Investigator I

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 Y (GS-09 equivalent).

Duties

As Investigator I, 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

• U.S. Citizenship requirement or proof of being a U.S. National must be met by closing date.
• The candidate selected for this position will serve under a career or career-conditional appointment within the competitive service.
• 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.
• 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.

• Males born after December 31, 1959, must be registered with the Selective Service. Please go to http : / / www.sss.gov for more information.
• One-year probationary period may be required.
• Financial Disclosure may be required.
• Ethics Clearance may be required.
• 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.

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.

• This position requires the incumbent to have the following current license and / or certification : Must possess a valid driver’s license to drive a government or privately owned motor vehicle.
• Candidates for this position must complete a statement regarding their physical ability and may be required to undergo physical examination.
• Position may include shift work and / or weekend work.
• Travel approximately 25-50 percent of the time, which may require the investigator to be away from the duty station for up to two to three weeks at a time.

Qualifications

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.

How You Will Be Evaluated

You will be evaluated for this job based on how well you meet the qualifications above.

This is a Title 21 announcement. Traditional rating and ranking of applications, and veterans' preference does not apply to this vacancy.

You will be evaluated against the basic qualifications and if found qualified, you will be referred to the Hiring Manager for consideration.

If you are referred to the hiring manager for consideration , you may be further evaluated based on an interview; review of requested work samples, writing samples, most recent performance evaluation(s), or professional references;

or results of an oral presentation or work-related test.

Failure to comply with any of the additional assessment requirements will result in removal from further consideration.

Please follow all instructions carefully. Errors or omissions may affect your eligibility.

Required Documents

Resume : At a minimum, your resume should list the position title, employer name, start and end dates (including month and year), salary (or grade and step), hours worked per week, and a list of duties performed or accomplishments, for EACH position listed.

A CV (curriculum vitae) may not contain enough information to meet these resume requirements.

Transcripts : If the position has an education requirement or you are qualifying based on education, unofficial transcripts or a list of courses must be provided.

See the Qualifications and Education Requirements section of this announcement.

Additional Documents (if applicable) :

• Cover Letter
• DD-214 / Statement of Service
• Disability Letter (VA)
• Other supporting documentation not listed above
• Resume
• SF-15
• SF-50 / Notification of Personnel Action
• Transcript

Failure to provide all of the required information as stated in this vacancy announcement may result in an ineligible rating or may affect the overall rating.

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