Investigator II/Senior Investigator I

Duties/Responsibilities
The Investigator/Senior Investigator has demonstrated and is recognized for a high level of competence in the full range of establishments regulated within the OMDRHO program such as: inspections and investigation of manufacturers, specification developers, contract manufacturers, sterilizers, initial importers, and distributors.
Assignments involve a combination of scientific and regulatory responsibilities which usually call for several atypical inspectional or intensive investigative approaches to be applied to a wide variety of regulatory functions or scientific evaluations, and include the most difficult and complex sample collections, establishment inspections, unusual or novel special investigations and conducting objective surveys and emergency activities within the assigned area of responsibility.
Inspection and Investigation
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Independently plans and conducts regulatory inspections and in-depth investigations of various industry establishments, such as manufacturers, specification developers, contract manufacturers, sterilizers, initial importers, and distributers. Assignments are frequently complicated by a variety of diverse products, highly specialized and sophisticated processes and equipment, products that are misbranded or adulterated or unapproved, complex quality control systems, or uncooperative establishment management. The Investigator conducts inspections and investigations (domestic and/international) of facilities where only limited guidance documents are available, proposed or new regulations must be used to evaluate the industry, or the inspection or investigation may result in considerable attention and review in the media, Congress, or other forces inside or outside the Agency.
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Incumbent performs various activities including domestic sample collections, establishment inspections, unusual or novel special investigations, remote regulatory assessments (RRAs), recall audit checks, and emergency activities of moderate difficulty within the incumbent's assigned area of responsibility.
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Incumbent interacts with and advises various levels of management officials representing the regulated industry, associations, state, local and foreign governments including those which may be contentious and require special skills to moderate conversations.
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The incumbent initiates contact with industry officials to obtain basic incomplete or missing information on regulatory and scientific documents and to discuss the status of investigations.
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Assists the immediate supervisor or a team leader by planning inspections, investigations, sample collections, and related activities in the area of assigned responsibility, trains new personnel and providing training for personnel, trains State and local government personnel and when required, conducts international inspections.
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Performs investigations involving complaints of illness, injury, or death attributable to products regulated by the FDA.
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Judgment must be used to make field decisions on the nature and extent of investigations and inspections. Incumbent conducts re-inspections to follow up with non-compliant industry establishments on previously noted violations.
Analysis and Reporting
Incumbent performs analyses and evaluation on potentially complex data samples and documented information gathered during inspections and investigations, utilizing novel approaches as needed to ensure compliance with Federal laws, rules, and regulations. Documents and organizes required evidence, data, and other information to support violations noted during inspections, RRAs, investigations and sample collections. Interacts with and advises various levels of officials representing the establishments subject to regulatory review. Initiates contact with industry officials and manufacturers to obtain basic, incomplete, or missing information on regulatory and scientific documents, to discuss the status of investigations, and to attend meetings and conference calls.
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Prepares final EIR, investigations memoranda, and proposed or final endorsements for inspections and investigations conducted. Reports are developed and well-written in accordance with quality elements.

Education Requirement: The education must have been obtained at a college, university, or an accrediting body recognized by the Secretary, U.S. Department of Education at the time the degree was obtained.
Basic Requirements:
Applicants must meet one of the following requirements.
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.
OR
Experience: Comparable 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. To qualify for Band A with no degree, you must have at least 4 years of comparable experience. To qualify for Band B with no degree, you must have at least 5 years of comparable experience.