Version: 11/2021

Title 21 Vacancy Announcement 

Department of Health and Human Services (HHS)

Food and Drug Administration (FDA)

Office of Regulatory Affairs (ORA)

Office of Pharmaceutical Quality Operations (OPQO)

Investigator II

Application Period: October 11, 2023 – April 11, 2024

Area of Consideration: United States Citizenship is required. You must be a U.S. Citizen or U.S. 

National. Foreign nationals or legal permanent residents are not eligible for consideration.

Position: Investigator II Series: AD-0696

Location(s): Telework Eligible

Location 

Reference 

Code 

(LRC)

Openings 

per LRC

Cities within Location

PHRM1 6 

MA: Stoneham

MD: Owings Mills

NJ: Parsippany

NY: Buffalo, Jamaica 

PA: Philadelphia, Pittsburgh

PHRM2 7 

FL: Maitland, Miami

GA: College Park

NC: Raleigh-Durham 

PR: San Juan

TN: Memphis, Nashville

TX: Dallas, Houston

PHRM3 4 

IL: Chicago

IN: Indianapolis 

KY: Louisville

MI: Detroit, Grand Rapids

MN: Minneapolis

MO: Maplewood

OH: Cincinnati

WI: Wauwatosa

PHRM4 8 

CA: Alameda, Irvine, Long Beach,

Ontario, Woodland Hills 

CO: Lakewood

WA: Bothell

Salary: Starting at: $82,764 (Band A)

 $99,200 (Band B) 

Work Schedule: Full Time

Title 21 Band(s): Band A

Full Performance Band Level: Band B

Travel Requirements: 25% to 50% 

travel

Bargaining Unit: This is a bargaining 

unit position.
2 

This position is being filled under a stream-lined hiring authority, Title 21, Section 3072 of the 

21st Century Cures Act. The candidate selected for this position will serve under a career or 

career-conditional appointment and be paid under the provisions of this authority.

Additional information on 21st Century Cures Act can be found here:

21st Century Cures Act Information

Introduction

The Food and Drug Administration is the regulatory, scientific, public health, and 

consumer protection agency responsible for ensuring that all human and animal drugs, and 

medical devices are safe and effective, that cosmetics, foods, food additives, drugs and 

medicated feeds for food producing animals, and radiation emitting devices are safe, and that 

all such products marketed in the United States are adequately, truthfully and informatively 

labeled and safely and properly stored, transported, manufactured packaged and regulated. 

FDA’s programs are national in scope and effect, and the agency’s activities have a direct and 

significant impact on multi-billion-dollar industries, in addition to protecting the health and 

safety of American Consumers. The work of the Agency is carried out by a staff of more than 

18,000 scientists, physicians, regulatory and other personnel stationed throughout the United 

States. 

The mission of the Office of Regulatory Affairs is to protect consumers/patients and enhance 

public health by ensuring timely access to safe, quality FDA-regulated products. To view our 

ORA Vision, Mission, and Values, please visit: https://www.fda.gov/aboutfda/fdaorganization/office-regulatory-affairs. 

The Office of Regulatory Affairs (ORA) is at the forefront of building a public health safety net 

for today’s complex, global regulatory environment. ORA professionals work in a range of 

program areas and locations, with 227 offices and 12 laboratories throughout the United 

States. As the lead office for all FDA field activities, ORA serves as the agency’s direct 

connection with regulated industry through a) inspections of firms and plants producing FDAregulated products, b) investigations of consumer complaints, emergencies and criminal 

activity, c) enforcement of FDA regulations, d) sample collection and analysis, and e) review of 

imported products.

The Office of Pharmaceutical Quality Operations (OPQO) coordinates domestic and foreign 

inspectional, quality, and investigational activities across the field and at headquarters. In 

addition, OPQO works closely with the Center for Drug Evaluation & Research (CDER) and the 

Center for Veterinary Medicine (CVM) on compliance and enforcement activities and to 

implement policies related to the pharmaceutical program such as the Food & Drug 

Administration Safety & Innovation Act (FDASIA), Drug Quality & Safety Act (DQSA), 

Prescription Drug User Fee Act (PDUFA) and the Generic Drug User Fee Act (GDUFA).

Duties/Responsibilities

The Investigator II has demonstrated and is recognized for a high level of competence in the full 
3

range of establishments regulated within the OPQO program. Assignments involve conducting 

regulatory inspections and in-depth investigations of various industry establishments, such as 

manufacturers, re-packers, own label distributors, and importers. Investigations and 

inspections are necessary to ensure compliance with FDA laws, policies and regulations related 

to the pharmaceutical programs. 

The Investigator II performs 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.

