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

Job Title:Program Analyst, GS-0343-12/13

Department:Department Of Health And Human Services

Agency:Food and Drug Administration

Job Announcement Number:HHS-FDA-ORA-MP-12-746168

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

The contents of the announcement can still be viewed.


$74,872.00 to $115,742.00 / Per Year


Wednesday, September 19, 2012 to Wednesday, October 10, 2012




Full Time - Permanent




2 vacancies in the following location(s):
Rockville, MD United StatesView Map
Chicago Metro Area, IL United States


Status Candidates (Merit Promotion and VEOA Eligibles)


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.

Who May Apply:  Federal employees with career or career-conditional appointments in the competitive service; former Federal employees with reinstatement eligibility based on previous career or career-conditional appointments; displaced Federal employees requesting special priority selection consideration under the Career Transition Assistance Plan (CTAP) and the Interagency Career Transition Assistance Program (ICTAP); veterans who are preference eligibles or who have been separated under honorable conditions after 3 years or more of continuous active service; Military Spouses; PHS Commissioned Corps Officers;and individuals with disabilities.



This position is located in the Department of Health and Human Services, Food and Drug Administration (FDA),  Office of Regulatory Affairs (ORA), Quality Management Systems, located in either Rockville, MD or Chicago, IL.


This vacancy is also being announced concurrently with vacancy announcement HHS-FDA-ORA-DE-12-733898 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.

This announcement may be used to fill multiple positions in multiple locations.


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.


  • U.S. Citizenship is required.


Back to top


The Program Analyst (Quality Program Specialist) is a Headquarter's position reporting to the Director, Quality Management systems within the Office of Regulatory Affairs.  The incumbent may be located in Field Offices serving in a staff advisory role to one or more District Directors carrying out diverse responsibilities related to the administrative and technical aspects of the quality Management System (QMS) in fulfilling the scientific and regulatory, investigative, and/or compliance mission of FDA ORA District Office Nationwide.  The mission of the organization is protecting consumers and enhancing public health by maximizing compliance of FDA regulated products and minimizing risk associated with those products.



The analyst conducts studies of programs within an assigned major administrative, professional, operational, or scientific quality unit within the ORA.  The purpose of the program studies and analyses is to improve the efficiency and effectiveness of organizational structures, to assess organizational and program problems and recommended solutions, and to review and evaluate the potential effectiveness of proposed organizations and programs.  Further the Quality System Manager is responsible for maintaining consistency and uniformity with other quality units, as well as their units' adherence to core operating procedures.


The analyst gathers and organizes information from variety of sources such as records, computer files, previous studies, and interviews, analyses information to identify issues and isolate problems, develops solutions and measurement of productivity and effectiveness for use by others, develops detailed briefings and reports of findings and recommendations, an convinces others to implement recommendations.


The planning, organization and conduct of studies is complicated by such factors as conflicting programs goals and objectives, difficulty in obtaining accurate, measurable data, changes in legislation, changes in organizational mission and structures of programs studied and related programs within the ORA and in other center/offices, the need to evaluate and develop recommendations to improve programs which may be carried out by a variety of organizations with varying objectives, regulations, policies, and procedures, and the need to consider how each program studied interacts with other ORA organizations, State and local government, or the regulated industry.



As a senior Program Analyst, the incumbent conducts major, and/or long-term studies of the mission programs and operations carried out by all ORA organizations, and/or implements major planning, evaluation or monitoring processes, develops long/short range /programmatic/ operational plans and budgets, and conducts scheduled surveys, program studies, and specials studies in any or all organizations.  These studies regularly involve critical, sensitive, and/or controversial issues that affect the way the Agency carries out statutory responsibilities and/or the way the regulated industry interacts with the Agency.  The analyst is required to be fully knowledgeable of FDA and ORA -wide mission, functions, organizations, methods, and procedures.  Scope and analytical work extends to include review, analysis, and recommendations for improvement in the way in which major ORA programs are carried out.  Implements and evaluates recommendations adopted, when requested.


