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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
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