Inspections, Investigations, Analysis, and Reporting:

• Investigator independently conducts objective surveys and emergency activities where 

precedents are lacking, and inspection program and guidelines are frequently outdated, 

too broad, or in some other way inadequate. 

• Independently plans and conducts regulatory inspections and in-depth investigations of 

various industry establishments. Assignments are frequently complicated by a variety of 

diverse products, ingredients, and additives; highly specialized and sophisticated 

processes and equipment; products that are unstable; complex quality control systems, 

or uncooperative establishment management.

• 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.

• Assists the immediate supervisor or a team leader by planning inspections, 

investigations, sample collections, and related activities in assigned responsibility.

• Performs 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, or sample collections.

• Serves as the compliance and enforcement officer with non-compliant industry 

establishments on previously noted violations. Enforcement methods include 

administrative/legal court actions and informational agency meetings.

• Serves as an instructor providing investigation and inspection training to lower graded 

trainees. Assist in training state and local government officials to ensure compliance 

with federal laws. 

• Interacts with team members in generating scientific and technical data to draft 

correspondence and reports relevant to recent inspections/investigations.

• Interacts with and advises various levels of officials representing the establishments 

subject to regulatory review. 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.
4 

• Prepares final reports, position papers and other written documentation that support 

investigative findings and recommendations.

• Advises supervisor on potentially controversial inspections and investigations that 

require additional monitoring or legal action.

Supervisory Responsibilities: This is a non-supervisory role.

Conditions of Employment

• U.S. Citizenship requirement or proof of being a U.S. National must be met by closing date.

• Employment is subject to the successful completion of a background investigation, 

verification of qualifications, completion of onboarding forms, submission of required 

documents, and any other job-related requirement before or after appointment.

• Applicants must meet all qualification requirements by the closing date of this 

announcement. 

• 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.

• One-year probationary period may be required. 

• Financial Disclosure may be required.

• Ethics Clearance may be required. 

• Background Investigation/Security Clearance is required. 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 later.

Qualifications

To be placed into a Title 21 position, candidates must meet the following criteria:

1. Scientific, Technical, and Professional Fields

2. Qualified and Outstanding Candidates

a. Outstanding candidates can be defined by existing outstanding work experience, 

outstanding performance rating, or both.

b. Qualified applies to all candidates for Title 21 appointments. 

To qualify for this Title 21 position, the candidate(s) must meet the following required

qualifications. Please note: Additional education and experience listed that is not indicated as 

required is preferable and desired. Candidates who do not meet the “desired” criteria will not be 

excluded from consideration for this position. 

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 
5 

degree was obtained. 

Experience/Education 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. 

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.

Position requirement: 

• This position requires the incumbent to have a valid driver’s license to drive a 

government or privately owned motor vehicle.  

• Able to travel up to 50% to various manufacturing sites across the US and abroad which 

may require Investigator to be away from the duty station for up to two to three weeks 

at a time.

• Must meet physical demands of assignments conducting physical plant inspection. 

These assignments will require the climbing of staircases, working on wet floors, 

working in coolers, working in freezers, working in extreme heat, i.e., around retort 

cookers, and incidences when working with dangerous cleaning chemicals and unknown 

compounds. 

Desired Education: Advanced Degree

Desired Experience: 

BAND A: Our ideal candidate will have:

• Knowledge and skill in applying a wide range of complex professional theories, concepts, 

principles, standards, and methods to determine, execute, and explain actions that 

modify standard practices, equipment, devices, processes, and well-known techniques 

and resolve a wide variety of complications and constraints contained in traditional 

projects.

• Skill to adapt precedents and existing strategies which allow occupational projects to 

meet unusual needs or demands and serves as a principal contributor for the assigned 

specialty areas on team-based projects.

• Ability to coordinate a team project by providing technical oversight and direction for a 
6 

variety of principal team members representing related professional disciplines, and 

evaluates and presents plans, designs, reports, and correspondence concerning projects 

and product issues

• Knowledge of and skill in selecting, adapting, and applying investigative methods and 

negotiating techniques to conduct complete and professional inspections and 

investigations, persuade reluctant persons and officials to provide information or access 

to information, and persuade industry representatives to agree to terms needed to 

achieve compliance

• Skill in planning and carrying out assignments, resolving most conflicts that arise, 

coordinating the work with others as necessary, and interpreting policy on own initiative 

in terms of established objectives. In some assignments, the employee also determines 

the approach to be taken and the methodology to be used. The employee keeps the 

supervisor informed of progress and potentially controversial matters

• Ability to apply judgment in interpreting and adapting guidelines, such as agency 

policies, regulations, precedents, and work directions for application to specific cases or 

problems. The employee analyzes results and recommends changes. Skilled in making 

decisions to assess unusual circumstances, variations in approach, and incomplete or 

conflicting data

BAND B: In addition to the skills/experience listed for Band A, the ideal candidate for Band B 

will also have the following skills and experience:

• Skill in planning, conducting, and leading highly technical, complex, and multi-faceted

inspections and in-depth investigations related to the production, control and testing of 

pharmaceutical products, and skill in interview and investigation techniques.

