This Position Is No Longer Available
  1. Overview
  2. Duties
  3. Qualifications & Evaluations
  4. Benefits & Other Info
  5. How to Apply

Job Title:Consumer Safety Officer (OVERSEAS), GS-696-11/12/13/14

Department:Department Of Health And Human Services

Agency:Food and Drug Administration

Job Announcement Number:HHS-FDA-OC-DE-13-792594

This position is closed and no longer accepting online applications through USAJOBS.

The contents of the announcement can still be viewed.

SALARY RANGE:

$50,287.00 to $110,104.00 / Per Year

OPEN PERIOD:

Tuesday, February 19, 2013 to Monday, August 19, 2013

SERIES & GRADE:

GS-0696-11/14

POSITION INFORMATION:

Full Time - Term NTE 2 Years

DUTY LOCATIONS:

Many vacancies in the following location(s):
Guangzhou ChinaView Map
New Delhi IndiaView Map
Beijing ChinaView Map
Mumbai IndiaView Map
Shanghai ChinaView Map
More Locations  (2)

WHO MAY APPLY:

United States Citizens

JOB SUMMARY:

Become a part of the Department that touches the lives of every American!  At the Department of Health and Human Services (HHS) you can give back to your community, state, and country by making a difference in the lives of Americans everywhere.  It is the principal agency for protecting the health of citizens.  Join HHS and help to make our world healthier, safer, and better for all Americans.

This position is located in the Department of Health and Human Services (DHHS), Food and Drug Administration (FDA), Office of Global Regulatory Operations and Policy (OGROP), in the Office of International Programs (OIP), FDA Foreign posts. This position has 7 different locations: New Delhi, India; Mumbai, India; Mexico City, Mexico; Shanghai, China; Beijing, China, Hyderabad, India and Guangzhou, China.
Who May Apply:  Open to all United States Citizens.
This announcement may be used to fill multiple positions in multiple locations.

Overseas Assignments: Overseas assignments are for two years and a rotational agreement must be signed. The assignment may be extended up to a total of four years based on the needs of the agency. Subsequent employment for other FDA positions must be through the appropriate competitive process or special employment program hiring authorities.

Immunizations are required and will be administered by the FDA before relocating overseas, when applicable.

Before relocating overseas, the selectee may remain stateside until all clearances have been approved.

Employment is contingent on passing required medical and security clearances.

Security clearances are required for the selectee only and medical clearances are required for selectee and all family members before being posted overseas.   Inability of selectee to secure the clearances for overseas duty within six (6) months will result in termination of appointment to the position.

Citizens or permanent residents of the host country are not eligible to be considered.

Additional information on living and traveling abroad may be found at

http://aoprals.state.gov/content.asp?content%20id=184&menu%20id=78.

Special Notes:

Although this vacancy announcement is advertised for multiple duty locations, and grade levels, it is not intended to convey any implication nor expectation that positions will be filled at all grade levels or locations. Based upon the position responsibilities and/or Department of Health and Human Services hiring office, the full performance level of the positions may vary.

This announcement is being used to create an inventory of applicants for Consumer Safety Officer positions and will be used to fill immediate and future needs. Applicants are encouraged to apply early in order to maximize their employment opportunities. Your application will remain in the inventory of tentatively qualified applicants. Applicants that are among the best qualified will be referred to the selecting official for consideration as requests to fill vacancies are processed by the Human Resources Center. Thereafter, additional referral lists will be generated throughout the open period as vacancies occur. If further evaluation or interviews are required, you will be contacted.

This position is eligible for special pay allowances (e.g. post differential, cost of living, housing, relocation expenses, etc.). Reference the Department of State, Office of Allowances at http://aoprais.state.gov.
Immunizations are required and will be administered by the FDA before relocating overseas, when applicable.

Before relocating overseas, the selectee may remain stateside until all clearances have been approved.

Employment is contingent on passing required medical and security clearances.

Security clearances are required for the selectee only and medical clearances are required for selectee and all family members before being posted overseas. Inability of selectee to secure the clearances for overseas duty within six (6) months will result in termination of appointment to the position.

Citizens or permanent residents of the host country are not eligible to be considered.

Current permanent status FDA employees will be processed using the appropriate temporary promotion or other temporary assignment authority for permanent employees FDA. The selectee will have statutory return rights to their permanent FDA position title, series, and grade once the overseas assignment is completed.

