Technician, QC Microbiology

Position Summary

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.

Essential Duties & Responsibilities

• Promotes 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

• Preform timely reading, accurate interpretation and documentation of incubation and inspection of EM samples.

• 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

• 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 for gowning qualifications, aseptic techniques and environmental monitoring.

Skills & Abilities

• Proficiency in microbiology including aseptic techniques, sterility testing, bioburden testing and environmental testing
• Dexterity of hands and fingers to operate a computer keyboard, mouse and to handle other communications/computer components
• Ability to organize effectively and to adapt quickly to changes in priorities.
• Potential exposure to odors, fumes, airborne particles, hazardous chemicals, and microbiological pathogens
• 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
• Strong written and verbal communication skills in English.
• Computer Proficiency – Word and Excel

Position Expertise/Qualifications

• Basic knowledge of current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs) required
• Associate’s degree in microbiology or related field, required.
• 2 years of experience minimum, preferred.

Physical Requirements

• Sedentary work that generally requires sitting and/or standing