Industry Compliance Specialist, GS-301-5/7


Vacancy ID: 829889   Announcement Number: HHS-FDA-MP-13-829889   USAJOBS Control Number: 336216600

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 829889
1. Title of Job

Industry Compliance Specialist, GS-301-5/7
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 current Food and Drug Administration (FDA) employees with competitive status only?  Competitive status refers to employees who are serving on a career or career conditional appointment.


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)?


Are you eligible for noncompetitive appointment?
This includes applicants who are eligible for special or noncompetitive appointment authorities such as 30% or more compensable disabled veterans, persons with disabilities and PHS Commissioned Corps Officers.  This also includes applicants who meet the qualifications for this position and who have previously held, or currently hold, a Federal position at the grade of this position.


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 05.


05
07

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 Industry Compliance Specialist

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. From the descriptions below, select the one which best describes your experience and meets the Basic Qualification Requirements for the Industry Compliance Specialist, GS-301-05.

A. I have 3 years of general experience, 1 year of which is equivalent to at least the GS-4 grade level in the Federal service that demonstrates the ability to: Analyze problems to identify significant factors, gather pertinent data, and recognize solutions; plan and organize work; and communicate effectively orally and in writing.

B. I have completed 4 full years of study leading to a bachelor's degree.

C. I have a combination of graduate level education beyond the first 2 years of
progressive graduate study and specialized experience that together meets 100% of the qualification requirements for this position.

D. I do not meet any of the requirements described above.

2. From the descriptions below, select the one which best describes your experience and meets the Basic Qualification Requirements for the Industry Compliance Specialist, GS-301-07.

A. I have at least one year of specialized experience equivalent to the GS-5 level in the Federal service, clerical and administrative work involving compliance program activities; participating in analyzing and modifying existing procedures, entering and extracting data from databases used to record, track, and maintain data and information pertaining to the compliance of FDA laws, rules and regulations; and assisting in the development and implementation of new ways to improve the accuracy, adequacy, and timeliness of administrative functions of an office; and communicating orally and in writing to provide information and respond to inquiries.

B. I have completed 1 full year of graduate level education OR possess superior academic achievement.

C. I have a combination of graduate level education beyond the first 2 years of progressive graduate study and specialized experience that together meets 100% of the qualification requirements for this position.

D. I do not meet any of the requirements described above.

For each task in the following group, choose the statement from the list below that best describes your experience and/or training. 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.

3. Apply knowledge of the Federal Food, Drug and Cosmetic Act to accomplish work.

4. Apply knowledge of the FDA Regulatory Procedures and Compliance programs to accomplish work.

5. Apply directives from other agencies, such as the USDA, Food and Safety and Inspection Service.

6. Participate and/or assist in the investigation of industry violation of compliance to governing rules and regulations.

7. Identify various problems and situations that affect a wide range of compliance activities.

8. Maintain files and manuals related to compliance programs.

9. Utilize an information system to support a variety of compliance programs.

10. Maintain a computerized database for advisory actions, judicial actions, and/or assignments involving compliance programs.

11. Enter information into computer programs and update the Import Tolerance web-pages.

12. Track data information using computer software.

13. Generate reports utilizing computer software/programs.

14. Search databases for information or actions taken on various issues involving industry compliance to FDA regulations, rules and laws.

15. Organize, catalogue, and enter information into computer matrix spreadsheets.

16. Use database management programs to edit and manage a variety of administrative/management data.

17. Prepare special reports, presentations, and summaries.

18. Organize and prepare reports on compliance program activities.

19. Develop reports, memoranda, and other written correspondence to explain study findings and recommendations.

20. Provide written information to others.

21. Participate in meetings and briefings.

22. Discuss issues and/or problems with others to resolve regulatory, compliance action, or data management issues.