Consumer Safety Officer - Silver Spring, MD

Vacancy No.

PH-BM-301822-COMP/MP

Department

Food and Drug Administration (FDA)

Salary

$41,210.00 to $79,280.00

Grade

07 to 11

Perm/Temp

Permanent

FT/PT

Full-time

Open Date

12/9/2009

Close Date

12/30/2009

Job Link

Apply Online

Who may apply

Public

Locations: ( Help make everyone's job search easier! Report incorrect job locations. Include a new Location)

SILVER SPRING, MD remove

 

Job Description (Please follow all instructions carefully)

Department:
Department Of Health And Human Services
Agency:
Food and Drug Administration
Job Announcement Number:
PH-BM-301822-COMP/MP
Job Title:
Consumer Safety Officer
Salary Range:
41,210.00 - 79,280.00 USD /year
Series & Grade:
GS-0696-07/11
Promotion Potential:
13
Open Period:
Wednesday, December 09, 2009 to Wednesday, December 30, 2009
Position Information:
Full Time Career/Career Conditional
Duty Locations:
many vacancies - Silver Spring, MD
Who May Be Considered:
US Citizens and Status Candidates
Job Summary:
Become a part of the Department that touches the lives of every American! At the Department of Health and Human Services you can give back to your community, state, and country by making a difference in the lives of Americans everywhere. Join HHS and help to make our world healthier, safer and better for all Americans.

  • Do you want assist in evaluating medical devices and radiation-emitting products
  • Are you interested in ensuring that the public is safe when using ionizing and non-ioninzing radiation-emitting products.

One or more positions may be filled using this vacancy announcement.
Commissioned Corps Officers in the Public Health Service and "qualified" commissioned corps candidates may be considered for internal placement provided they submit a cover letter indicating commissioned corps status, a current resume or curriculum vitae, and provide all other required information specified in the vacancy announcement.


Key Requirements:

  • You must be a U.S. Citizen or National.
  • Resume and supporting documents (See How To Apply section)


Major Duties:

The incumbent serves as a Consumer Safety Officer carrying responsibilities to support the enforcement of  Medical Device Amendments of 1976 including the Safe Medical Device Act of 1990 and 1992, the Radiation Control for Health and Safety Act of 1968.   Specific duties performed:

 

  • Participates in the review and evaluation of evidence for legal and administrative actions, recalls, and premarket approval clearance for medical devices and/or radiological products.
  • Provides reports of findings in support of case development and activities, related to legal and administrative actions.
  • Reviews, evaluate and respond to a variety of inquiries involving the FD&C Act.
  • Communicates current policies and/or interprets questions regarding compliance activities or submission.
  • Plans and coordinates investigations.


Qualifications:

BASIC QUALIFICATION REQUIREMENTS FOR ALL GRADES

A.  You must have 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. You must 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.

 

ADDITIONAL REQUIREMENTS

 

To qualify for  a GS-07 Consumer Safety Officer, you must have one of the following:

 

A. 1 year (18 semesters hours or equivalent) of graduate-level education in a field that demonstrates the knowledge, skill, and ability to perform the duties of this position.  OR

 

B.  Possess an undergraduate degree as described in BASIC REQUIREMENTS above and meet one of the requirements for Superior Academic Achievement (SAA) as follows: 1) Class standing – Graduated in the upper third of the class based on completed courses in the college, university or major subdivision; 2) Grade Point Average – 2.95 or higher out of a possible 4.0 scale as recorded on official transcript, or as computed based on 4 years of education, or as computed based on courses completed during the final 2 years of the curriculum; or 3.5 or higher on a 4.0 scale based on the average of the required courses completed in the major field or the required courses in the major field completed during the final 2 years of curriculum; or 3) Election to membership in a national scholastic honor society.  OR

 

C. Possess at least one year of specialized experience equivalent to the GS-05 level in the Federal service or equivalent pay systems,  assisting in performing reviews and evaluations of data to determine lack of compliance;  or assisting/performing  evaluations of evidence for legal and administrative action recommendations, recalls, and premarket approval clearance for medical devices and or radiological products.  OR

 

To qualify for GS-09 Consumer Safety Officer, you must have one of the following:

 

A. Possess at least one year of specialized experience equivalent to the GS-07 level in the Federal service or equivalent pay systems, independently performing reviews and evaluations of data to determine lack of compliance; or participating as team member in evaluations of evidence for legal and administrative actions recommendations, recalls and premarket approval clearance for medical devices and/or radiological products; including providing reports of findings in support of case development and activities related to legal and administrative actions.   OR

 

B. Possess two years (36 semester hours or equivalent) of progressively higher level graduate education leading to a master's degree or master's or equivalent graduate degree in a field that demonstrates the knowledge, skill, and ability to perform the duties of this position.

