1. From the options below, please select the response that best describes the education or experience you possess that fulfills the basic requirements of this position.A. I possess a degree in microbiology; or in biology, chemistry, or basic medical science that included at least 20 semester hours in microbiology and other subjects related to the study of microorganisms, and 20 semester hours in the physical and mathematical sciences combining course work in organic chemistry or biochemistry, physics, and college algebra, or their equivalent.
2. I possess one or more years of specialized experience equivalent the GS-12 level of the Federal service performing the following duties: reviewing and evaluating microbiological protocols, procedures and data submitted with Abbreviated New Drug Applications (ANDA's); participating in the continuing review of technical and scientific literature within the field of microbiology; evaluating legal actions involving scientific issues to determine if there is enough evidence to sustain the position of the organization; evaluating and consulting on the labeling of drug products with an emphasis on the description and use of instructions; reviewing and advising on methodology and data submitted for product safety and efficacy.A. Yes
For each task in the following group, choose the statement from the list below that best describes your experience and/or training. Darken the oval corresponding to that statement in Section 25 of the Qualifications and Availability Form C. Please select only one letter for each item.A- I have not had education, training or experience in performing this task.
3. Provide support relating to staff elements involved in the review of microbiological aspects of Abbreviated New Drug Applications (ANDA) submissions.
4. Review and evaluate microbiological protocols, procedures and data submitted with ANDA's.
5. Review microbiological validation of sterilization, aseptic processing and sterility test methods submitted with ANDA's.
6. Participate in continuing review of technical and scientific literature.
7. Attend meetings and conferences in which drugs are discussed and the latest research results are presented.
8. Attend courses and seminars to remain current on developments in the field.
9. Advise supervisor of problems or issues arising in the discipline of microbiology.
10. Participate in the establishment of technical programs and objectives.
11. Evaluate legal actions that involve scientific issues to determine if there is enough evidence to sustain the position of the organization.
12. Review protocols, records, and observations, reporting findings complete with statistical analysis.
13. Evaluate and consult on the labeling of products with an emphasis on the description and use of instructions.
14. Communicate with staff and outside parties in writing to maintain an awareness of program progress.
15. Review and advise on aspects of quality control.
16. Consult and advise on methodology and data submitted for product safety and efficacy.
17. Communicate with sponsor or applicant for clarification of procedures and data related to documents submitted.