This position is located in the Office of Regulatory Affairs (ORA), Office of Enforcement and Import Operations (OEIO), Food and Drug Administration (FDA). The incumbent will assist the immediate supervisor or a team leader by planning inspections, investigations, sample collections, and related activities in the area of assigned responsibility.

Duties

Assesses the degree of consistency with Good Manufacturing Practices and efficacy of quality controls. Collects samples and conducts field analyses involving environmental sampling and assessment, review for compliance with good manufacturing practices, records review, etc. Prepares written report showing results of inspections and investigations. Documents and organizes required evidence, data, and other information to support violations noted during inspections, investigations, sample collections or filer audits. Plans and conducts regulatory inspections and in-depth investigations of various industry establishments; such as manufacturers, repackers, own label distributors, and importers. Prepares final reports, position papers and other written documentation that support investigative findings and recommendations.

Requirements

• Citizenship Requirement: You must be a U.S. Citizen to be considered for this advertisement unless explicitly stated otherwise.
• Selective Service Registration: All applicants born male, on (or after) 12/31/1959, must be registered with the Selective Service System OR have an approved exemption. Visit www.SSS.gov for more info.
• FDA participates in e-Verify: All new hires must complete the I-9 form; this information will be processed through e-Verify to determine your employment eligibility. If a discrepancy arises, you must take affirmative steps to resolve the matter.
• Background Investigation Requirement: All employees must pass a security investigation. Failing to pass the background check may be grounds for removal or legal action. If hired, you may be subject to additional investigations at a later time.
• You must meet ALL requirements by the closing date of this announcement to be considered. Only education, experience, and qualifications attained by this date will be considered. You must continue to meet all requirements through the hiring process.
• Certification of Accuracy: All information concerning eligibility and qualification is subject to investigation and verification. False representation may be grounds for non-consideration, non-selection, or appropriate legal action.
• Direct Deposit: You will be required to have all federal salary payments electronically deposited into a bank account with a financial institution of your choice.
• Additional selections may be made from this vacancy, within the same geographical area, by other organizational elements from within FDA, through shared corporate recruiting activities.

Qualifications

The position of Consumer Safety Officer falls under the 0696 occupational series. To qualify for this position at grade GS-7/9, you must meet all requirements by 11:59 pm EST on 04/09/2024. Basic Requirements: 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. Minimum Qualifications: Specialized experience is experience that 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. The specialized experience must demonstrate one year of full-time work experience, or the equivalent if part-time (for example, an employee working 20 hours per week for a 12-month period should be credited with 6 months of experience.) Experience may have been obtained in either the federal service or its equivalent with state or local government, the private sector, or nongovernmental organizations. GS-07: You must have 1 year of specialized experience equivalent to at least the GS-05, in the Federal service, which includes: assisting in conducting routine inspections or investigations and/or sample collection and analysis to ensure compliance with manufacturing practices. -OR- B. One year of graduate level education in related to the position being filled from an accredited college and/or university. One year of full-time graduate education is considered to be the number of credit hours that the school attended has determined to represent one year of full-time study. If that number cannot be obtained from the school, 18 semester hours will satisfy an academic year of graduate study. -OR- C. A bachelor's degree as described in the Individual Occupational Requirement above AND meet Superior Academic Achievement provision (S.A.A.) criteria (visit the site for more detail information). S.A.A. is based on (1) class standing, (2) grade-point average, or (3) honor society membership. -OR- D. Have a combination of experience as described in "A" above and education as described in "B" above. When combining education with experience, first determine the applicant's total qualifying education as a percentage of the education required for the grade level; then determine the applicant's experience as a percentage of the experience required for the grade level; finally, add the two percentages. The total percentage must equal at least 100 percent to qualify. GS-09: You must have 1 year of specialized experience equivalent to at least the GS-07, in the Federal service, which includes: gathering and performing standard analyses of scientific data; reviewing and evaluating scientific data for efficacy and safety; preparing reports on scientific/technical study findings. -OR- B. A master's or equivalent graduate degree or two full years of progressively higher level graduate education leading to such a degree in a field related to the position to be filled. -OR- C. A combination of specialized experience and graduate level education in a field related to the duties of this position that meets 100% of the qualification requirements for this position. When combining education with experience, first determine the applicant's total qualifying education as a percentage of the education required for the grade level; then determine the applicant's experience as a percentage of the experience required for the grade level; finally, add the two percentages. The total percentage must equal at least 100 percent to qualify. Please note that you must submit the unofficial transcript to support your claim. NOTE: It is your responsibility to ensure your responses and appropriate documentation is submitted prior to the closing date. To verify your application is complete, log into your USAJOBS account, https://secure.login.gov/, 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. Be sure that any uploaded documents you provide in your application are free of document security or compression which might render the document unreadable by our system. IN DESCRIBING YOUR EXPERIENCE, PLEASE BE CLEAR AND SPECIFIC. WE WILL NOT MAKE ASSUMPTIONS REGARDING YOUR EXPERIENCE. Qualifications are based on breadth/level of experience. In addition to describing duties performed, applicants must provide the exact dates of each period of employment (from MM/YY to MM/YY) and the number of hours worked per week if part time. As qualification determinations cannot be made when resumes do not include the required information, failure to provide this information may result in disqualification. Applicants are encouraged to use the USAJOBS Resume Builder to develop their federal resume. Experience refers to paid and unpaid experience, including volunteer work done through National Service programs (e.g., Peace Corps, AmeriCorps) and other organizations (e.g., professional; philanthropic; religious; spiritual; community, student, social). Volunteer work helps build critical competencies, knowledge, and skills and can provide valuable training and experience that translates directly to paid employment. You will receive credit for all qualifying experience, including volunteer experience.