• Skills in analyzing and evaluation complex data samples and documented information 

gathered during inspections and investigations and utilizes novel approaches as needed 

to ensure compliance with federal laws, rules, and regulations.

• Ability to prepare final Establishment Inspection Report (EIR), investigations memoranda 

and proposed or final endorsements for inspections and investigations.

• Ability to evaluate and make recommendations on the state of compliance of a 

firm/individual involved in pharmaceutical, or other FDA regulated product 

manufacturing.

Education Transcripts

SUBMITTING YOUR TRANSCRIPTS: Positions which are scientific or technical in nature often 

have very specific educational requirements. A transcript is required to verify educational 

achievement. 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 FDA 

employee, you are not exempt from transcript requirements.

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 
7 

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 more information about this requirement, please visit the U.S. Department of 

Education website for Foreign Education Evaluation. 

Security Clearance Requirements

Background Investigation/Security Clearance Requirements: If not previously completed, a

background security investigation will be required for all appointees. Appointment will be

subject to the applicant’s successful completion of a background security investigation and

favorable adjudication. Failure to successfully meet these requirements may be grounds for

appropriate personnel action. In addition, if hired, a background security investigation or

supplemental investigation may be required later. 

Ethics Clearance Requirements

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. 

Equal Employment Opportunity 

The United States Government does not discriminate in employment based on race, color, 

religion, sex (including pregnancy and gender identity), national origin, political affiliation, 

sexual orientation, marital status, disability, genetic information, age, membership in an 

employee organization, retaliation, parental status, military service, or other non-merit factor.

Equal Employment Opportunity (EEO) for federal employees & job applicants

Reasonable Accommodation

Federal agencies must provide reasonable accommodation to applicants with disabilities where 

appropriate. Applicants requiring reasonable accommodation for any part of the application 

process should follow the instructions in the job opportunity announcement. For any part of 

the remaining hiring process, applicants should contact the hiring agency directly. 

Determinations on requests for reasonable accommodation will be made on a case-by-case 

basis. A reasonable accommodation is any change to a job, the work environment, or the way 

things are usually done that enables an individual with a disability to apply for a job, perform 

job duties or receive equal access to job benefits. Under the Rehabilitation Act of 1973, federal 

agencies must provide reasonable accommodations when: An applicant with a disability needs 

an accommodation to have an equal opportunity to apply for a job. An employee with a 

disability needs an accommodation to perform the essential job duties or to gain access to the 

workplace. An employee with a disability needs an accommodation to receive equal access to 

benefits, such as details, training, and office-sponsored events. You can request a reasonable 

accommodation at any time during the application or hiring process or while on the job. 
8 

Requests are considered on a case-by-case basis. Learn more about disability employment and 

reasonable accommodations or how to contact an agency.

E-Verify

The Food and Drug Administration participates in the USCIS Electronic Employment Eligibility 

Verification Program (E-Verify). E-Verify helps employers determine employment eligibility of 

new hires and the validity of their Social Security numbers.

Additional Information

Incentives may be authorized; however, this is contingent upon availability of funds. If 

authorized, certain incentives will require you to sign a service agreement to remain in the 

Federal government for a period of up to 4 years. 

Note: This statement does not imply nor guarantee an incentive will be offered and paid. 

Incentives may include recruitment or relocation incentives in accordance with FDA, Title 21 

Policy.

How to Apply

Applications will be accepted by all qualified applicants. Please send letter of interest 

addressing your experience in the major duties and responsibilities of the position and 

preferred location(s), detailed current resume, SF-50 (redacted for SSN and birth year, for 

federal employees only), and college transcript(s) (with foreign credentials evaluation, if 

applicable) to ORA Investigator Hiring: ORAInvestigatorHiring@fda.hhs.gov. Applications will be 

accepted through April 11, 2024. 

IMPORTANT: Applicants must show this job reference ID in the email subject line: 8-Inv IIOPQO-Location Reference Code(s). E.g., 8-Inv II-OPQO-PHRM1, PHRM3. 

Announcement Contact

For questions regarding this Title 21 position, please contact: 

ORAInvestigatorHiring@fda.hhs.gov.

The Department of Health and Human Services is an equal opportunity employer with a smoke 

free environment.

FDA is an equal opportunity employer.