Responsible for the microbiological testing of pharmaceutical finished products, raw materials, water and environmental samples. Incumbent must comply with Standard Operating Procedures (SOPs), and Human Resources Policies. This position must comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function.
1. Receives and controls microbiological samples submitted for testing in the Microbiology Laboratory.
2. Performs microbiological testing following laboratory methodology, such as Testing Standard, General Method, Specific Method, Pharmacopeia Compendia, and SOPs.
3. Participates in Microbiological Testing validation exercises
4. Reports analytical test results in applicable computerized systems.
5. Reviews laboratory documentation from peers to ensure testing was performed according to laboratory methodology and accuracy.
6. Generates Laboratory Investigations for test results outside of specification and Quality Events.
7. Performs and documents Laboratory Investigations and Quality Events Investigations.
8. Revises laboratory methodology to reflect actual practices.
9. Prepares and sterilizes culture media and laboratory solutions.
10. Performs growth promotion, sterility, and viability tests to culture media.
11. Identifies microorganisms in accordance with laboratory methodology.
12. Verifies calibration of equipment to ensure they are suitable for use.
13. Assures there is adequate inventory of purchased microorganism, culture media, reagents, and laboratory supplies used in the Microbiology Laboratory.
14. Assists the Supervisor in the training of new hired employees.
15. Handles and properly disposes potentially dangerous, regulated hazardous wastes into a designated on-site disposal facility or interim storage container.
16. Files appropriate logs and forms and takes the necessary corrective action in the event of an incident such as a spill, fire or explosion.
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