Consumer Safety Officer (Planning)

Summary

This position is located in the Office of Inspections and Investigations (OII), Office of Human and Animal Drug Inspectorate (OHADI), Division of Human and Animal Drug Foreign Inspectorate (DHADFI), Human and Animal Drug Foreign Operations Branch (HADFOB). The incumbent serves as a Consumer Safety Officer and is responsible for assisting in planning, establishing, directing, and implementing the International Inspection Programs.

Duties

• Serves as the headquarters authority on drug inspection techniques. Provides a focal point within FDA to whom the headquarters and field service may turn for authoritative guidance and consultation regarding inspection and investigation methods and procedures necessary to accomplish compliance objectives. Selects appropriate methods for inclusion in nationwide investigative processes and procedures. Ensures that descriptive material communicate in sufficient detail to satisfy the needs of the operating investigators. Receives and resolves inquiries in this regard. Conducts research to develop improved inspectional techniques requisites for coping with advances in manufacturing technology and bulk distribution practices. In making these studies, explores backgrounds, conditions, and goals with program officials and subject matter specialist in the Centers and in the field. Reviews and determines the usefulness of employee suggestions emanating from FDA field employees. Endorses with recommendations for acceptance in whole or in part, or furnishes reasons outlining basis for rejection. Assists the Branch Chief in performing the following: Appraises and evaluates the overall effectiveness of the international inspection programs and develops new concepts as needed; maintains, coordination with appropriate FDA units such as the Office of the Commissioner, Associate Commissioner for Inspections and Investigations, Assistant Commissioner for Partnerships and Policy, and the medical products center. Assures that the administrative elements of the program are met, such as obtaining of passports and visas; obtaining technical assistance for the field and headquarters units; contact with other federal, health and consumer protection agencies, such as the National Institutes of Health; contacts with foreign embassies and ministries of health, and a variety of other offices. Selects appropriately qualified investigators to conduct inspections and provide technical support. Provides oversight, evaluation and coordinates foreign inspection work for the operating investigators while they are actively participating in the program conducting international inspections. This includes review and appropriate forwarding of inspectional reports. Performs at least one foreign inspection trip annually assigned by division management. Performs other duties as assigned.

Qualifications

The position of Consumer Safety Officer (Planning) falls within the 0696 occupational series. To qualify for this position at grade GS-13, you must meet Time-in-Grade requirements by 11:59 pm EST on 11/09/2026. Basic Requirements for Consumer Safety Series 0696: Applicants must meet one of the following requirements. 1. 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 2. 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-13: You must have 1 year of specialized experience equivalent to at least the GS-12, in the Federal service, which includes: researching firm histories and conducting pre-inspection preparation using OSAR, eDRLS, CMS, and other relevant FDA/OII databases to support risk-based inspection planning; independently conducting foreign and domestic pharmaceutical inspections in accordance with FDA drug compliance programs; managing multiple concurrent assignments, organizing competing priorities, and completing tasks thoroughly and on time; and coordinating across teams through oral and written communication to support the planning and execution of foreign drug inspections. 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. 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. NOTE: It is your responsibility to ensure your responses and appropriate documentation is submitted prior to the closing…

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. 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…