United States Citizens Permanent Full Time
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.
The FDA''s Office of Regulatory Affairs is the lead office for all FDA Field activities as well as providing FDA leadership on imports, inspections and enforcement policy. ORA supports FDA Product Centers by inspecting regulated products and manufacturers, conducting sample analysis on regulated products, and reviewing imported products offered for entry into the United States. ORA also develops FDA-wide policy on compliance and enforcement.
This vacancy is also being announced concurrently with vacancy announcement **FDA-ORA-14-MP-1152463-WW**under competitive procedures. Please review that announcement to see if you are eligible for consideration under competitive procedures. **NOTE:** Applicants must apply separately for each announcement in order to be considered.
**Who May Apply:** Open to all United States Citizens.
**LOCATION:** This position is located in the Department of Health and Human Services (DHHS), Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA). Duty station will be determined upon selection.
The salary listed in the vacancy announcement is at the base level. The geographical locality pay will be determined at the time of selection. ****TYPE OF POSITION:**** This position is being filled on a full-time, permanent basis.
**PROMOTION POTENTIAL:** This is a career-ladder position; GS-12 is the full performance level.
This announcement may be used to fill multiple positions in multiple locations within Food and Drug Administration (FDA).
U.S. Citizenship required. All application materials must be received by the closing date. Please carefully read and follow the instructions for HOW TO APPLY. Suitability for Federal employment determined by background investigation Mobility agreement required Government passport required Physical Ability agreement required
This position is located in an FDA District Office or Resident Post. As an import, domestic, or foreign investigator, the Consumer Safety Officer is recognized for competence in ensuring that drug and related health product manufacturing, packaging, and testing sites comply with Federal manufacturing and quality standards. The purpose of this position is to plan and conduct inspections, investigations, sample collection, and related activities; provide training to new personnel, higher graded personnel, and other government personnel; and when required, conduct international inspections. At the full performance level, major duties include:
* Conducts domestic and international inspections and investigations where limited guidance is available, where proposed or new regulations must be used for evaluations, or where the inspection or investigation could be the subject of attention by the media, Congress, or other entities.
* Conducts the complex, technical investigations and inspections of establishments and prepares final EIR, investigation memoranda, and proposed or final endorsements. Reports are developed and in most instances accepted with little or no review of format or content.
* Performs investigations involving complaints and traceback investigations of injury or death attributable to health products regulated by the FDA. Investigations of injuries require special coordination and a high degree of insight and knowledge.
* Trains lower level investigators in sophisticated inspection and investigation techniques and designs agendas for and participates as an instructor in training programs for district and industry personnel and may mentor lower graded personnel to insure that they receive the correct mix of formal and on-the-job training.
In addition to meeting the educational requirements, applicants must meet all qualification requirements by the closing date of this vacancy announcement:
**Specialized Experience:** Specialized experience is experience that equipped the applicant with the particular knowledge, skills and abilities to perform successfully the duties of the position that is typically in or related to the work of the position to be filled.
**GS-11**: Have at least one year of specialized experience, equivalent to at least the GS-09 level in the Federal service, conducting analyses of scientific data; reviewing and evaluating scientific data for efficacy and safety; preparing reports on scientific/technical study findings to ensure regulatory compliance involving manufacturing of pharmaceuticals (human or veterinary); investigating and inspecting domestic establishments for drug compliance; commensurate experience with drug audits, specifically GMP compliance; **OR** a Ph.D. or equivalent doctoral degree or three full years of progressively higher level graduate education leading to such a degree or LL.M., if related; or a combination of the required experience and education for this grade level.
**GS-12:**Have at least one year of specialized experience, equivalent to at least the GS-11 level in the Federal service, developing, implementing, monitoring and evaluating drug manufactoring processes and control; providing advice and guidance on scientific and regulatory drug standards and policies involving manufacturing of pharmaceuticals (human or veterinary); independently investigating and inspecting domestic establishments for drug compliance; is endorsed for or has experience conducting foreign drug inspections.
