Degree in Science or Microbiology.
Experience Requirements:
At least 2 years of relevant experience in a laboratory setting.
Responsibilities:
- Conduct bacterial endotoxin testing utilizing kinetic turbidimetric methods.
- Coordinate microbiological analyses with external laboratories to ensure timely results.
- Perform environmental monitoring in cleanroom settings, focusing on both viable and non-viable particles.
- Adhere to the laboratory testing schedule, ensuring prompt delivery of results while tracking and trending data.
- Review microbiological test outcomes, escalate any discrepancies, and conduct thorough investigations.
- Source necessary materials and equipment from various internal and external resources.
- Execute a range of technical procedures, including the preparation of routine solutions and reagents.
- Document observations, perform basic calculations, and compile data for analysis.
- Support laboratory operations by managing supplies, equipment, and glassware.
- Maintain compliance with company and regulatory standards to uphold quality and accuracy.
- May involve analysis of compounds and management of the corporate compound collection.
- Engage in technical procedures across various domains such as Production, Research and Development, Quality Control/Assurance, and Compliance/Environmental.
Essential Skills:
- Proficiency in Bacterial Endotoxin Testing.
- Experience with Bioburden Analysis.
- Utilization of relevant microbiological laboratory expertise.
Preferred Skills:
- Knowledge of Aseptic Techniques.
- Experience with CEA Environmental Monitoring.
