Technician, QC Microbiology

About the Role

Prepare environmental monitoring samples for microbiological testing and perform other assigned duties in the microbiology department using approved techniques and methodologies.

Responsibilities

• Promote aseptic manufacturing of HCPTs, medical devices, and biologics in a cleanroom according to established SOPs.
• Perform per-process environmental monitoring, routine and non-routine microbiological testing of the cleanroom and its personnel.
• Support environmental monitoring activities including viable air, viable surface, non-viable air, and personnel monitoring.
• Read, interpret, and document incubation and inspection of environmental monitoring samples accurately and timely.
• Apply microbiological techniques such as Aseptic Technique, Environmental Monitoring, Growth Promotion Testing, Bioburden Testing, Sterility Testing, and Endotoxin Testing.
• Participate in the execution of Media Fills, EMPQs, and Cleanroom Validations.
• Perform all activities neatly, safely, hygienically, and efficiently following aseptic technique and sterile gowning.
• Review and reconcile all environmental monitoring samples at the end of production to ensure completeness.
• Track and trend environmental monitoring data to ensure samples remain within limits.
• Maintain media and reagents as needed for daily microbiological testing.
• Manage priorities and schedule to achieve individual and team goals.
• Ensure personal safety and the safety of others in the work area.
• Complete required training for gowning qualifications, aseptic techniques, and environmental monitoring.

Requirements

• Proficiency in microbiology, including aseptic techniques, sterility testing, bioburden testing, and environmental testing.
• Dexterity to operate computer keyboards, mice, and handle other communications/computer components.
• Ability to organize effectively and adapt quickly to changes in priorities.
• Basic knowledge of current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs).
• Associate’s degree in microbiology or related field (required).
• Minimum of 2 years of experience (preferred).

Skills

• Strong written and verbal communication skills in English.
• Computer proficiency in Microsoft Word and Excel.
• Color vision and depth perception.

Working Conditions

• Potential exposure to odors, fumes, airborne particles, hazardous chemicals, and microbiological pathogens.
• Temperature variations from hot to cold.
• Interactive, fast-paced, and team-oriented tasks.
• Occasional lifting and/or moving up to 25 pounds.
• Ability to operate in the cleanroom for up to 5 hours at a time.

Physical Requirements

Sedentary work that generally requires sitting and/or standing.