FDA Hiring for Investigator II at United States Full Time

**HIRING IN MULTIPLE LOCATIONS**

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

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/

fda organization/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 FDA regulated 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

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.

• 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.

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: [email protected]. Applications will be accepted through April 11, 2024.

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

Announcement Contact

For questions regarding this Title 21 position, please contact: [email protected].

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

FDA is an equal opportunity employer.