QC Microbiologist I Mon-Fri 3:30 PM - 12AM
LSNE Contract Manufacturing · Bedford, NH · 1 wk ago
AnalystFull-time
About the role
Conducts sampling and testing of production environments, and/or facility clean utilities, as per approved procedures. Performs lab work and other tasks as assigned by management.
Responsibilities
- Perform routine Environmental Monitoring of the classified clean rooms
- Monitor classified clean rooms during manufacturing operations (must gown qualify)
- Sample and test the Water for Injection System, USP Purified Water systems, and Clean Steam systems
- Perform and document plate reads for all environmental and utility testing with minimal supervision
- Write and execute protocols, experiments, and SOPs under limited supervision
- Review work of peers and SOP document changes under limited supervision
- May assist senior staff in preparation of investigations, reports, and execution of complex protocols
- Visual inspection of media fill vials and plates
- Perform general lab maintenance and housekeeping
- Train staff in routine processes
- Other duties as assigned
Special Demands
- Required to stand, walk, sit, use hands to finger, handle or feel objects, tools, or controls, reach with hands and arms, balance, talk, and hear
- Ability to sit or stand for prolonged periods of time
- Must be able to walk and drive between locations
- Physically able to wear laboratory protective gowning and equipment, including gowning, goggles, face shields, and protective gloves
- Must be able to occasionally lift and/or move up to 50 pounds
- Must pass eye exam
- Comfortable with working/handling hazardous materials
- Follow written instructions and perform independent troubleshooting of common issues
- Able to work in a highly complex environment with competing demands and priorities
Work Environment
- Required to stand, walk, sit, use hands to finger, handle or feel objects, tools, or controls, reach with hands and arms, balance, talk, and hear
- Ability to sit or stand for prolonged periods of time
- Physically able to wear laboratory protective gowning and equipment, including gowning, goggles, face shields, and protective gloves
- Must be able to occasionally lift and/or move up to 25 pounds
- Follow written instructions and perform independent troubleshooting of common issues
- Provide expertise for response to complex issues
- Able to work in a highly complex environment with competing demands and priorities
Qualifications
- High school Diploma, GED, or equivalent credential required; AS degree or BS degree in Microbiology or related scientific field preferred
- 3-5 years’ experience in a cGMP environment; equivalent combination of education and experience will be considered
- Detail oriented
- Ability to multi-task
- Ability to gown to work in an ISO-5 environment
- Ability to work varied hours as required by the production schedule