CONSUMER SAFETY OFFICER (DEVICES) GS-696-13


Vacancy ID: 864978   Announcement Number: HHS-FDA-ORA-MP-13-864978   USAJOBS Control Number: 340446300

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 864978
1. Title of Job

CONSUMER SAFETY OFFICER (DEVICES), GS-0696-13
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 a PHS Commissioned Officer (This includes active duty officers, inactive reserve officers, and applicants who have been approved for commissioning in the USPHS Commissioned Corps)?


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

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

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

15. Dates of Active Duty - Military Service

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

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:

Choose 001 – Merit Promotion if you have not held a permanent position at the GS-13 grade level in the Federal service announcement.

Choose 002 - Reassignment or Non-Competitive Promotion if on a permanent basis, you currently hold or have previously held a position at the GS-13 grade level or above; I am a current FDA employee serving under Schedule A appointment; OR I am a current FDA/ORA Commissioned Corps Officer.

 


001 COMPETITIVE PROMOTION
002 REASSIGNMENT/NON-COMPETITIVE

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

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:

Please answer yes or no to statement one.  Your response will determine if you are qualified for the GS-0696-13, Consumer Safety Officer (Devices) position.

1. I have at least one year of specialized experience that has equipped me with the particular knowledge, skills and abilities to successfully perform the duties of the position. This experience is related to the work of the position and equivalent to at least the GS-12 level in the Federal service as described in the vacancy announcement.

A. Yes
B. No

2. From the description below, select the one which best describes your education and/or experience and meets the basic qualification requirements for GS-0696, Consumer Safety Officer.

A. I have a degree that included at least 30 semester hours in one or a combination of the following: biological sciences, chemistry, pharmacy, physical sciences, food technology, nutrition, medical science, engineering, epidemiology, veterinary medical science, or related scientific fields that provided knowledge directly related to consumer safety officer work. The 30 semester hours can include up to 8 semester hours in statistics, or course work that included the principles, theory, or practical application of computers or computer programming.
B. I have a combination of education and experience consisting of at least 30 semester hours in the fields of study as described in "A" above, plus appropriate experience or additional education.
C. I do not possess the education and/or experience described above.

Please answer yes or no to the statement below.  Your response will determine if you meet the time-in-grade requirement for this position.

3.

I have 52 weeks at the GS-12 grade level or above in the Federal Service within 30 days of the closing date of the announcement.

A. Yes
B. No

Your response to the statement below will determine if you meet the area of consideration.

4. I am a current employee of the Food and Drug Administration, Office of Regulatory Affairs OR I am a current FDA/ORA Commissioned Officer OR I am a current FDA/ORA employee serving under the SCH-A appointment.

A. Yes
B. No

Your response to the statement below will determine if you are eligible for non-competitive referral.

5. Please select the appropriate response from the list below.

A. I am currently serving in a permanent position at the GS-13 grade level or above in the Federal Service.
B. I have previously served in a permanent position at the GS-13 grade level or above in the Federal Service.
C. I am a current FDA/ORA Commissioned Officer (attach personnel order) OR I am a current FDA/ORA employee serving under Schedule-A appointment (attached certification and SF-50)
D. I do not meet any of the conditions as described in A, B, or C.

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.
Note: Submission of this electronic questionnaire is certification that all responses are true to the best of your knowledge. Materially false, fictitious, or fraudulent statements or representations are subject to disciplinary action.

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. Serve as an expert in inspectional and investigative techniques and technical knowledge in GMP inspections of medical device manufacturers.

7. Conduct inspectional/investigative analysis in the area of medical devices and develop evidence when situations are encountered that may result in regulatory action.  

8. Conduct research to develop improved inspectional techniques requisite for coping with advances in manufacturing technology and  practices. 

9. Serve as an expert; research and resolve recurring problems encountered by other Field Offices or other Regions.

10. Work with a complex category of products or a functional specialty pertaining to medicine, science, and/or technologies involving legal, regulatory, and diplomatic concepts necessary to enforce the laws.

11. In-depth knowledge of a category of products or a functional specialty which is distinctly more difficult to work with because of the medicine, science, and/or technologies involved and because the legal, regulatory, and diplomatic concepts necessary to enforce the law are correspondingly more complex and/or unprecedented.

12. Perform complex assignments in the international arena which require extensive scientific knowledge of the particular industry practices accumulated by experience in investigations and inspections.

13. Consult and participate in the formulation and developing of inspectional and investigational procedures and techniques.

14. Ability to effectively negotiate and resolve issues in sensitive situations arising in highly complicated assignments.

15. Communicate agency requirements, policies and procedures.

16. Interact, routinely and coordinate with foreign governments.

17. Provide testimonial presentations used as instruments for negotiations; conduct negotiations with industry representatives and other government agencies.

18. Prepare and propose endorsements with an inspection conclusion and district decision.

19. Prepare written reports, findings, and recommendations; develop analyses that are used for disposition of cases and formal training programs. 

20. Review drafts and proposals pertaining to the promulgating of regulations making analyses if such are feasible or desirable.