Summary This position is being filled under a stream-lined hiring authority, Title 21 of the United States Code (21 US Code 379d-3a) as amended by the 21st Century Cures Act of 2016, section 3072 and the Consolidated Appropriations Act of 2023, Section 3624. The candidate selected for this position will serve under a career or career-conditional appointment and be paid under the provisions of this authority. This position is being recruited based on the Title 21 Pay Table 1, Band W (GS-07 equivalent). Responsibilities As Associate Investigator, the incumbent has demonstrated and is recognized for a high level of competence in the full range of commodities regulated within the boundaries of an FDA Program such as foods, drugs, medical devices, imports, etc., or in a narrow specialty within a program area. Assignments involve a combination of scientific and regulatory responsibilities which usually call for a number of atypical inspections, or intensive investigative approaches to be applied to a wide variety of regulatory functions or scientific evaluations; and include the difficult and complex sample collections, establishment inspections, unusual or novel special investigations. Inspections and Investigations: Receives fundamental training, through classroom and on-the-job instruction, to provide a more thorough understanding of and exposure to FDA laws and regulations, administrative policies, manufacturing processes, good manufacturing practices, and the various methods employed in the conduct of establishment inspections, sample collections and investigations. The investigator independently conducts inspections, investigations, and sampling at lower complexity human food facilities to ensure compliance with FDA laws, policies, and regulation of human commodities in which the employee has received specific or related training. Collects samples and conducts field analyses involving environmental sampling and assessment, review for compliance with good manufacturing practices, records review, etc. Incumbent interacts with and advises various levels of officials representing the establishments subject to regulatory review. The incumbent initiates contact with industry officials to obtain information on regulatory and scientific documents and to discuss the status of investigations. Developmental assignments include assisting higher level employees in inspections or other field activities, meetings, and conference calls with regulated industry. Such assignments with senior Investigators involve complex manufacturing practices, a broad variety of raw materials, advanced instrumentation and complex assembly line operations, diverse manufactured products, and complicated paperwork each of which requires separate manufacturing and inspectional techniques. Incumbent conducts re-inspections to follow up with non-compliant industry establishments on previously noted violations. In situations where compliance is not offered, it is enforced through other methods, including administrative action, informational agency meetings, and legal court actions. Independently investigates routine consumer complaints. Assists other investigators in the investigation of unusual consumer complaints, Performs other duties as assigned. Analysis and Reporting: The incumbent will perform analyses and evaluation on data samples and documented information gathered during inspections and investigations to ensure that documentation and practices follow federal laws, rules, and regulations. Documents and organizes required evidence, data, and other information to support violations noted during inspections, investigations, and sample collections. Accompanies experienced inspectors to gain exposure in providing professional testimony in court cases in support of legal action. May testify as an expert witness in administrative hearings and judicial proceedings. Prepares final reports, position papers and other written documentation that support investigative findings and recommendations. Reports are developed and well-written in accordance with quality elements. Supervisory Responsibilities: This is a non-supervisory role. Requirements Conditions of Employment Qualifications In order to qualify for the Associate Investigator position which falls under the 0696 occupational Series, you must meet the following requirements by 11:59 pm EST on 11/06/2024: Basic Qualification Requirements: This Investigator job family covers professional positions that conduct inspections in FDA regulated industries and prepare and submit reports accompanied by supporting evidence documenting violations of the FD&C Act and other laws, regulations, and requirements administered by FDA. The position investigates and/or inspects FDA-regulated industry globally and evaluates compliance with U.S. laws and regulations in order to promote a culture of safety and quality with the objective of preventing unsafe, ineffective and/or defective products from becoming available to patients and consumers or used in clinical trials while facilitating appropriate development of novel products. FDA's enforcement of the laws and regulations protects patients and consumers from products that are impure, unsafe, ineffective, improperly or deceptively labeled or packaged, or in some other way dangerous or defective. Investigators routinely examine products; collect samples; conduct inspections of establishments that design, make, process, hold, or distribute FDA-regulated products; and otherwise gather information and evidence to document objectionable conditions and assess compliance with U.S. law and regulations. Investigators apply critical thinking to evaluate manufacturing processes, design practices, facility and material controls, supply chains, quality management systems, laboratory analyses, and