QC Analyst I – Microbiology

Job Description

QCI – Job 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.

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.

QCII – Job Summary:

• 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.

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.

Interview Process: Virtual interview for 45 minutes.