CONSUMER SAFETY OFFICER (DRUGS), GS-696-13


Vacancy ID: 878593   Announcement Number: HHS-FDA-ORA-MP-13-878593   USAJOBS Control Number: 342227500

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 878593
1. Title of Job

CONSUMER SAFETY OFFICER (DRUGS), 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:


130280121 Atlanta, GA
373750183 Raleigh, NC

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 (Drugs) 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.

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

3. I am a current career/career conditional employee of the Food and Drug Administration OR I am a current FDA Commissioned Corps Officer.

A. Yes
B. No

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

4.

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 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 Commissioned Corps Officer (attach personnel order).
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. Responsible for interpretation and application of the Food, Drug and Cosmetics Act, Current Good Manufacturing Practices (CGMP), and related industry practices and regulations ensuring accuracy and completeness of objectives.

7. Responsible for understanding the organizational structures and interrelationships of compliance organizations and programs, ensuring they relate to area of responsibility.

8. Formulate recommendations based on background and understanding of policies, regulations, procedures and information.

9. Ensures documentation and practices of firms are in compliance with laws, rules and regulations in protecting public health.

 

10. Remain current in compliance areas of pharmaceuticals (human or veterinary) in order to utilize and apply the latest technologies and skills when evaluating documents.

11. Make recommendations to management officials regarding whether or not a firm/individual involved in drugs (human/veterinary) is in compliance with Good Manufacturing Practices (GMP).

 

12. Maintain crucial review of overall program to ensure applicable laws, guidance and policies are followed and implemented in accomplishing assigned tasks.

13. Develop and interpret established operating policies and procedures in order to formulate and recommend plans, leadership, guidance and program strategies.

 

14. Review reports of inspections and investigations for violations to determine the sufficiency of evidence obtained.

15. Manage the review of previously approved products to determine whether they should continue to be permitted in light of current scientific safety criteria, recommending a course of action when needed.

16. Act upon full range of violations within the area of expertise, including emergency situations, to ensure violation/s is/are corrected.

17. Review and evaluate test methods and new automated methods of processing and analysis.

 

 

18. Conduct inspections and investigations of facilities where only limited guidance documents are available or new regulations must be used in evaluating the industry.

19. Conduct more complex, technical investigations and inspections of pharmaceutical establishments, preparing proposed final endorsements.

20. Perform investigations involving complaints or injury or death requiring special coordination and a high degree of insight, planning and deciding and directing the investigation.

21. Analyze results, decide when an investigation is incomplete or what additional work may be required, providing timely and accurate feedback to management.

22. Plan, conduct and direct highly technical, complex and multi-faceted inspections and in-depth investigations related to the production, control, testing and processing of human or veterinary pharmaceutical products.

23. Assist in long term investigations and grand juries, with possible designation as the lead Agency representative of multi-agency/multi-organization investigations with limited oversight.

24. Assist in or directly monitor compliance programs used for sample collections and/or inspection programs.

25. Advise on new advances in technology related to drug products, new programs, laws and regulations, significant court decisions and new trends or scientific findings involving drug products.

26. Make recommendations to management officials when a manufacturer of pharmaceuticals  (human or veterinary) is not in compliance with good manufacturing practices.

27. Skilled in interviewing and criminal investigations techniques, making recommendations to higher management officials whether or not an establishment is in violation of the CGMP.

28. Meet with industry representatives, exchanging information and providing advice and guidance regarding deficiencies.

29. Handle hostile or uncooperative industrial officials with tact and firmness to obtain needed information.

30. Provide extensive advisory, liaison and consultative services for drug programs to regulated industries, State agencies and other Federal agencies and management.

31. Serve on task forces and study groups considering problems or directions in the area of drug manufacturing.

32. Serve as expert witness in court cases dealing with regulated products in the area of human or veterinary pharmaceutical products.

33. Prepare reports, briefings and other background material concerning substantive issues, findings, conclusions and proposed solutions, keeping appropriate staff involved at key decision points.

34. Evaluate and make recommendations on necessary regulatory action, preparing reply stating Agency concerns.

35. Prepare proposed or final Establishment Inspection Report (EIR) endorsements with reports developed and accepted with little or no review of oversight.

36. Develop and implement formal training programs for personnel, industry and state/local officials, providing technical expertise as needed.