Plans and conducts comprehensive analytical surveys and special studies acting as the team leader when other analysts are involved.  Confers with operating officials and supervisors to discuss survey requirements.  Presents and discusses findings with responsible officials and documents findings in written management reports, identifying weaknesses and outlining conclusions, analyzing findings and making specific recommendations for resolution of problem areas, substantially increasing program effectiveness.


Back to top


Minimum Qualification Requirements for Program Analyst, GS-0343-12. 

Applicants must have one year of specialized experience, equivalent to the GS-11 grade level in the Federal service conducting detailed analyses of complex functions and work processes of broad administrative or technical programs and makes recommendations for improvement in the effectiveness and efficiency of work operations. 


Minimum Qualification Requirements for Program Analyst, GS-0343-13.


Applicants must have one year of specialized experience, equivalent to the GS-12 grade level in the Federal service analyzing and evaluating on a quantitative or qualitative basis the effectiveness of a broad/complex program operation; conducting studies of organizational efficiency and productivity and recommending changes or improvements in organizations.


Documenting experience:  In accordance with Office of Personnel Management policy, federal employees are assumed to have gained experience by performing duties and responsibilities appropriate for their official series and grade level as described in their position description.  Experience that would not normally be part of the employee's position is creditable, however, when documented by satisfactory evidence, such as a signed memorandum from the employee's supervisor or an SF-50 or SF-52 documenting an official detail or other official assignment. The documentation must indicate whether the duties were performed full time or, if part time, the percentage of times the other duties were performed. It is expected that this documentation is included in the employee's official personnel record. In order to receive credit for experience in your resume that is not within the official series and grade level of your official position, you must provide a copy of the appropriate documentation of such experience as indicated above.


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 date of the announcement.


5. Financial disclosure statement may be required. Certain positions within the 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 applicantsd to seek additional information from the FDA Ethics Office at (301) 827-5511.


6. One-year probationary period may be required.


7. Moving Expenses Authorized: Yes


8. Bargaining Unit Position: No


9. Drug Screening Required: No


10. Recruitment/Relocation incentives may be authorized: No


11. Time in grade (TIG) must be met within 30 days of the closing date of the announcement.


12. Student loan repayment incentive authorized: No


13. Annual leave for non-federal service authorized: No


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.


Your qualifications will be evaluated on the following competencies (knowledge, skills, abilities and other characteristics):


1. Knowledge and skill sufficient to plan, schedule and conduct projects and studies to evaluate, identify, and resolve issues and problems.


2. Ability to conduct qualitative and quantitative studies. 


3. Ability to communicate orally and in writing.


Back to top

The Federal Government offers a comprehensive benefits package.  Explore the major benefits offered to most Federal employees at


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


Males born after December 31, 1959 must be registered or exempt from Selective Service (see


For information on "People with Disabilities" please visit


Interagency Career Transition Assistance Program (ICTAP):  For information on how to apply as an ICTAP eligible see  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.


Back to top

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:


To fax supporting documents you are unable to upload, complete this cover page using the following Vacancy ID 746168.  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 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 HelpDesk at (888) 478-4340; TTY/TDD: (800) 877-8339; or by email  The decision on granting reasonable accommodation will be made on a case-by-case basis.


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

         - SF-50 (if you are a federal employee or have reinstatement rights as a federal employee)

         - PHS Commissioned Corps Officer must submit a copy of latest personnel order

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


Note:  You may submit an unofficial transcript or a list of college courses completed indicating course titles, credit hours, and grades received.  An official transcript from an accredited educational institution is required if you are selected for the position.


For Résumé and Application Tips visit:


The complete Application Package must be submitted by 11:59 PM (EST) on Wednesday, October 10, 2012


Bethesda Center Helpdesk
Phone: (888)478-4340
Fax: (478)757-3144
Agency Information:
OHR Bethesda Operations Center
7700 Wisconsin Ave
Bethesda, MD
20814 Fax: (478)757-3144


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).

Back to top
Print Preview

Job Announcement Number:


Control Number: