**
**
**POSITION SUMMARY:
**
**The Quality Control Analyst I **for the QC Microbiology Department will be responsible for performing processing of routine environmental monitoring samples, product-release testing, and raw material testing. The position requires the utmost attention to detail, good organizational skills, computer proficiency, and a basic understanding of microbiology and laboratory instrumentation. In addition, effective communication skills and the ability to function in a fast-paced, highly technical environment with minimal supervision are essential for success.
**ESSENTIAL DUTIES AND RESPONSIBILITIES:
**• Performs environmental monitoring, including air viable particulate, non-viable particulate and surface sampling and personnel monitoring
• Receives raw materials and supplies for the QC laboratory and maintains laboratory supplies, media and reagents inventory
• Adheres to standard operating procedures and good documentation practices to ensure data integrity and traceability
• Participates with maintaining proper overall operation of department (physical inventories, logs, documentation, filing, etc.)
• Responsible for assisting with routine laboratory upkeep and organization
• Utilizes GMP systems such as MODA and other laboratory computer systems
• Reviews test results of other QC analysts for accuracy and precision and maintains and efficient workflow of all required testing documentation ensuring timely submission relative to product release dates
• Perform all other related duties as assigned.
The Quality Control Analyst II for the QC Microbiology Department will be responsible for performing routine environmental monitoring, product testing, and raw material testing. The position requires the utmost attention to detail, very strong organizational skills, computer proficiency, and a basic understanding of microbiology and laboratory instrumentation. In addition, effective communication skills and the ability to function in a fast-paced, highly technical environment with minimal supervision are essential for success.**
**
**ESSENTIAL DUTIES AND RESPONSIBILITIES:
**• Performs sterility testing and endotoxin testing of raw materials, in-process samples and finished products
• Performs growth promotion of microbial media
• Performs environmental monitoring, including air viable particulate, non-viable particulate and surface sampling and personnel monitoring
• Prepares environmental monitoring excursion reports and conducts minor laboratory investigations.
• Receives raw materials and supplies for the QC laboratory and maintains laboratory supplies, media and reagents inventory
• Adheres to standard operating procedures and good documentation practices to ensure data integrity and traceability
• Assists the QC Supervisor/Leads with managing proper overall operation of department (physical inventories, logs, documentation, filing, etc.)
• Maintains familiarity with QC-relevant current Good Manufacturing Practices (cGMP) guidance (CFR, USP, EP, ICH, etc.)
• Responsible for assisting with routine laboratory upkeep and organization
• Reviews test results of other QC analysts for accuracy and precision and maintains and efficient workflow of all required testing documentation ensuring timely submission relative to product release dates
• Perform other related duties as assigned