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 (BIO-RESEARCH MONITORING), GS-0696-13

Department:Department Of Health And Human Services

Agency:Food and Drug Administration

Job Announcement Number:HHS-FDA-ORA-MP-13-905157

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

The contents of the announcement can still be viewed.

SALARY RANGE:

$81,823.00 to $119,935.00 / Per Year

OPEN PERIOD:

Monday, June 10, 2013 to Wednesday, July 10, 2013

SERIES & GRADE:

GS-0696-13

POSITION INFORMATION:

Full Time - Permanent

PROMOTION POTENTIAL:

13

DUTY LOCATIONS:

1 vacancy in the following location(s):
Syracuse, NY United StatesView Map
Buffalo, NY United StatesView Map
Queens, NY United StatesView Map
Binghamton, NY United StatesView Map
Rochester, NY United StatesView Map
More Locations  (4)

WHO MAY APPLY:

AGENCY EMPLOYEES: FDA WIDE

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.

WHO MAY APPLY:  FDA-Nationwide.  This vacancy is open nationwide to current permanent (career/career-conditional appointments) employees of the Food and Drug Administration (FDA) only.  Current FDA employees serving under a Schedule A appointment are eligible for consideration. Title 42 employees not eligible for reinstatement will not be considered.
 
YOU MUST SUBMIT YOUR SF-50.

FDA Commissioned Officers interested in performing the duties of this position within the Commissioned Corps may apply online to this announcement.  Candidates will be referred to (CC) personnel and not as candidates for conversion to a permanent career or career-conditional appointment.

LOCATION:
 This position is located in the Food and Drug Administration, Office of Regulatory Affairs, Northeast Region, New York District.  The position may be filled in any of the locations listed below.  Location and salary will be determined upon selection. 

Jamaica, NY

Central Islip, NY

White Plains, NY

Albany, NY

New Windsor, NY

Binghamton, NY

Syracuse, NY

Rochester, NY

Buffalo, NY

  
TYPE OF POSITION:  This position is being filled on a full-time, permanent basis.

PROMOTION POTENTIAL:  GS-13 is the full performance level.  

Salary range listed includes locality pay.

KEY REQUIREMENTS

  • U.S. Citizenship required.
  • Please carefully read and follow the HOW TO APPLY instructions.
  • Must meet time-in-grade requirement within 30 days of the closing date.
  • Must possess a valid driver's license.
  • 50% travel may be required.

DUTIES:

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Incumbent represents the highest level of expertise for inspections involved in FDA's bioresearch monitoring program including inspections of clinical investigators, sponsor/monitors, IRB's and GLP establishments for compliance with FDA laws and regulations.  The incumbent is a primary source of expertise who resolves the most difficult and complex inspectional problems which involve a combination of scientific and regulatory responsibilities.  Specific duties include:

 

·         Plan, conduct and direct highly technical, complex and multi-faceted inspections and in-depth investigations.

·         Make recommendations to regional and district management official as to whether or not a firm involved in the pre-market testing of products is in compliance with Current Good Manufacturing Practices (CGMP) and Current Good tissues Practices (CGTP).

·         Review reports of inspections and investigations for violations and determine the sufficiency of the evidence.

·         Provide extensive advisory, liaison and consultative services for biologic programs to regulated industries, State agencies, other Federal agencies and Agency management.

·         Meet with (some time hostile or incorporative) industry representatives to exchange information and to provide advice and guidance regarding applications, notices, amendments, supplements or reports which fall within area of review and deficiency.

·         Manage the review of previous approved products to determines whether continue to meet the current criteria.

·         Conduct inspections and investigations of facilities where only limited guidance is available and proposed or new regulations is used to evaluate industry or, the investigation my results in considerable attention and review in the media, Congress or, other forces inside or outside the agency.

·         Develop and implement formal training programs for agency personnel, industry, state and local officials and, provide technical expertise to industry.

·         Conduct on the job training and serve as principal advisor and expert.

·         Provide assistance on planning, coordinations and evaluating the bioresearch program.

 


QUALIFICATIONS REQUIRED:

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In addition to meeting the educational requirements, candidates must possess one year of specialized experience at the next lower grade and meet the time-in-grade requirement:

GS-13: 52 weeks of specialized experience at least equivalent to the GS-12 level.

 

SPECIALIZED EXPERIENCE:  Experience directly related to the position to be filled which has equipped the applicant with the particular knowledge, skills and abilities to perform successfully the duties of the position.  Examples of specialized experience includes knowledge of FDA regulations, laws, practices and procedures and knowledge of scientific principles and theories and inspections/investigations techniques and practices.

TIME-IN-GRADE REQUIREMENT: (Must be met within 30 days of the announcement closing date)

GS-13: Applicants must have 52 weeks at the GS-12 or higher.

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.


EDUCATION STATEMENT - Individual Occupational Requirement:
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.

If you have Federal status and have never been on an appointment in this occupational series, you must submit your transcripts as indicated above.  If you have Federal status and are currently or were previously on an appointment in this occupational series, you do not need to submit transcripts at the time of application. Instead, you should submit an SF-50 showing that you were on an appointment in this occupational series.

EDUCATION REQUIREMENT:  Applicants must have successfully completed one of the following (A or B):

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 described 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/ .

CONDITIONS OF EMPLOYMENT:  

1.  Additional Security and Background Requirements:  May be referred depending on the position being filled.  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.  All qualification requirements must be met by the closing date of the announcement. 

3.  Financial disclosure statement may be required. 

4.  Relocation expenses may be paid: Yes 

5.  Bargaining Unit Position: Yes 

6.  Drug Screening Required: No 

7.  Recruitment Bonus may be authorized: No 

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

9.  Certain positions within the FDA are subject to strict restrictions on financial holdings (FDA regulated financial holdings).  To determine whether this position is affected, applicants are advised to seek additional information during the interview process from the Ethics and Integrity Staff, Office of Management Programs, Office of Management at (301)827-5511 prior to accepting such a position.

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.
 

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

1.  Knowledge of pertinent laws, regulations policies, precedents and work process and programs.

2.  Ability to plan, organize, lead and oversee major initiatives, progress and programmatic results.

3.  Ability to apply laws, guidance, consultation and interpretation of policies.

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

5.  Ability to communicate orally.

6.  Skill in written communication.

 

 


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:

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

Career Transition Assistance Program (CTAP):  For information on how to apply as a CTAP eligible see http://opm.gov/rif/employee_guides/career_transition.asp#ctap.  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 905157.  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. 

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 Telephone (888)-478-4340; TTY/TDD: (866)-539-4484; or by email quickquestions@psc.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

        - 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: http://www.usajobs.gov/ResourceCenter/Index/Interactive/ResumeAndApplicationTips#icc.

 

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

Additional Duty Location Info

1 vacancy in the following locations:
Syracuse, NY United StatesView Map
Buffalo, NY United StatesView Map
Queens, NY United StatesView Map
Binghamton, NY United StatesView Map
Rochester, NY United StatesView Map
White Plains, NY United StatesView Map
Islip, NY United StatesView Map
Albany, NY United StatesView Map
New Windsor, NY United StatesView Map

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Job Announcement Number:

HHS-FDA-ORA-MP-13-905157

Control Number:

345157700