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 (Quality Program Specialist)

Department:Department Of Health And Human Services

Agency:Food and Drug Administration

Job Announcement Number:HHS-FDA-DE-13-828327

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

The contents of the announcement can still be viewed.

SALARY RANGE:

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

OPEN PERIOD:

Monday, January 28, 2013 to Wednesday, February 06, 2013

SERIES & GRADE:

GS-0696-12/13

POSITION INFORMATION:

Full Time - Permanent

PROMOTION POTENTIAL:

13

DUTY LOCATIONS:

1 vacancy in the following location(s):
Parsippany, NJ United StatesView Map
Baltimore Metro Area, MD United States

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 Regulatory Affairs (ORA), Office of Communication and Quality Program Management, located in Parsippany, NJ and Baltimore, MD.


This vacancy is also being announced concurrently with vacancy announcement HHS-FDA-MP-13-828654 under merit promotion procedures.  Please review that announcement to see if you are eligible for consideration under merit promotion procedures.  NOTE:  Applicants must apply separately for each announcement in order to be considered.

Who May Apply:  Open to all United States Citizens.

PHS Commissioned Corps Officers interested in performing the duties of this position within the Commissioned Corps (not as a career/career-conditional employee) are encouraged to apply under the merit promotion announcement indicated above.

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

KEY REQUIREMENTS

  • U.S. Citizenship is required.
  • Background investigation required.
  • Must obtain certification through the American Society for Quality (ASQ).

DUTIES:

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The Quality Program Specialist (QPS) will be responsible for performing audits and assessments of all Office of Regulatory Affairs (ORA) processes and services determining the fitness for use of these products.  These products will be used in legal cases against firms that manufacture FDA regulated products.  The incumbent will evaluate and coordinate all proposed legal actions to ascertain compliance with regulatory policy objectives.  They will have access to confidential information relative to injuries and illness imposed upon the American public by regulated products which must be coordinated with high level of sensitivity and confidentiality.  The employee will operate the quality systems program and may provide testimonial information to legal officials as to the work of FDA in congressional inquiries. 

The employee will provide direction and counsel to ORA Management and officials in the implementation of policies, and operational guidelines that form the framework for quality systems management for ORA.  In addition, they will advise and assist the Associate Commissioner for Regulatory Affairs (ACRA) and other key officials on regulations that have an impact on policy development and execution of long-range program goals.  They will coordinate, interpret, and evaluate ORA's overall quality efforts in additions to establishing policy and recommending policy to the ACRA.  

Develops programs to insure that quality control/assurance programs provision are planned, developed and implemented to identify, prevent and correct unsatisfactory conditions and elements which influence the regulatory correctness and responsiveness of transactions and services. The QPS establishes quality program management strategies and techniques to fit operations, culture and interest of Headquarters management and staff.  The employee also develops policy guidance, motivational materials and information to facilitate participation in important program initiatives in accordance with the ORA Quality Manual, ISO standards, and ASQ guidelines. 

Employee further develops reporting procedures sampling techniques, and measurements at various points in the transaction process or business cycle to identify problem areas or inherent weaknesses in work processes, procedures, information systems and content.  QPS also develops indicators to provide objective evidence of the effectiveness of quality procedures and controls and for complex transactions or business processes.  

 

Must obtain certification through the American Society for Quality (ASQ) during the first year of employment in this position.

 


QUALIFICATIONS REQUIRED:

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Basic Qualification:

 

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.

 

OR


B. 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.

 

Additional Qualification Requirements for Consumer Safety Officer (Quality Program Specialist)

 

GS-0696-12.

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. 

 

Additional Qualification Requirements for Consumer Safety Officer (Quality Program Specialist)

 

GS-0696-13.

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.

 

 

 



 


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 closing date of the announcement.

 

5. Financial disclosure statement may be required.

 

6. One-year probationary period may be required.

 

7. Travel, transportation, and relocation expenses will be paid: No

 

8. Bargaining Unit Position: No

 

9. Drug Screening Required: No

 

10. Recruitment incentives may be authorized: No

 

11. Student loan repayment incentive authorized: No

 

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

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 the Food, Drug, and Cosmetic Act rules and regulations.

2. Skill in selecting, adapting and applying investigative methods and negotiating techniques.

3. Knowledge of the principles, practices and theories of quality control and quality assurance programs.

4. Ability to communicate well both verbally and in writing.


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 828327.  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)
                       - Individuals with Disabilities (must submit proof on the organization's letterhead), if applicable
                          For Sample letter: http://www.fda.gov/downloads/AboutFDA/WorkingatFDA/UCM276860.pdf.

 

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 Wednesday, February 06, 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).


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Job Announcement Number:

HHS-FDA-DE-13-828327

Control Number:

336050900