Microbiology Technician

Job Description

Job Description

Salary : $20 / hr DOE

Position Summary :

Performs various microbiological sampling and testing in an FDA regulated environment, including personnel and environmental monitoring.

Essential Functions :

• Perform and review environmental monitoring of ISO5 / ISO7 / ISO8 manufacturing areas (viable air, viable surface, personnel, and non-viable particulate) as well as inspection for compliance.
• Perform and support Media Fill Validations, Engineering Validations and Cleaning Validations.
• Accurate / legible completion of records and documents for tests performed, and accurate computer data entry / trending / presentation.
• Raw Material / Prefiltration Bioburden / Water sample / Filter integrity testing.
• Media check in and growth promotion.
• Equipment preparation and autoclaving.
• Preparation of microbial ID samples.
• Off testing of incubated environmental monitoring media, testing samples, and Media Fills.
• Use standard laboratory equipment including but not limited to balance, incubator, autoclave, pipettes, and water bath.
• In-process / finished product sample inspection and submission to in-house / third party laboratories.
• Stocking / ordering lab supplies.
• Assist with revision of microbiology / laboratory procedures and documentation.
• Maintenance of close communication and interaction with QC / QA / Production management.
• Utilization of programs for daily workflow (e.g. LIMs).
• Utilization of a Quality Management System (QMS) for training and document review / improvements.
• Potential involvement in procedural / policy improvements within the department.
• Support microbiology laboratory investigations including NONC / EE / Issue reviews / OOS / OOT / No Tests / CAPA.
• Responsible for promoting and maintaining safe and healthy working conditions in his / her assigned work area; instructs and enforces compliance with established safe work practices and procedures; ensures assigned trainees receive appropriate training and information necessary to conduct their activities in a safe and healthy manner.
• Responsible for cleaning and upkeep of the laboratory and testing areas.
• Support gown assessments as needed.
• May perform other duties as qualified / assigned, including but not limited to Sterility , Endotoxin , MET testing, NONC issuance.
• Any additional activities as dictated by updates to Standard Operating Procedure and Policies to ensure compliance with cGMP and regulatory bodies.

Education and Experience :

Knowledge, Skills and Abilities :

Physical Requirements / Working Conditions :