Technician, QC Microbiology

BioTissue Holdings Inc

About The Position

Prepare environmental monitoring samples for microbiological testing and other assigned duties as necessary. This role is responsible for the application of approved microbiological techniques and methodologies used in the microbiology department.

Requirements

Basic knowledge of current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs) required
Associate’s degree in microbiology or related field, required.
Dexterity of hands and fingers to operate a computer keyboard, mouse and to handle other communications/computer components
Potential exposure to odors, fumes, airborne particles, hazardous chemicals, and microbiological pathogens
Noise level varies from quiet to loud
Temperature varies from hot to cold
Interactive and fast-paced team-oriented tasks
Occasionally lift and/or move up to 25 pounds
Operate in the cleanroom for up to 5 hours at a time
Color vision and depth perception

Nice To Haves

2 years of experience minimum, preferred.

Responsibilities

Oversees aseptic manufacturing of HCPTs, medical devices and biologics in a cleanroom according to established SOPs
Performs per-process environmental monitoring, routine and non-routine microbiological testing of the cleanroom and its personnel - required.
Performs activities in support of environmental monitoring including viable air, viable surface non-viable air and personnel monitoring
Proficient in microbiological techniques such as Aseptic Technique, Environmental Monitoring, Growth Promotion Testing, Bioburden Testing, Sterility Testing and Endotoxin Testing
Actively participates in the execution of Media Fills, EMPQs and Cleanroom Validations
Supports microbiological test failure investigations (OOS)
Performs all activities in a neat, safe, hygienic, and efficient manner following aseptic technique and sterile gowning
Review and reconcile all environmental monitoring samples at the end of the production to ensure all samples were appropriately taken
Track and trend environmental monitoring data to ensure samples were within limits
Maintains media and reagents as needed for daily microbiological testing
Assists with managing priorities and schedule such that individual goals as well as team goals are achieved
Responsible for the safety of oneself and others working within their area
Responsible for the completion of required training
Other duties as assigned