CONSUMER SAFETY OFFICER (DRUG SPECIALIST), GS-0696-13


Vacancy ID: 817063   Announcement Number: HHS-FDA-ORA-MP-13-817063   USAJOBS Control Number: 334726000

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 817063
1. Title of Job

CONSUMER SAFETY OFFICER (DRUG SPECIALIST), 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 an ICTAP Eligible?

For information on how to apply as an ICTAP eligible see http://opm.gov/rif/employee_guides/career_transition.asp#ictap.  To be well-qualified and exercise selection priority for this vacancy, displaced Federal employees must be rated at 85.0 or above on the rating criteria for this position.


Are you eligible for Indian preference as defined by the Department of the Interior (DOI) and as evidenced by appropriate Bureau of Indian Affairs (BIA) authorized certification?


Are you eligible for preference based on being a Public Law 94-437 Indian Health Service Scholarship recipient? For more information, please click here.    


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


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 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 MERIT PROMOTION
002 REASSIGNMENT/NON-COMPETITIVE PROMOTION

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:


251275017 Stoneham, MA

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-13 Consumer Safety Officer (Drug Specialist) 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 GS-12 level in the Federal Service as described in the vacancy announcement.

A. Yes
B. No

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

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

A. Yes
B. No

3. From the descriptions 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 - with courses consisting of at least 30 semester hours in the fields of study previously described, plus appropriate experience or additional education.
C. I do not possess the education and/or experience described above.

4. From the descriptions below, select the one which best describes your highest level of training/certification received or completed.

A. Completion of Level III Certification and routinely conducted independent complex drug/pharmaceutical inspections.
B. Completion of Level III Certification
C. Completion of Level II Certification
D. Completion of Level I Certification and on-the-job experience.
E. Completion of basic drug training and experience conducting moderately complex drug/pharmaceutical facilities.

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 currently in or have held a permanent trainee position at the GS-13 grade level or above in the Federal Service.
D. I have not held any of the grade levels as described in A, B, or C.

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

6. I am a current employee of the Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), New England District or a FDA, ORA Commissioned Officer.

A. Yes
B. No

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 and provide examples/details addressing each task in your resume. 
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.

7. Interpret and apply the Food, Drug, and Cosmetics Act, Current Good Manufacturing Practices (CGMP), and related industry practices and regulations ensuring accuracy and completeness of objectives.

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

9. Understand the organizational structures and interrelationships of compliance organizations and programs ensuring they relate to area of responsibility.

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

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

12. Make recommendations to management officials as to whether or not a firm/individual involved in drug-human/veterinary is in compliance with GMP regulations.

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

14. Prepare comprehensive reports documenting violations that support subsequent compliance/enforcement action.

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

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

17. Act upon full range of violations within the area of expertise including emergency situations ensuring violation is corrected.

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

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

20. Conduct more complex, technical investigations and inspections of drug/pharmaceutical establishments preparing proposed final endorsement.

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

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

23. 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 drug/pharmaceutical products.

24. Assist in long term investigations and grand juries, and may be designated as the lead Agency representative of multi-agency/multi-organization investigations with limited oversight.

25. Assist in or directly monitors compliance programs used for sample collection and/or inspection programs.

26. 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.

27. Make recommendation to management officials when a manufacturer of pharmaceutical (human or veterinary) is not in compliance with good manufacturing practices.

28. Interview, investigate, and make recommendations to higher management officials as to whether or not an establishment is in violation of the CGMP.

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

30. Handle hostile and uncooperative industry official with tact and firmness to obtain information needed.

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

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

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

34. Provide training and guidance as an expert to other staff members.

35. Prepare reports, briefings, and other background material concerning substantive issues, findings, conclusions, and proposed solutions.

36. Evaluate the situation and make recommendation on necessary regulatory action in response to Agency concerns.

37. Prepare proposed or final EIR endorsements with reports developed and accepted with little or no review or oversight.

38. Develop and implement formal training programs for personnel, industry, and state/local officials.