Other current permanent status Federal employees will be hired on a term appointment. There are not statutory return rights. Subsequent employment for FDA positions must be through the appropriate competitive process or special employment program hiring authorities.

All other selectees (e.g., reinstatement eligibles, veterans, persons with disabilities, etc.) will be hired through a term-appointment. Subsequent employment of FDA positions must be through the appropriate competitive process or special employment program hiring authorities.

Additional information on living and traveling abroad may be found at http://aoprais.state.gov/default.asp

Initial cutoff will be 2 weeks from the announcement's opening date.

KEY REQUIREMENTS

  • U.S. Citizenship is required.
  • Background investigation required.
  • Security and Medical clearances required.
  • Travel is required.
  • Salary information listed does not include locality pay.

DUTIES:

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This is primarily an investigator position, and for inspection work, the incumbent will receive inspectional/investigational assignments and technical supervision directly from the Office of Regulatory Affairs (ORA) Headquarters following established procedures (with the exception of those selected for positions in Shanghai, who will receive assignments from a Supervisory Consumer Safety Officer).

If selected for this position you will:

- Serve as an Assistant Country/Regional Director in foreign investigation/inspection assignments (primarily foods, feeds, medical devices, clinical trials/research, drugs or biologics) in one of FDA Foreign Post.

- Serve as the focal point within FDA to whom headquarters and field service may turn for authoritative guidance and consultation regarding inspectional and investigational methods and procedures necessary to accomplish compliance objectives in their major functional area and country/region of assignment.

- Make recommendations that may affect the status or decision of the Agency as to the status of domestic or foreign products or to permit the entry of the inspected product.

- Provide a focal point within FDA to whom foreign manufacturers may turn for technical expertise regarding inspectional activities and how to comply with GMPs or other regulatory requirements and investigation methods and procedures necessary to accomplish compliance objectives.

- Develop and implement formal training programs regarding technical and scientific matters, inspectional/investigational issues, policies, and laws for industry representatives, foreign governments , and local officials.

- Conduct on-the-job and other training for investigators, supervisors, compliance officers, district or regional personnel, and other FDA personnel regarding technical and scientific matters, inspectional/investigational issues, policies , and laws.

- Gather information on the regulated industry, preventive controls , and industry practice in their major functional area and country/region of assignment .

- Serve as an operational focal point to facilitate the establishment of an auditing and certification program within the host country.

- Work directly with the local or foreign national government to communicate standards and conduct public health systems evaluations.

- Conduct audits that consist of follow-up inspections, and systems audits designed to evaluate the effectiveness of the foreign government's regulatory oversight process and of public and private sector certification processes for helping ensure that exported products meet FDA standards.


QUALIFICATIONS REQUIRED:

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Basic Qualifications for Consumer Safety Officer, GS-0696:

A. Applicant must have at least a Bachelor's degree that includes 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.                       OR

B. Have a combination of education and experience -- courses consisting of at least 30 semester hours in the fields of study described in "A" above, plus appropriate experience or additional education.                                                                                             AND

Candidates must also possess at least one full year of specialized experience at or equivalent to the next lower grade in the federal service.

Additional Qualification Requirements for Consumer Safety Officer, GS-0696-11: A. Applicant must have at least one year of specialized experience, equivalent to at least the GS-09 level in the Federal service, reviewing, gathering and performing standard analysis of scientific data; evaluating scientific data for efficacy and safety; and preparing reports on scientific/technical study findings primarily in foods, feeds, medical devices, clinical trials/research, drugs or biologic .                            OR

Substitution of Education:

B. Applicant must have at least three years of progressively higher level graduate education leading to a Ph.D. degree or Ph.D. or equivalent doctoral degree related to the position being filled. One year of full-time graduate education is considered to be the number of credit hours that the school attended has determined to represent one year of full-time study. If that number cannot be obtained from the school, 18 semester hours will satisfy an academic year of graduate study.                            OR

C. A combination of specialized experience as described in "A" above and education as described in "B" above. When combining education with experience, first determine the applicant's total qualifying education as a percentage of the education required for the grade level; then determine the applicant's experience as a percentage of the experience required for the grade level; finally, add the two percentages. The total percentage must equal at least 100 percent to qualify.

Additional Qualifications for Consumer Safety Officer, GS-0696-12: Applicant must have at least one year of specialized experience, equivalent to at least the GS-11 level in the Federal service   gathering and performing standard analyses of scientific data related to the laws and regulations protecting consumers from products that violate the Food, Drug, and Cosmetic (FD&C) Act and related regulatory policy primarily in foods, feeds, medical devices, clinical trials/research, drugs or biologic s ; ensuring the accuracy and reliability of scientific data included in reports, applications, and/or other scientific documents; preparing reports on scientific/technical study findings and/or delivering presentations to various audiences on scientific or technical data related to enforcement and quality management programs.