**SUBSTITUTION OF EDUCATION:** Substitution of education for specialized experience will be made in accordance with the OPM Operating Manual, Qualification Standards for General Schedule Positions. Employees who are substituting education for experience must upload a copy of unofficial or official transcripts prior to the announcement closing. Selectees will be required to provide official transcripts upon selection.
**Note:** One year of full-time graduate education is considered to be the number of credit hours that the school you attended has determined to represent one year of study. If this information cannot be obtained from your school, we will consider 18 semester/27 quarter hours to be equal to one year of full-time study.
Experience and education as described above may be combined to meet the minimum qualification requirements. Experience and education should be computed as percentages of the overall requirements and must equal to 100 percent when combined.
This position has an education requirement. You must submit a copy of your transcripts (or a list of your courses including titles, credit hours completed and grades) to document that you have met the education requirement. Unofficial transcripts will be accepted in the application package; however, official transcripts will be required prior to beginning employment. Most colleges and universities offer unofficial transcripts online. Please check your school website to obtain a copy quickly.
To qualify, applicants must have successfully completed one of the following:
**For Consumer Safety Officer, GS-0696:**
**A. Degree:** which 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 provide 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 includes principles, theory, or practical application of computers or computer programming;
****OR****
**B.** Combination of education and experience: courses consisting of at least 30 semester hours in the fields of study as described in "A" above, plus appropriate experience or additional education. The quality of the combination of education and experience must be sufficient to demonstrate possession of knowledge directly related to consumer safety officer work and is comparable to that normally acquired through the successful completion of a full four year course of study with a major in the appropriate fields.
**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.
**All qualification requirements must be met by 11:59 PM (Eastern Time) on the closing date of this vacancy announcement.**
Failure to provide any of the above will result in an ineligible rating.
**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 closing of the announcement.
5. Pre-employment physical required: No
6. Drug testing required: No
7. Recruitment Incentive authorized: No
8. Student loan repayment incentive authorized: No
9. Annual leave for non-federal service authorized: No
10. Bargaining Unit Position: Yes
11. Probationary Period: May be required to serve a one-year probationary period.
12. Please be advised that this position may be subject to FDA''s strict prohibited financial interest regulation and therefore, may require the incumbent of this position to divest of certain financial interests. Applicants are strongly advised to seek additional information on this requirement from the FDA hiring official before accepting this position.
Once the job opportunity announcement closes, a review of your résumé 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 résumé and supporting documentation, a determination is made that you have inflated your responses when compared to your background information, your score may be adjusted to more accurately reflect your skills and abilities.
**Please follow all instructions carefully. Errors or omissions may affect your eligibility.**
Qualified candidates will be assigned to the following quality categories:
* Best Qualified - Applicants who have experience that is almost identical to those required by the position.
* Well Qualified - Applicants who have experience that is very similar to those required by the position.
* Qualified - Applicants who meet minimum qualification requirements, but do not identify any additional qualifying experience or skill.
The category assignment is a measure of the degree in which your background matches the required competencies listed below for this position.
1. Knowledge of pertinent laws, regulations, policies, precedents, program goals and objectives.
2. Skill in selecting, adapting, and applying investigative methods and negotiating techniques.
3. Ability to communicate orally.
4. Ability to communicate in writing.
Application of Veterans'' Preference: Under Category Rating procedures, veteran preference eligibles will receive selection consideration before non-preference eligibles within each quality category.
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).
The complete application package must be submitted by 11:59 PM (EST) onWednesday, July 30, 2014.
* To begin, click **Apply Online** to create aUSAJOBS account or log into your existing account. Follow the prompts to select your USAJOBS resume and/or other supporting documents to upload your documents and complete the occupational questionnaire.
* Click the **Submit My Answers** button to submit your application package.
* It is your responsibility to ensure your responses and appropriate documentation is submitted prior to the closing date.
* To verify your application is complete, log into yourUSAJOBS account, select the **Application Status**link and then select the **More Information**link for this position. The _Details_ page will display the status of your application, the documentation received and processed, and any correspondence the agency has sent related to this application.
