Consumer Safety Officer (Drug and Pharmacy Compounding)
50% or less - You may be expected to travel for this position.
Relocation expenses reimbursed No
BASIC QUALIFICATIONS REQUIREMENT: This position requires a degree or completion of specific courses in order to meet the basic education requirement. You must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned. Your transcript(s) must clearly demonstrate the course(s) listed in the Basic 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. Degree requirements must be met by the closing date of this job announcement and your transcript(s) submitted must reflect this. If you are selected for the position, an official transcript sent directly from your educational institution will be required for verification prior to appointment.
Applicants must have successfully completed one of the following (A or B):
A. Bachelor's or graduate/higher level degree in quality assurance or a related degree that included at least 30 semester hours in one or a combination of the following: consumer laws, biological sciences, food science, chemistry, pharmacy, physical sciences, food technology, nutrition, medical science, engineering, epidemiology, veterinary medical science, legal investigations, law enforcement, or related scientific fields that provided knowledge directly related to consumer safety officer work. The 30 semester hours may 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. Combination of education and experience--courses consisting of at least 30 semester hours in the fields of study described in paragraph A above, plus appropriate experience or additional education.
TIME-IN-GRADE REQUIREMENT: Applicants must have 52 weeks at the GS-13 or higher.
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 and that is typically in or related to the work of the position to be filled, and can be demonstrated thorough knowledge of science, laws and regulations of the Agency. Specialized experience includes performing analysis and evaluation on data samples, assessing evidence and determining the nature of the violation and initiating regulatory action; interpreting and implementing existing laws, regulations, and guidance; and planning, organizing, prioritizing technical, investigative and professional work; conducting highly technical, complex and multi-faceted inspections and in-depth investigations in the area of pharmaceutical products, drug and pharmacy compounding; and developing, organizing and managing pharmaceutical field and headquarter assignments.
GS-14: One year of specialized experience at least equivalent to the GS-13 in the Federal Service.
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.
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 more information about this requirement, please visit the U.S. Department of Education website for Foreign Education Evaluation.
ADDITIONAL CONDITIONS OF EMPLOYMENT:
- Pre-employment physical required: No
- Drug testing required: No
- License required: No
- Mobility agreement required: No
- Immunization required: No
- Bargaining Unit Position: Yes, NTEU
- If you are serving, or have served in the last 5 years (from 05/30/2018) as an Executive Branch political, Schedule C, or Non-career SES appointee, HHS/FDA may be required to obtain approval by the Office of Personnel Management (OPM) prior to beginning employment. You can find out if you have held one of these appointment types by looking at your Standard Form 50s in your Electronic Official Personnel Folder (eOPF), in Section 5 where the legal authorities are listed. If you have served or are currently serving, you must provide a copy of your SF-50, Notification of Personnel Action, documenting this appointment. In addition, you will be required to respond to the question in the assessment and certify your responses to the questionnaire. Political Appointees FAQ - OPM
- Financial disclosure statement, OGE-450, required: This position will be subject to FDA's prohibited financial interest regulation. If you are hired, you may be required to divest of certain financial interests. You are advised to seek additional information on this requirement from the hiring official before accepting any job offers.
You will be evaluated for this job based on how well you meet the qualifications above.
Once the job opportunity announcement closes (at 11:59 pm ET on 05/30/2018), a review of your resume and supporting documentation will be conducted, the information will be compared against your responses to the assessment questionnaire to determine your eligibility for this internal position. Eligible internal candidates will be referred to the hiring official for consideration.
Please follow all instructions carefully. Errors or omissions may affect your eligibility.
Basis of Rating: Merit Promotion Procedures for the Food and Drug Administration (FDA) 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 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 Competencies/KSA's.
- Program Knowledge
- Technical Competence
- Oral Communication
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