Chemist, GS-1320-13


Vacancy ID: 869979   Announcement Number: HHS-FDA-CVM-DE-13-869979   USAJOBS Control Number: 341174600

Social Security Number

Enter your Social Security Number in the space indicated. Your Social Security Number is requested under the authority of Executive Order 9397 to uniquely identify your records from those of other applicants who may have the same name.  As allowed by law or Presidential directive, your Social Security Number is used to seek information about you from employers, schools, banks and others who may know you. Providing your Social Security Number is voluntary, however we can not process your application without it.


Vacancy Identification Number

Enter 869979
1. Title of Job

Chemist, GS-1320-13
2. Biographic Data

3. E-Mail Address

4. Work Information

If you are applying by the OPM Form 1203-FX, leave this section blank.

5. Employment Availability

Are you eligible for the Federal Employment Program for Persons with Disabilities? (For information on Schedule A appointments, see the OPM website.)


6. Citizenship

Are you a citizen of the United States?
7. Background Information

If you are applying by the OPM Form 1203-FX, leave this section blank.

8. Other Information

If you are applying by the OPM Form 1203-FX, leave this section blank.

9. Languages

If you are applying by the OPM Form 1203-FX, leave this section blank.

10. Lowest Grade

Enter the lowest grade level that you will accept for this position. The lowest grade for this position is 13.


13

11. Miscellaneous Information

If you are a male at least 18 years of age, born after December 31, 1959, have you registered with the Selective Service System?


01 Yes
02 No
03 Not Applicable

12. Special Knowledge

If you are applying by the OPM Form 1203-FX, leave this section blank.

13. Test Location

If you are applying by the OPM Form 1203-FX, leave this section blank.

14. Veteran Preference Claim

15. Dates of Active Duty - Military Service

16. Availability Date

17. Service Computation Date

If you are applying by the OPM Form 1203-FX, leave this section blank.

18. Other Date Information

If you are applying by the OPM Form 1203-FX, leave this section blank.

19. Job Preference

If you are applying by the OPM Form 1203-FX, leave this section blank.

20. Occupational Specialties

Select/enter at least one occupational specialty. The specialty code for this position is:


001 Chemist

21. Geographic Availability

Select/enter at least one geographic location in which you are interested and will accept employment. The location code for this position is:


241360031 Rockville, MD

22. Transition Assistance Plan

If you are applying by the OPM Form 1203-FX, leave this section blank.

23. Job Related Experience

If you are applying by the OPM Form 1203-FX, leave this section blank.

24. Personal Background Information

If you are applying by the OPM Form 1203-FX, leave this section blank.

25. Occupational/Assessment Questions:

1. Are you a current career or career-conditional FDA/Center Veterinary Medicine federal employee with competitive status?

A. Yes
B. No

2. From the description below, select the one which best describes your education and meets the Basic Qualification Requirements for Chemist, GS-1320.

A. I have a 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.

B. I have a combination of education and experience -- course work equivalent to a major as shown in A above, including at least 30 semester hours in chemistry, supplemented by mathematics through differential and integral calculus, and at least 6 semester hours of physics, plus appropriate experience or additional education.

C. I do not possess the education and/or experience described above.

3. From the descriptions below, select the one which best describes your experience and meets the Additional Qualification Requirements for Chemist, GS-1320-13.

A. I have one year of specialized experience, equivalent to the GS-12 grade level in the Federal service, experience includes preparing and/or evaluating the chemistry, manufacturing and control information in a new animal drug application to determine whether it will possess and maintain appropriate chemical quality attributes throughout its marketed shelf-life; and serving as a resource to other scientists and stakeholders in multiple areas related to chemistry (e.g., analytical, organic, industrial research, protein chemistry, virology, flow cytometry), and technology (manufacturing, quality control, sterile process validation).

B. I do not possess the specialized experience 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.

4. Evaluate the chemistry, manufacturing, and control information in an application to determine whether it will possess and maintain appropriate chemical quality attributes throughout its marketed shelf-life.

5. Evaluate applications to determine whether there are unique scientific and regulatory issues associated with the type of drug product or manufacturing processes under consideration.

6. Determine whether or not animal drug products have adequate controls to prevent microbiological contamination.

7. Evaluate pharmaceutical manufacturing and control methods and procedures during scientific reviews.

8. Evaluate all aspects of product stability during scientific reviews.

9. Conduct scientific reviews of New Animal Drug Applications, Master Files, Investigational New Animal Drug Applications, and other post approval documents for technical information supporting the chemistry manufacture and control of an animal drug product.

10. Prepare comprehensive written plain language evaluations and conclusions for each drug application regarding the sterile manufacturing process and/or scientific validity.

11. Participate in meetings with sponsors and peers to discuss issues pertaining to chemistry, manufacturing, and controls.

12. Prepare reviews as to whether or not an application is sufficient to assess conformity with Current Good Manufacturing Practice requirements.

13. Your responses in this Assessment Questionnaire are subject to evaluation and verification. Later steps in the selection process are specifically designed to verify your responses. Deliberate attempts to falsify information will be grounds for disqualifying you or for dismissing you from employment following acceptance. Please take this opportunity to review your responses to ensure their accuracy.

If you fail to answer this question, you will be disqualified from consideration for this position.

I certify that, to the best of my knowledge and belief, all of the information included in this questionnaire is true, correct, and provided in good faith. I understand that if I make an intentional false statement, or commit deception or fraud in this application and its supporting materials, or in any document or interview associated with the examination process, I may be fined or imprisoned (18 U.S.C. 1001); my eligibilities may be cancelled, I may be denied an appointment, or I may be removed and debarred from Federal service (5 C.F.R. part 731). I understand that any information I give may be investigated. I understand that responding "No" to this item will result in my not being considered for this position.

A. Yes, I certify that the information provided in this questionnaire is true, correct and provided in good faith, and I understand the information provided above.
B. No, I do not certify/understand the information provided above.