Investigator I

In order to qualify for the Investigator I 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 Y candidate must have: A bachelor’s degree and 1 year of comparable experience; or A master’s degree or higher with no experience; or Without a bachelor’s degree, the candidate must have at least 3 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 Y: Our ideal candidate will have experience in the following: Applying a professional, concepts, principles, and methodology sufficient to research, analyze, interpret, evaluate, and carry out difficult but conventional assignments; to determine relevancy and use of aesthetic, factual, economic, financial, and professional information; and to prepare and evaluate conventional plans, designs, specifications, and related documentation. Conducting and performing analytical investigations using the scientific method including performance monitoring and quality assurance principles and conducting research by applying accepted and relevant business, marketing, and organizational practices. Identifying serious public health hazards where timeliness and departure from the usual procedures are essential. Performing special investigations under detailed instructions, for example, tracing reports of contamination and collecting appropriate samples for laboratory examination. Accompanying experienced investigators to gain exposure and interaction with Importer, Brokers, Carriers, and other government agencies such as Customs and Border Protection. NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications.
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 Y (GS-09 equivalent).