In addition to meeting the educational requirements, candidates must possess one year of specialized experience at the next lower grade:
GS-13: 52 weeks of specialized experience at least equivalent to the GS-12 level.
SPECIALIZED EXPERIENCE: 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.
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.
TIME-IN-GRADE REQUIREMENT: In addition to the specialized experience requirement, applicants must meet the following time-in-grade requirement within 30 days of the closing date of this announcement.
GS-13: Applicants must have 52 weeks at the GS-12 or higher.
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.
Degree requirements must be met within 30 days of the closing date of this job announcement and your transcript(s) submitted must reflect this.
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.
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.
Failure to provide any of the above will result in ineligible rating.
To qualify, applicants must have successfully completed one of the following:
For Consumer Safety Officer, GS-0696:
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 in "A" 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. 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. One-year probationary period may be required.
7. Travel, transportation, and relocation expenses will be paid: No
8. Bargaining Unit Position: Yes
9. Drug Screening Required: No
10. Time in grade (TIG) must be met within 30 days of the closing date of the announcement.
11. Travel required both International and Domestic more than 50% of the time.
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):
- 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.