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

Department:Department Of Health And Human Services

Agency:Food and Drug Administration

Job Announcement Number:HHS-FDA-ORA-DE-13-916300

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

The contents of the announcement can still be viewed.

SALARY RANGE:

$71,674.00 to $93,175.00 / Per Year

OPEN PERIOD:

Friday, July 05, 2013 to Friday, July 19, 2013

SERIES & GRADE:

GS-0696-13

POSITION INFORMATION:

Full Time - Permanent

PROMOTION POTENTIAL:

13

DUTY LOCATIONS:

Many vacancies in the following location:
Location Negotiable After Selection, United States

WHO MAY APPLY:

United States Citizens

SUPERVISORY STATUS:

No

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 Global Regulatory Operations and Policy (OGROP), Office of Regulatory Affairs (ORA).

 

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.


This vacancy is also being announced concurrently with vacancy announcement HHS-FDA-ORA-MP-13-916754 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.

 

Salary Range indicated above reflects only the General Salary (GS) base rate table.  Assigned Duty location will determine the proper GS locality table once Duty Station is assigned.



Who May Apply:  Open to all United States Citizens.

This announcement may be used to fill additional vacancies.

RELOCATION AUTHORIZED

  • No

KEY REQUIREMENTS

  • U.S. Citizenship is required.
  • Background investigation required.
  • One year probationary period may be required.
  • Travel required both International and Domestic more than 50% of the time.
  • Transcripts required.
  • A Valid driver's license is required.

DUTIES:

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This position is located in an FDA District Office or Resident Post, and represents the highest level of expertise in a district for the inspection of firms engaged in the manufacture, processing, and control of human or veterinary pharmaceutical products, for compliance with FDA laws and regulations. Assignments will involve inspections/investigations across District lines. As a Program Manager, is a primary source of expertise in an assigned geographical area who resolves the most difficult, controversial and complex inspectional problems which involve a combination of scientific and regulatory responsibilities. Major duties includes:

·         Serves as a principal source of expertise within a geographical area provides extensive advisory, liaison and consultative services for drug programs to regulated industries, State agencies, other Federal agencies and Agency management.

·         Advises on new advances in technology related to drug products, new programs, laws and regulations, significant court decisions, and any new trends or scientific findings involving drug products.

·         Meets with hostile or uncooperative industry representatives to exchange information and to provide advice and guidance regarding those aspects of the application, notice, amendment, supplement or report which fall within area of review with emphasis on deficiencies.  Interactions require considerable tact and firmness to obtain needed information regarding submissions.

·         Develops, monitors, coordinates, and implements FDA Agency policy and initiatives in relation to human or veterinary pharmaceutical products ensuring compliance with FDA laws and regulations.

·         Conduct quality assurance inspections of domestic and international manufacturing processes and write establishment inspection reports and recommendations for classificatons.

·         Plan, conduct and direct highly technical, complex inspections related to production, control, testing and processing human or veterinary pharmaceutical products.

·         Perform investigations involving complaints or injury/death.

·         Conduct complex and in-depth investigations, determine required course of action and level of investigative efforts required.

·         Document inspection findings in prescribed written format according to FDA policies and guidelines.

·         Maintain a working knowledge and awareness of the Current Good Manufacturing Practices objectives and exercise analytical judgment to anticipate potential problems.

 


QUALIFICATIONS REQUIRED:

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Basic Requirements: 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-

 

Combination of education and experience.--courses consist of at least 30 semester hours in the fields of study described in A above, plus appropriate experience or additional education (MUST SUBMIT TRANSCRIPTS). In addition to meeting the educational requirements, candidates must possess one year of specialized experience at the next lower grade:  

 

In addition to meeting the educational requirements, candidates must possess one year of specialized experience at the next lower grade:

 

GS-13:  Applicant must have one year of specialized experience equivalent to GS-12 in serving as technical expert in analyzing behavior and impact on the safety and effectiveness of manufactured pharmaceutical products;provide advisory and consultative services for drug programs to regulate industry, state and federal agencies;  Plans, conducts and direct technical inspections related to the production,  and process of human and veterinary pharmaceutical products.

 

You must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned.  Degree requirements must be met within 30 days of the closing date of this job announcement and your transcript(s) submitted must reflect this.

 

This position requires that specific course(s) be demonstrated to meet the basic education requirement.  Your transcript(s) must clearly demonstrate the course(s) listed in the qualification requirement section.  If the transcript(s) does not clearly demonstrate this you must submit a copy of the course description and/or other documentation demonstrating that the courses are equivalent.

 

Failure to provide any of the above will result in ineligible rating.

 

All requirements must be met by the closing date of this 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.

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 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) 796-8435 prior to accepting such a position.

