Microbiology Technician I at this facility will perform quantitative and qualitative analysis of our compounded admixed product for distribution to customers nationwide. The Microbiologist I will abide by all documentation procedures and maintain a level of professionalism throughout each working day.
The scientist must be familiar with and knowledgeable of cGMP/GLP and FDA 21 CFR Part 11 procedures. All applicants for this position must embody and demonstrate the PharMEDium Core Values: Patient Safety, Flawless Quality, Operational Excellence, Employee Well Being, Service Excellence, and Respectful and Collaborative Environment.
This job position is compliance critical and responsibilities include ensuring continual and proper compliance with all division, corporate, and government regulatory requirements. It is the associate's responsibility to observe all safety rules. Any condition thought to be hazardous or unsafe should be reported to your supervisor immediately.
1.Adheres to all cGMP, safety regulations, and understands SOP's with minimal supervision.
2.Perform testing using aseptic techniques in a laminar airflow clean bench
3.Organize the receiving, storing and logging in of samples from the clean room or inventory
4.Support in all regulatory inspections: FDA, DEA, Board of Pharmacy, and internal audits
5.Per procedures maintain all documents for laboratory analysis
6.Review and approve data generated by other scientists and sterility technicians
7.Maintenance of laboratory notebooks
8.Maintain the daily cleanliness of the laboratory
9.Assist with updating Supply Inventory for Laboratory
10. Follow Standard Operating Procedures
11. Maintenance of Laboratory Documents
12. Understand OOS/investigative reports
13. Develop quality reports
14. Performs related duties as assigned
1.Working in an FDA environment
2.BS Degree in Applicable science (Biology, Biochemistry, Microbiology or other related Cellular/Molecular Biology field) with 0-2 years of aseptic laboratory experience (college laboratory experience accepted).
3.Knowledge of fluorescent based assays and identification of bacteria and molds
4.Experience in FDA regulated industry.
5.Strong knowledge of microscopy and troubleshooting for all sterility instrumentation
6.Effective organization and planning skills
7.Efficient in troubleshooting laboratory equipment
8.Excellent technical and verbal skills
9.Must have the ability to multi-task
10. Have problem solving skill set
11. Computer knowledge of data collection systems and/or spreadsheet software, e.g. Microsoft Word, Excel, LIMS and PowerPoint
12. Understanding and Experience utilizing the USP Compendia methods
13. Knowledge of sterility analysis, GLP documentation of experiments, and quantitative analysis.
14. Ability to travel up to 5%
15. Knowledge of Environmental Monitoring is a plus
16. Must be able to work some weekends or as required by management
17. Knowledge of laboratory safety
Amerisourcebergen Corporation - Corporate