Your work is performed under general direction from the Laboratory Manager and/or Scientists & Technicians;
Demonstrate competency by complying with established procedures;
Daily duties include:
Temperature Monitoring;
Material / Glassware Preparation;
Depyrogenation cycles;
Environmental Monitoring;
Sample Preparation for Bioburden and Endotoxin Testing;
Paperwork Review;
Data Entry;
Sample Shipment;
Scanning and archiving of laboratory records;
Perform growth promotion testing;
Perform endotoxin testing with the Endosafe method;
Perform leak testing of pipettes;
Investigate and document deviations;
Qualify new LAL reagents for Endosafe method;
Perform Preventive Maintenance on Equipment;
Perform Gram Staining;
Perform Compressed air testing;
Perform water bioburden testing;
Perform endotoxin testing with the Gel Clot method;
Qualify new reagents for Gel Clot testing;
Perform product bioburden testing;
Perform equipment requalification with minimal guidance;
Assist scientists with the validation of new equipment and test methods;
Edit and Revise SOPs as needed;
Other duties as assigned.
- High School Degree/GED;
- Medical device and/or pharmaceutical manufacturing experience or microbiology / chemistry laboratory experience;
- Demonstrated ability to work under minimal direction;
- Possess analytical skills required to troubleshoot basic technical problems;
- Ability to develop solutions to a variety of problems of narrow to moderate scope and complexity;
- Effectively communicate with peers and internal customers to resolve issues related to lab testing;
- Proactively identify potential problems and put in place preventive actions;
- Ability to work independently as well as with teams;
- Excellent written and oral communication skills;
- Skilled with MS office applications;
- Models a positive "can-do" attitude applies skills to achieve team goals;
- Experience/knowledge of cleanrooms and controlled environments (design and operation);
- Experience/knowledge of basic laboratory equipment operation (autoclave, water baths, incubators, freezers, etc.);
- Ability to train manufacturing employees on cleanroom behavior and techniques.