 

To qualify for GS-11 Consumer Safety Officer, you must have one of the following:

 

A.  One year of specialized experience equivalent to the GS-9 or higher grade level in the Federal service, independently reviewing and evaluating evidence for legal and administrative action recommendations, recalls and premarket approval clearance for medical devices and/or radiological products; or  providing documentation support for case development and coordinating activities related to legal and administrative actions and developing or coordinating responses to requests for guidance and interpretation of the FD&C Act.   OR

 

B. Completed 3 years (54 semester hours or equivalent) of progressively higher level graduate education leading to a Ph.D. degree or Ph.D. or equivalent doctoral degree in a related scientific field that provided me with the knowledge, skills, and abilities necessary to perform the duties of this position.

 

SUBSTITUTION OF EDUCATION FOR EXPERIENCE

 

Graduate level education may be substituted for specialized experience based on the following computation:  First determine your total qualifying education as a percentage of the education required for the grade level; then determine your 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 an applicant for that grade level.

 

 

 

ARE YOU USING YOUR EDUCATION TO QUALIFY? You MUST provide transcripts or other documentation to support your educational claims.  Unless otherwise stated: (1) unofficial transcripts are acceptable, or (2) you may submit a list with all of your courses, grades, semester, year, and credit for the course. All materials must be submitted by the closing date of the announcement.

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/about/offices/list/ous/international/usnei/us/edlite-visitus-forrecog.html

 

Only experience obtained by the closing date of this announcement will be considered.

Status candidates must meet time-in-grade requirements (52 weeks at the next lower grade level).


How You Will Be Evaluated:

Once the application process is complete, a review of your 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. The numeric rating you receive is based on your responses to the questionnaire. The score is a measure of the degree to which your background matches the knowledge, skills, and abilities required for this position.  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 rating. Your qualifications will be evaluated on the following competencies (knowledge, skills, abilities and other characteristics):

  • ABILITY TO EFFECTIVELY ACQUIRE AND EVLUATE SCIENTIFIC, ENGINEERING, AND MANUFACTURING (PROCESS) INFORMATON  AS APPLIED TO MEDICAL DEVICE AND/OR RADIOLOGICAL HEALTH.
  • SKILL IN THE USE OF ANALYTICAL AND SCIENTIFIC APPROACHES IN RESOLVING STRAIGHTFORWARD ISSUES OR PROBLEMS.
  • KNOWLEDGE OF POLICIES, ISSUES GOALS OF THE OFFICE OF COMPLIANCE AND OTHER DIVISIONS WITHIN THE FDA.
  • SKILL IN EFFECTIVE WRITTEN AND ORAL COMMUNICATONS TO PREPARE AND DELIVER BRIEFINGS, PAPERS, AND COMPLIANCE DOCUMENTS


Benefits:

The Federal government offers a number of exceptional benefits to its employees. This link provides an overview of the benefits currently offered to Federal employees. http://www.usajobs.opm.gov/ei61.asp


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/veteranscenter

Males born after 12-31-59 must be registered or exempt from Selective Service (see www.sss.gov ).

Interagency Career Transition Assistance Program (ICTAP): For information on how to apply as an ICTAP eligible see http://www.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 or above on the rating criteria for this position.


How To Apply:

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

1. Your Résumé
2. A complete Assessment Questionnaire
3. Other supporting documents:
         - Veterans Preference Documentation, if applicable 
         - College transcript(s), if qualifying based on education
         - SF-50, Notification of Personnel Action (if applying as a status candidate with current or 
           former Federal service)

The complete Application Package must be submitted by 11:59 PM (EST) on Wednesday, December 30, 2009.

To begin the process, click the Apply Online button at the bottom of this screen 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: PH301822.   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/pdfimage/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.


Required Documents:

The following documents are required and must be received by the closing date of this announcement:

1. Your Résumé
2. A complete Assessment Questionnaire
3. Other supporting documents:
         - Veterans Preference Documentation, if applicable 
         - College transcript(s), if qualifying based on education
         - SF-50, Notification of Personnel Action (if applying as a status candidate with current or 
           former Federal service)


Contact Information:
Philadelphia Services Branch
Phone: (215)861-3074
Email: philadelphia@opm.gov
Or write:
Philadelphia Services Branch
US Office of Personnel Management
600 Arch Street
Philadelphia, PA 19106
USA
What To Expect Next:

Once the online questionnaire is received you will receive an acknowledgement email that your submission was successful. Based upon your score, you may be referred to the hiring official. If your name is referred to the hiring official, you may be contacted directly by that office for a possible interview. 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)


EEO Policy Statement:   http://www.usajobs.gov/eeo
Reasonable Accommodation Policy Statement:   http://www.usajobs.gov/raps
Veterans Information:   http://www.usajobs.gov/vi
Legal and Regulatory Guidance:   http://www.usajobs.gov/lrg
USAJOBS Control Number: 1753355

Control Number: 84998822

 

Note: We cannot accept applications on behalf of Federal Agencies. Application instructions are listed within the Job Description.

 

 

 

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