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 (Biologics/Blood Bank/Tissue), GS-0696-13

Department:Department Of Health And Human Services

Agency:Food and Drug Administration

Job Announcement Number:HHS-FDA-ORA-MP-13-864191

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 $119,926.00 / Per Year

OPEN PERIOD:

Thursday, April 04, 2013 to Wednesday, April 24, 2013

SERIES & GRADE:

GS-0696-13

POSITION INFORMATION:

Full Time - Permanent

PROMOTION POTENTIAL:

13

DUTY LOCATIONS:

1 vacancy in the following location(s):
Dallas, TX United StatesView Map
San Antonio, TX United StatesView Map
Houston, TX United StatesView Map

WHO MAY APPLY:

Current Career/Career Conditional status employees with the Food and Drug Administration, Office of Regulatory Affairs.

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:  This vacancy is open to current Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA) employees with competitive status only.  Competitive status refers to employees who are serving on a career or career conditional appointment.

 

Current FDA/ORA PHS Commissioned Corps 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.

 

YOU MUST SUBMIT YOUR SF-50.

 

This position is located in the Food and Drug Administration, Office of Regulatory Affairs, Southwest Region, Dallas District Office, Investigations Branch.   This position will be filled in either  Dallas, Texas, Houston, Texas or San Antonio, Texas.

 

Type of appointment:   This is a permanent full time, Career/Career Conditional appointment.

 

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

 

KEY REQUIREMENTS

  • U.S. Citizenship is required.
  • Applicant must have a valid drivers license.
  • 50% travel is required including international travel.
  • Moving expenses may be authorized pending availability of funds.

DUTIES:

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Major Duties:
This position represents the highest level of expertise in a district office in areas which the inspection of licensed and unlicensed blood banks, manufacturers of source plasma and all processes utilizing phersis procedures, as well as human tissue and cellular tissue products.  The incumbent is considered the primary expert who resolves the most difficult, controversial and complex inspectional problems involving scientific and regulatory biologic responsibilities in an area of expertise.   Duties and responsibilities include:

·    Plan, conduct and direct highly technical, complex and multi-faceted inspections and in-depth investigations in the area of blood banks and plasamapheresis programs, and human tissue and tissue based products.  

·    Make recommendations to regional and district management officials as to whether or not a firm/individual involved in the production, control and testing of blood  bank, plasmapheresis or other biological product establishment, including human tissue and tissue based products is in compliance with Current Good Manufacturing Practices (CGMP) issues 

·    Review reports of inspections and investigations for violations within the area of expertise including emergency situations, uncooperative industry officials, ambiguous or dubious evidence and lack of precedents and guidelines

·    Advise on new advances in technology related to biological products,  including blood banks, plasmapheresis, human tissue, and tissue based products, new programs, laws and regulations, significant court decisions, and any new trends or scientific findings involving biologic programs.

·    Serve on task forces and study groups charged with considering problems or directions in the area of biologic.

·    Serve as an expert witness in area of expertise in court cases dealing with biologic relating to assigned area of expertise.


QUALIFICATIONS REQUIRED:

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Qualifications: 

Basic Requirements:

The basic educational requirements of the Qualification Standards for the Professional and Scientific Positions under the GS-696 series must be met.  The requirements are as follows:

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.


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:

 

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 thorough knowledge of enabling legislation, policies, implementing regulations and procedures; skill in selecting, adapting, and applying investigative methods and negotiating techniques; knowledge of a variety of various scientific and technical disciplines necessary to carry out task.

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

 

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. 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.

 

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. Moving expenses may be authorized pending the availability of funds.

 

5. Bargaining Unit Position: Yes

 

6. Drug Screening Required: NO

 

7. Recruitment Bonus may be authorized: NO

 

8. Research position: NO

 

9. Supervisory position: NO

 

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

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. Merit Promotion Procedures for the Food and Drug Administration (FDA) 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 two categories:  Best Qualified or Qualified.

 

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

  1.  Knowledge of pertinent laws, regulations, policies, precedent, programs goals and objectives.
  2. Ability to apply laws, guidance, consultation and interpretation of policies.
  3. Ability to plan, organize, lead and oversee major initiatives, progress and programmatic results.
  4. Skill in selecting, adapting and applying investigative methods and negotiating techniques.
  5. Skill in interpreting laws, policies and their application to the broad field of pharmaceuticals.
  6. Ability to communicate orally.
  7. 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).

 



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 864191.  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 Center HelpDesk Telephone (888)-478-4340; TTY/TDD: (866)-539-4484; 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.      - 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, April 24, 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-ORA-MP-13-864191

Control Number:

340403200