QUALIFICATIONS

In order to qualify for the Investigator II position which falls under the 0696 occupational Series, you must meet the following requirements by 11:59 pm EST on 06/13/2025:
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 and/or Experience Requirement: Candidates must meet one of the following:

• Bachelor’s degree 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 AND two years of 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; -OR-
• Master’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 AND one year of 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; -OR-
• Doctorate 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-
• Four years of 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.

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.

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.

• Benefits

A career with the U.S. government provides employees with a comprehensive benefits package. As a federal employee, you and your family will have access to a range of benefits that are designed to make your federal career very rewarding. Opens in a new windowLearn more about federal benefits.

Eligibility for benefits depends on the type of position you hold and whether your position is full-time, part-time or intermittent. Contact the hiring agency for more information on the specific benefits offered.

• Required Documents

As a new or existing federal employee, you and your family may have access to a range of benefits. Your benefits depend on the type of position you have - whether you’re a permanent, part-time, temporary or an intermittent employee. You may be eligible for the following benefits, however, check with your agency to make sure you’re eligible under their policies.

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.

• Resume Writing Tutorial
• Resume Writing FAQ

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.
Professional Licensure: If the position has a licensure requirement, a copy of your professional license must be provided. See the Qualifications and Education Requirements section of this announcement.

IF YOU ARE RELYING ON YOUR EDUCATION TO MEET QUALIFICATION REQUIREMENTS:

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.

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.

• How to Apply

To apply for positions with the Food & Drug Administration, you must have a https://secure.login.gov/ account, and be signed in to that account, before you click “Apply Online”. See the USAJOBS Help Site article “How does the application process work?” for more on this process. Additionally, you must provide a resume and any required supporting documentation listed on the announcement, and you must complete all assessment questionnaires BEFORE 11:59 pm Eastern Time on the closing date of this announcement, 06/13/2025. We recommend that you start the application process early enough that you can complete and submit your application before this deadline.

ONCE THE ONLINE QUESTIONNAIRE IS RECEIVED YOU WILL RECEIVE AN ACKNOWLEDGEMENT EMAIL THAT YOUR SUBMISSION WAS SUCCESSFUL.

You will receive application status updates via email and via USAJOBS as the process unfolds.

• Fair and Transparent

The Federal hiring process is set up to be fair and transparent. Please read the following guidance.

• Criminal history inquiries
• Equal Employment Opportunity (EEO) Policy
• Financial suitability
• New employee probationary period
• Privacy Act
• Reasonable accommodation policy
• Selective Service
• Signature and false statements
• Social security number request

IF YOU ARE RELYING ON YOUR EDUCATION TO MEET QUALIFICATION REQUIREMENTS:

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.
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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DUTIES

The Investigator II conducts inspections and investigations involving a combination of scientific and regulatory responsibilities which usually call for a number of atypical inspectional or intensive investigative approaches to be applied to a wide variety of regulatory functions or scientific evaluations.

• Conducts objective surveys and emergency activities within the assigned area of responsibility. Assists the immediate supervisor or a team leader by planning inspections, investigations, sample collections, and related activities in the area of assigned responsibility; training new personnel and providing training for high graded personnel.
• Independently plans and conducts regulatory inspections and in-depth investigations of various medical products establishments. Conducts re-inspections to follow up with non-compliant industry establishments on previously noted violations.
• Inspections and Investigations Assignments involve a combination of scientific and regulatory responsibilities of atypical inspections, or intensive investigative approaches using a variety of regulatory functions or scientific evaluations; and include the more difficult and complex sample collections, establishment inspections, unusual or novel special investigations.
• Performs analyses and evaluation on data samples and documented information gathered during inspections and investigations to ensure that documentation and practices are in compliance with Federal laws, rules and regulations. Documents and organizes required evidence, data, and other information to support violations noted during inspections, investigations, sample collections or filer audits.
• Gathers scientific and technical comments from team members, assists with the preparation of letters and correspondence relevant to the review, and contributes to status reports for submissions and investigations under review.
• Interacts with and advises various levels of officials representing the establishments subject to regulatory review. Initiates contact with industry officials to obtain basic incomplete or missing information on regulatory and scientific documents and to discuss the status of investigations. Prepares final reports, position papers and other written documentation that support investigative findings and recommendations.
• Prepares final Establishment Investigation Report (EIR), investigations memoranda, and proposed or final endorsements for inspections, investigations, and filer audits conducted.

Supervisory responsibilities: This is a non-supervisory position.