  

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

 

7. Bargaining Unit Position: Yes

 

8. Drug Screening Required: No

 

9. Recruitment incentives may be authorized: No

 

10. Student loan repayment incentive authorized: No 

 

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

 

12. Travel required both International and Domestic more than 50% of the time.

HOW YOU WILL BE EVALUATED:

Once the job opportunity announcement closes, a review of your résumé 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 résumé and supporting documentation, a determination is made that you have inflated your responses when compared to your background information, your score may be adjusted to more accurately reflect your skills and abilities.  Please follow all instructions carefully. Errors or omissions may affect your eligibility.

Basis of Rating:

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 assigned to one of the following quality categories:  Best Qualified, Well Qualified or Qualified.

 

Best Qualified – Applicants who have experience that is almost identical to those required by the position, including any quality ranking factors identified.

Well Qualified – Applicants who have experience that is very similar to those required by the position.

Qualified – Applicants who meet minimum qualification requirements, but do not identify any additional qualifying experience or skill.

The Category Rating Process does not add veterans’ preference points but protects the rights of veterans by placing them ahead of non-preference eligible within each category.  Preference eligible 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).  You do not have to respond to the KSA’s separately, but your resume should contain sufficient information to demonstrate possession of the KSA’s. 

 

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

 

Required Knowledge, Skills, and Abilities (KSAs):

 

  • Knowledge of Current Good Manufacturing Practices (GMP) related to the manufacture of pharmaceuticals (human or veterinary).
  • Ability to conduct Inspections/Investigations.
  • Skill in Oral Communication.
  • Skill in Written Communications. 


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

 

Career Transition Program:  This program applies to Federal workers whose positions have been deemed “surplus” or no longer needed, or an employee who has been involuntarily separated from a Federal service position within the competitive service.  To receive selection priority for this position, you must be rated “well-qualified”.  Well-qualified means eligible applicants whose knowledge, skills, and abilities clearly exceed the minimum qualification requirements of the position.  For information on how to apply and what documents to submit as an ICTAP eligible, see: http://www.opm.gov/rif/employee_guides/career_transition.asp



HOW TO APPLY:

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To apply for this position, you must complete the occupational questionnaire and submit the documentation specified in the Required Documents section below.

The complete application package must be submitted by 11:59 PM (EST) on Friday, July 19, 2013 to receive consideration.

  • To begin, click Apply Online to create a USAJOBS account or log in to your existing account. Follow the prompts to select your USAJOBS resume and/or other supporting documents and complete the occupational questionnaire.
  • Click the Submit My Answers button to submit your application package.
  • It is your responsibility to ensure your responses and appropriate documentation are submitted prior to the closing date. 
  • To verify your application is complete, log into your USAJOBS account, https://my.usajobs.gov/Account/Login, select the Application Status link and then select the more information link for this position. The Details page will display the status of your application, the documentation received and processed, and any correspondence the agency has sent related to this application.  Your uploaded documents may take several hours to clear the virus scan process.
  • To return to an incomplete application, log into your USAJOBS account and click Update Application in the vacancy announcement.  You must re-select your resume and/or other documents from your USAJOBS account or your application will be incomplete.
  • 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.

 



REQUIRED DOCUMENTS:

All applicants are required to submit the following supporting document type(s):
   ·Resume
   ·Transcript

Applicants may also submit the following supporting document type(s),which may not be required for all applicants:
   ·DD-214
   ·SF-15
   ·SF-50

 

Other Supporting Documents:  (only submit if applicable)

·        College transcripts (unofficial copy acceptable)

·        Veterans’ Preference documentation (e.g., DD-214 which shows type of discharge/character of service, SF-15, VA letter, etc.)

CTAP/ICTAP documentation

Faxing Applications or Supporting Documents:

You are encouraged to apply online.  Applying online will allow you to review and track the status of your application.

NOTE:  If you applied online and your application is complete, do not fax the paper application (1203FX) as this will overwrite your prior online responses and may result in you being found ineligible.

If you completed the occupational questionnaire online and are unable to upload supporting document(s):

1. To fax your documents, you must use the following cover page http://staffing.opm.gov/pdf/usascover.pdf and provide the required information.  The Vacancy ID is 916300.

2. Fax your documents to 1-478-757-3144.

If you cannot complete the Application Package online, you may fax all of your materials.  The complete application package must be submitted by 11:59 PM (EST) on Friday, July 19, 2013  to receive consideration.  Keep a copy of your fax confirmation in the event verification is needed.

To complete the occupational questionnaire and submit via fax:

1. Click the following link to view and print the occupational questionnaire View Occupational Questionnaire.

2. Print the 1203FX form, follow the instructions and provide your responses to the occupational questionnaire items http://www.opm.gov/forms/pdfimage/opm1203fx.pdf

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@psc.gov.  The decision on granting reasonable accommodation will be made on a case-by-case basis.

For Résumé and Application Tips visit: https://help.usajobs.gov/index.php/Tips.

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. Once this process is completed, you will be notified of your status via e-mail.

 


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Job Announcement Number:

HHS-FDA-ORA-DE-13-916300

Control Number:

346390600