1. From the descriptions below, select the one which best describes your experience or education which meets the Basic Qualification Requirements for the Chemist, GS-1320.A. I have a bachelor's degree in physical sciences, life sciences, or engineering that included 30 semester hours in chemistry, supplemented by course work in mathematics through differential and integral calculus, and at least 6 semester hours of physics. (You must submit transcripts at time of application submission that demonstrates the required coursework noted above.)
2. In addition to meeting the basic qualification requirements, you must meet the specialized experience requirements to qualify at the GS-12 level. From the descriptions below, select one response that best describes how your background meets the specialized experience requirements for a Chemist, GS-1320-12 position.
3. In addition to meeting the basic qualification requirements, you must meet the specialized experience requirements to qualify at the GS-13 level. From the descriptions below, select one response that best describes how your background meets the specialized experience requirements for a Chemist, GS-1320-13 position.
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.
4. Evaluate the adequacy of drug industry methods used in, and the controls used for the manufacture of drug substances to establish and preserve their identity, quality, purity, and stability.
5. Evaluate the adequacy of generic drug industry methods and acceptance criteria of quality standards for drug substance and drug product.
6. Evaluate the adequacy of drug industry methods used in, and the controls used for the manufacture of drug products to establish and preserve their identity, strength, quality, purity, and stability.
7. Evaluate the correctness of formulas and the adequacy of manufacturing controls both in process and on the finished dosage form.
8. Evaluate the adequacy of packaging and storage procedures and the suitability of containers used in packaging the drug product for marketing.
9. Evaluate and incorporate the latest developments and changes into human drug quality assessment and safety guidelines and regulations.
10. Develop risk based approaches to the analysis and review of physical and chemical properties regarding the quality and stability of human drugs.
11. Prepare written evaluations showing results of scientific review.
12. Ensure appropriate reporting of the chemical components, manufacturing, processing, packaging, control operations, stability, and the technical labeling.
13. Prepare recommendations for manufacturing facility inspections to obtain further information on the process controls used in the manufacturing of the active ingredient and finished dosage forms described in the application.
14. Prepare validations of analyses, submitted as part of the applications or through literature search.