**NOTE** : Your uploaded documents may take several hours to clear the virus scan process.
* To return to an incomplete application, log into yourUSAJOBS account and click **Update Application**in the vacancy announcement. You must re-select your resume and/or other documents from your USAJOBS account or your application will be incomplete.
**NOTE:** If you applied online and your application is complete, **do not** fax the paper application (1203FX) as this will overwrite your prior online responses and may result in an ineligible rating.
To fax supporting documents you are unable to upload, complete theUnited States Government Application Cover Page using the following Vacancy ID: 1153528. Fax your documents to **1-478-757-3144**.
**If you cannot apply online:**1. View and print the occupational questionnaire: View Occupational Questionnaire
2. Print the1203FX (Form C) to provide your responses to the occupational questionnaire; and
3. Fax the completed 1203FX and supporting documents to **1-478-757-3144**. Your 1203FX will serve as a cover page for your fax transmission.
Due to our security procedures, our office will not accept any applications submitted via email or standard mail. The email address is listed only for inquiries about the position or the _How to Apply_ process.
To apply for this position, you must provide a complete Application Package which includes:
1. Your **Résumé** - You are encouraged to use theUSAJobs 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 (only submit if applicable to you):**
* SF-50 (if you are a federal employee or have reinstatement rights as a federal employee). The SF-50 must include your position, title, series, grade, step, tenure, type of service (Competitive or Excepted) and career status (career or career-conditional).
* College Transcript (s) must meet the basic requirement as noted in the qualification section of this job announcement. (if qualifying all or in part based on your education).
* Veterans'' Preference documentation (i.e. SF-15, DD-214, Statement of Service, Service Connected Disability Letter, etc.)
* CTAP/ICTAP documentation (Copy of Separation Notice, SF-50, current performance evaluation)
For Résumé and Application Tips visit:http://www.usajobs.gov/ResourceCenter/Index/Interactive/ResumeAndApplicationTips#icc.
All supporting documentation must be received by the closing date of the vacancy announcement to claim certain types of preference or qualify on the basis of education.
**PROOF OF EDUCATION:** Applicants must submit a copy of their transcripts with the course title, number of credits, grade, and date of completion. To qualify, the degree or certificate must be from an accredited college or university, or qualifying career or certificate program. Education completed in a foreign institution must be certified as equivalent to coursework completed at a U.S. college or university. Certification of equivalency must be submitted at the time of application.
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).
The Federal Government offers a comprehensive benefits package. Explore the major benefits offered to most Federal employees at:https://help.usajobs.gov/index.php/Main_Page.
**VETERANS'' PREFERENCE:** If you are claiming veterans'' preference under competitive procedures, you must submit a copy of your military discharge certificate (**DD 214 member 4 copy**), official statement of service from your command if you are currently on active duty, or other proof of eligibility. To be acceptable, the document must show Character of Service. If you are claiming 10-point veterans'' preference, you must also submit an Application for 10-Point Veterans'' Preference (SF 15) and the required documentation specified on the reverse of the SF 15. Preference will be granted based on the documents received. For more information visithttp://www.opm.gov/veterans/html/vetguide.asp
**Career Transition Program:** This program applies to Federal workers whose positions have been deemed ''surplus'' or no longer needed, or an employee has been involuntarily separated from a Federal service position within the competitive service. 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. For information on how to apply and what documents to submit as a CTAP/ICTAP eligible, go to: **www.opm.gov/rif/employee_guides/career_transition.asp**** .**
**Selective Service:**The Defense Authorization Act of 1986 requires that all male applicants born after 12/31/59 who are required to register under the Military Selective Service Act, be registered or they are not eligible for appointment to this position. For further information concerning Selective Service requirements, please visithttp://www.sss.gov/ .
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 Center HelpDesk (888) 478-4340; TTY/TDD: (866) 539-4484; or by email quickquestions@fda.hhs.gov. The decision on granting reasonable accommodation will be made on a case-by-case basis.