CHEMIST, GS-1320-12/13


Vacancy ID: 840194   Announcement Number: HHS-FDA-CDER-MP-13-840194   USAJOBS Control Number: 337483800

Occupational/Assessment Questions:

1. This position requires that applicants demonstrate that they have taken course work in mathematics through differential and integral calculus. Have you taken this course AND is it demonstrated in your transcript(s) that you submitted?

A. Yes (transcript demonstrating this must be submitted before the closing date of the job announcement)
B. No

If you selected response A above, where on your transcript(s) can the class Differential and Integral Calculus be found? (Please provide in the space below the course title, title number (if applicable) , dates taken, and school). Please note that the agency may request, at a later time during the application process, that you provide the course description and/or verification letter from the school demonstrating that this class is equivalent to the required course for the 1320 Chemist series.

2. In addition to the differential and integral calculus course noted above. This position requires that applicants demonstrate that they have taken course work to include 30 semester hours in chemistry, and at least 6 semester hours of physics. Have you taken these courses AND is it demonstrated in your transcript(s) that you submitted?

A. Yes (transcript demonstrating this must be submitted before the closing date of the job announcement)
B. No

3. From the descriptions below, select the response which demonstrates your experience and/or education as required in meeting the Basic Qualification Requirements for the Chemist, GS-1320.

A. I have a bachelor's degree in physical sciences, life sciences, or engineering.(Transcript must be submitted)
B. I have a combination of education and experience plus appropriate experience or additional education. (Transcript must be submitted.)
C. I do not have the education as noted in response A above OR I do not have a combination of experience and education as noted in response B above.

4. 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.

A. I possess one year of specialized experience equivalent to at least the GS-11 level in the Federal service. For this position, specialized experience is experience reviewing and analyzing the chemical processes and/or formulation involved in the manufacturing of human drugs.
B. I do not possess the specialized experience requirements as described above.

5. 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.

A. I possess one year of specialized experience equivalent to at least the GS-12 level in the Federal service. For this position, specialized experience is experience leading the review and analysis of chemical processes and/or formulation involved in the manufacturing of human drugs.
B. I do not possess the specialized experience requirements as described above.

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.
B- I have had education or training in performing the task, but have not yet performed it on the job.
C- I have performed this task on the job. My work on this task was monitored closely by a supervisor or senior employee to ensure compliance with proper procedures.
D- I have performed this task as a regular part of a job. I have performed it independently and normally without review by a supervisor or senior employee.
E- I am considered an expert in performing this task. I have supervised performance of this task or am normally the person who is consulted by other workers to assist them in doing this task because of my expertise.

6. 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.

7. Evaluate the adequacy of generic drug industry methods and acceptance criteria of quality standards for drug substance and drug product.

8. 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.

9. Evaluate the correctness of formulas and the adequacy of manufacturing controls both in process and on the finished dosage form.

10. Evaluate the adequacy of packaging and storage procedures and the suitability of containers used in packaging the drug product for marketing.

11. Evaluate and incorporate the latest developments and changes into human drug quality assessment and safety guidelines and regulations.

12. Develop risk based approaches to the analysis and review of physical and chemical properties regarding the quality and stability of human drugs.

13. Prepare written evaluations showing results of scientific review.

14. Ensure appropriate reporting of the chemical components, manufacturing, processing, packaging, control operations, stability, and the technical labeling.

15. 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.

16. Prepare validations of analyses, submitted as part of the applications or through literature search.