Education

TRANSCRIPTS:
Positions which are scientific or technical in nature often have very specific educational requirements. You must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned. If you are using education completed in foreign colleges or universities, see the Foreign Education section below for additional requirements.

Pay careful attention to the Qualifications and Education sections to identify vacancies where a transcript is required. Even if you hold a similar position or are a current employee, you are not exempt from transcript requirements.


Electronic Transcript Caution: If you have obtained your transcripts electronically, the file might contain security measures that could prevent our application system from reading the file. Therefore, you should consider asking the institution to provide the file in a non-secured electronic format. Alternatively, you could scan or take a photo of the printed copy of the transcript. If your uploaded transcript cannot be read by our system, you may receive consideration and credit for the information we can access.

See the Application Manager Documentation for tips on submitting your paper-based documents.


FOREIGN EDUCATION
Applicants using part, or all of their education completed outside of the U.S. to meet the qualification requirements, must have their foreign education evaluated by an accredited organization to ensure that the foreign education is comparable to education received in accredited educational institutions in the U.S. We will only accept the completed foreign credential evaluation.

To be acceptable, the foreign credential evaluation must include/describe at a minimum, the following information: (1) The type of education received by the applicant; (2) The level of education in relation to the U.S. education system, and state that its comparability recommendations follow the general guidelines of the International Evaluation Standards Council; (3) The content of the applicant's educational program earned abroad, and the standard obtained; (4) The status of the awarding foreign school's recognition and legitimacy in its home country's education system; and (5) Any other information of interest such as what the evaluation service did to obtain this information, the qualifications of the evaluator, and any indications as to other problems such as forgery. Note: Some positions require the completion of specific courses or a specified number of credit hours. Therefore, the foreign credential evaluation should provide information similar to that of an official transcript, to include a list of the courses taken, quarter and/or semester hours awarded, the cumulative grade point average (GPA), honors received, if any, date degree awarded.
Applicants can request an evaluation from a member organization of one of the two national associations of credential evaluation services listed below:

1. National Association of Credential Evaluation Services (NACES)
2. Association of International Credentials Evaluators (AICE)

Credential evaluations are not free, and applicants are responsible for the cost of the selected service.
For more information about this requirement, please visit the : https://sites.ed.gov/international/recognition-of-foreign-qualifications/

Contacts

• Address FDA Office of Regulatory Affairs 10903 New Hampshire Ave Silver Spring, MD 20993 US
• Name: FDA Applicant Help Desk
• Phone: 866-807-3742
• Email: [email protected]