Consumer Safety Officer (Bio-Research Monitoring), GS-0696-13


Vacancy ID: 864652   Announcement Number: HHS-FDA-ORA-MP-13-864652   USAJOBS Control Number: 340435700

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 864652
1. Title of Job

Consumer Safety Officer (Medical Device/Radiological-MQSA), 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 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 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

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. The specialty code for this position is:


001 COMPETITIVE
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:


481730085 Dallas, TX
483280157 Houston, TX

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:

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

1. I am a current employee of the Food and Drug Administration, Office of Regulatory Affairs.

A. Yes
B. No

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

2. 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

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

A. I have a degree that included at least 30 semester hours in one or acombination 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 or 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 describe above.

Please answer yes or no to statement two. 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 announcement closing date.

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.  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.

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

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

7. Serve as the technical authority and principal contact to State and Local government officials, others Federal agencies, private laboratories and industry in the area of bio-research activities.

8. Understand the organizational structures and interrelations of organizations and programs ensuring they relate to the functions in bio-research activities.

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

10. Conduct more complex, technical investigations and inspections of establishments preparing proposed or final endorsements.

11. Advise on new advances in technology related to new programs, laws and regulations, significant court decisions and any new trends or scientific findings in the area of bio-research.

12. Perform investigations involving complaints of injury or death requiring special coordination and high degree of planning, decision making and directing the investigations.

13. Maintain continuous crucial review ensuring that overall program plans are carried out as efficiently and effectively as possible ensuring violations are corrected.

14. Assist in long term investigations, grand juries, or multi-organization investigations with limited oversight directly monitoring  or managing compliance programs for sample collection or inspections programs.

 

15. Review reports of inspections and investigations for violation to determine the sufficiency of the evidence and if investigations are complete or, if additional work is required.

16. Developed operating policies and procedures to establish and provide program strategies.

17. Manage the review of previously approved products determining whether they should continue to be permitted in light of current scientific safety criteria recommending a course of action is needed.

18. Make recommendations to management officials as to whether or not a fir/individual is in compliance with regulatory procedures.

19. Review and evaluate a variety of investigative methods within a programmatic area for use in conducting inspections and investigations.

20. Plans,conducts and directs highly technical, complex inspections and multi-facted inspections and in-depth investigations where there is limited guidance or, new regulations must be used.

21. Conduct inspections of both domestic and international bio-research establishments serving as a member of an international inspection cadre.

22. Advise on new advances in technology related to bio-research, new programs, laws and regulations, significant court decisions and any new findings involving bioresearch.

23. Collaborate with internal offices and governmental agencies coordinating investigations and emergency operations and advising on policy and programmatic directions relating to national public health.

24. Develop and maintain effective communication with regulated industry, consumer groups and the general public in areas involving pre-market testing of human and veterinary pharmaceutical, biologicals, medical devices and bio-pharmaceutical laboratories in the area of bioresearch.

25. Handle hostile or uncooperative industrial offials with tact and firmness to obtain information.

26. Serve as an expert witness in area of expertise in court cases dealing with regulated products.

27. Research and prepare final background papers for approval/signature of upper management.

28. Prepare memoranda, briefings and other background material concerning substantive issues, findings conclusions and proposed solutions to keep management and appropriate staff informed on regulatory changes or issues impacting agency policies.

29. Develop and implement formal training programs for personnel, industry and state/local officials regarding technical and scientific matters, inspectional/investigational issues, policies and laws impacting area of responsibility.

30. Provide written adequate information involving investigations, inspections, lab test results, and breakdowns of imminent or potential hazards to consumer safety.