clinical investigation programs to assess compliance with U.S. laws and regulations and to support advancements and innovations. Investigators continuously maintain required certification and credentials; provide internal and external stakeholder outreach, assistance, and education; and may mentor less experienced personnel. These positions require knowledge of various scientific fields such as biochemistry, biology, biotechnology, chemistry, data science, digital health, engineering, epidemiology, food engineering, food processing technologies, food safety, healthcare, medical technology, microbiology, nutrition, pharmaceutical science, pharmacology, public health, quality assurance, and quality management. Education/Experience Requirement: Candidates must meet the following: Education: A bachelor's degree or higher in quality assurance/management, data science, statistics, computer forensics, epidemiology, pharmacy, public health, engineering, food science, law or regulations, or related healthcare or science field. The degree must be from an accredited program or institution. To qualify for Band W candidate must have: A bachelor's degree or higher with no experience. OR Experience: To qualify for Band W without a bachelor's degree, the candidate must have at least 2 years of comparable experience. Comparable experience is defined as experience with FDA, a state or federal partner agency, or in an FDA-regulated industry or organization providing investigative or compliance services to an FDA-regulated industry, focused on evaluating or ensuring compliance with FDA or related public health laws and regulations. Desired Experience: Band W: Our ideal candidate will have experience in the following: Applying critical thinking as it pertains to a range of professional theories, concepts, principles, and methods to determine, execute, and explain actions standard practices, equipment, devices, processes, and well-known techniques and resolve a wide variety of complications and constraints contained in traditional projects. Utilizing computer applications to accomplish projects, designs, plans, and reports; to perform and interpret analyses and computations for unknown factors; and to define relationships in factual matters involving well-understood issues. Conducting and performing investigations using the scientific method including performance monitoring and quality assurance principles and conducting research by applying accepted and relevant business, and organizational practices. NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications. Education 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. 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. Education must be accredited by an accrediting institution recognized by the U.S. Department of Education in order for it to be credited towards qualifications. Therefore, provide only the attendance and/or degrees from schools accredited by accrediting institutions recognized by the U.S. Department of Education. If you are using education completed in foreign colleges or universities, see the Foreign Education section below for additional 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: 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 the U.S. Department of Education website for Foreign Education 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: National Association of Credential Evaluation Services (NACES) 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 U.S. Department of Education website for Foreign Education Evaluation. Additional Information The application limit, if applicable, for this advertisement is: No limit. Additional Conditions of Employment: Pre-employment physical required: No Drug testing required: No License required: Yes. Valid U.S. Driver's License Mobility agreement required: No Immunization required: No Bargaining Unit: National Treasury Employees Union (NTEU), 3591 Telework eligible position: Telework is at the discretion of the supervisor. This position may require financial disclosure reporting and 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. For more information please visit the FDA Ethics web page: https://www.fda.gov/about-fda/jobs-and-training-fda/ethics. Additional Information: Additional selections may be made for similar positions within the commuting area(s) of the locations listed through this vacancy announcement. Incentives may be authorized; however, this is contingent upon funds availability. If authorized, certain incentives will require you to sign a service agreement to remain in the Federal government for a period of up to 3 years. Note: This statement does not imply nor guarantee an incentive will be offered and paid. Incentives include the following: moving expenses, recruitment or relocation incentive; student loan repayment, superior qualifications appointment, creditable service for annual leave for prior non-federal work experience or prior uniformed military service, etc. If you are serving, or have served in the last 5 years (from 11/06/2024) 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. See Political Appointee FAQ - OPM for more. Applicants selected for this position will be subject to reasonable suspicion and post-accident drug testing upon hiring. To demonstrate commitment to the HHS goal of a drug-free workplace and to set an example for other Federal employees, employees not in a testing designated position may volunteer for unannounced random testing by notifying their Drug-free Federal Workplace Program Point of Contact upon hiring. All requirements must be met by the closing date of this announcement (11/06/2024); only education and experience gained by this date will be considered. You must continue to meet all requirements throughout the entire hiring process.