Quality Control Analyst

Job Discription:

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 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.

QCII
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 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