Additional Qualifications for Consumer Safety Officer, GS-696-13: Applicant must have at least one year of specialized experience, equivalent to at least the GS-12 level in the Federal service related to the laws and regulations protecting consumers from products that violate of the Food, Drug, and Cosmetic (FD&C) Act and related regulatory policy primarily in foods, feeds, medical devices, clinical trials/research, drugs or biologics; managing regulatory enforcement program activities carried out by subordinate units, such as consumer affairs, enforcement and quality management programs, which directly impact regulated industries.

Additional Qualifications for Consumer Safety Officer, GS-696-14: Applicant must have at least one year of specialized experience, equivalent to at least the GS-13 level in the Federal service providing authoritative guidance on the jurisdictional status of products regulated to Agencies, national, and international organizations in the regulated industry to interpret and implement existing laws, regulations, and management of regulatory enforcement program activities primarily in foods, feeds, medical devices, clinical trials/research, drugs or biologics.


Foreign Education:  If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show that the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program; or full credit has been given for the courses at a U.S. accredited college or university.  For further information, visit: http://www.ed.gov.

Conditions of Employment:

1. Security and Background Requirements:  If not previously completed, a background security investigation will be required for all appointees.  Appointment will be subject to the applicant's successful completion of a background security investigation and favorable adjudication.  Failure to successfully meet these requirements may be grounds for appropriate personnel action.  In addition, if hired, a background security reinvestigation or supplemental investigation may be required at a later time.  Applicants are also advised that all information concerning qualifications is subject to investigation.  False representation may be grounds for non-consideration, non-selection and/or appropriate disciplinary action.

2. E-Verify:  If you are selected for this position, the documentation that you present for purposes of completing the Department of Homeland Security (DHS) Form I-9 will be verified through the DHS "E-Verify" System.  Federal law requires DHS to use the E-Verify System to verify employment eligibility of all new hires, and as a condition of continued employment obligates the new hire to take affirmative steps to resolve any discrepancies identified by the system.  The U.S. Department of Health and Human Services is an E-Verify Participant.

3. Direct Deposit:  All Federal employees are required to have Federal salary payments made by direct deposit to a financial institution of their choosing.

4. All qualification requirements must be met by the cut-off or closing date of the announcement.

5. Financial disclosure statement may be required. Certain positions within FDA are subject to restrictions on financial holdings specifically FDA regulated financial holdings.  This position could be subject to these restrictions.  During the application and interview process, and prior to accepting this position, we advise applicants to seek additional information from the FDA Ethics Office at (301) 827-5511.

6. One-year probationary period may be required.

7. Travel, transportation, and relocation expenses will be paid. Yes

8. Bargaining Unit Position: No

9. Drug Screening Required: No

10. Recruitment incentives may be authorized: No

11. Student loan repayment incentive may be authorized.

12. Annual leave for non-federal service may be authorized.

HOW YOU WILL BE EVALUATED:

Once the application process is complete, a review of the resume and supporting documentation will be made and compared against your responses to the assessment questionnaire to determine if you are qualified for this job.  If, after reviewing your resume and/or supporting documentation, a determination is made that you have inflated your qualifications and/or experience, you may lose consideration for this position.  Please follow all instructions carefully.  Errors or omissions may affect your eligibility.  Category rating procedures will be used to rate and rank candidates.  The category assignment is a measure of the degree in which your background matches the competencies required for this position.  Qualified candidates will be ranked into one of three categories:  Best Qualified, Well Qualified or Qualified.

The Category Rating Process does not add veterans' preference points but protects the rights of veterans by placing them ahead of non-preference eligibles within each category.  Preference eligibles who meet the minimum qualification requirements and who have a compensable service-connected disability of at least 10 percent must be listed in the highest quality category (except in the case of scientific or professional positions at the GS-9 level or higher).  Your qualifications will be evaluated on the following competencies (knowledge, skills, abilities and other characteristics):

1. Knowledge of Food, Drug and Cosmetic Act, its regulations and policies, inspectional manuals and guidance to serve as an authority with internal and external customers primarily in foods, feeds, medical devices, clinical trials/research, drugs or biologics.  

2. Skilled in analyzing and interpreting inspectional and analytical data concerning foods, feeds, medical devices, clinical trials/research, drugs or biologics.

3. Ability to communicate orally and in writing on a wide range of issues that are often highly complex.

4. Ability to conduct   foreign inspections, particularly including functioning as lead inspector on international inspections.

5. Skilled in communicating orally and in writing regarding federal public health regulatory matters.


BENEFITS:

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The Federal Government offers a comprehensive benefits package.  Explore the major benefits offered to most Federal employees at http://www.usajobs.gov/ResourceCenter/Index/Interactive/Benefits#icc.



OTHER INFORMATION:

If you are a veteran with preference eligibility and you are claiming 5-points veterans' preference, you must submit a copy of your DD-214 or other proof of eligibility.  If you are claiming 10-point veterans' preference, you must also submit an SF-15, "Application for 10-Point Veterans' Preference" plus the proof required by that form.  For more information on veterans’ preference see http://www.usajobs.gov/Veterans.

Males born after December 31, 1959 must be registered or exempt from Selective Service (see http://www.sss.gov).

For information on "People with Disabilities" please visit http://opm.gov/disability/PeopleWithDisabilities.asp

Interagency Career Transition Assistance Program (ICTAP):  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.



HOW TO APPLY:

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To begin the process, click the Apply Online button to create an account or log in to your existing USAJOBS account.  Follow the prompts to complete the assessment questionnaire.  Please ensure you click the Submit My Answers button at the end of the process.

Note:  To return to a previously Saved or Incomplete application you may use the following link: https://applicationmanager.gov.

To fax supporting documents you are unable to upload, complete this cover page http://staffing.opm.gov/pdf/usascover.pdf using the following Vacancy ID 792594.  Fax your documents to 1-478-757-3144.

If you cannot apply online:

  1. Click the following link to view and print the assessment questionnaire View Occupational Questionnaire, and
  2. Print this 1203FX form to provide your response to the assessment questionnaire http://www.opm.gov/forms/pdf_fill/OPM1203fx.pdf and
  3. Fax the completed 1203FX form along with any supporting documents to 1-478-757-3144.  Your 1203FX will serve as a cover page for your fax transmission.
  4. This agency provides reasonable accommodation to applicants with disabilities.  If you need a reasonable accommodation for any part of the application and hiring process, please contact the Bethesda Customer HelpDesk at (888) 478-4340; TTY/TDD: (800) 877-8339; or by email quickquestions@fda.hhs.gov.  The decision on granting reasonable accommodation will be made on a case-by-case basis.


REQUIRED DOCUMENTS:

To apply for this position, you must provide a complete Application Package which includes:

  1. Your Résumé - You are encouraged to use the USAJobs online resume builder to ensure that all required information is in your resume.  If you use your own résumé, curriculum vitae, or any other written form you choose then you must describe your job-related qualifications that include beginning and ending dates for paid and non-paid work experience, hours worked per week, month and year of employment for each job title listed.

  2. A complete Assessment Questionnaire

  3. Other supporting documents:

  4.      - Veterans Preference Documentation, if applicable

         - College Transcripts (if the position has a positive education requirement)

For Résumé and Application Tips visit: http://www.usajobs.gov/ResourceCenter/Index/Interactive/ResumeAndApplicationTips#icc

The complete Application Package must be submitted by 11:59 PM (EST) on Monday, August 19, 2013.

AGENCY CONTACT INFO:

FDA Helpdesk
Phone: (888)478-4340
Fax: (478)757-3144
Email: QUICKQUESTIONS@PSC.GOV
Agency Information:
HHS FDA Center
10903 New Hampshire Avenue
Silver Spring, MD
20993 Fax: (478)757-3144

WHAT TO EXPECT NEXT:

Once the online questionnaire is received you will receive an acknowledgement email that your submission was successful.  The most highly qualified candidates will be referred to the hiring manager for further consideration and possible interview.  We expect to make a selection within 45 days of the closing date of this announcement.

You will receive notice via email or by mail, if no email address was provided by you during the application process, once this process is completed (generally 4-6 weeks).

Additional Duty Location Info

Many vacancies in the following locations:
Guangzhou ChinaView Map
New Delhi IndiaView Map
Beijing ChinaView Map
Mumbai IndiaView Map
Shanghai ChinaView Map
Mexico City MexicoView Map
Hyderabad IndiaView Map

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Job Announcement Number:

HHS-FDA-OC-DE-13-792594

Control Number:

331966900