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: https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/21st-century-cures-act

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/about-fda/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 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 / Senior Investigator I (GDUFA) 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 pharmaceutical programs.

The Investigator II / Senior Investigator I (GDUFA) 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.

Inspections, Investigations, Analysis, and Reporting:

Band A:

• 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 the area of assigned responsibility.

• 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, 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.

Band B:

• Conducts complex inspections and in-depth 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 FDA.

• Performs investigations involving complaints and trace-back investigations of illness, injury, or death attributable to products regulated by the FDA. Information which initiates such investigations is often minimal, unclear and the veracity unknown requiring innovation, ingenuity, and diplomacy. These situations are often unstructured and require contacts with many and diverse individuals, institutions, and firms. Expert judgment must be used to make field decisions on the nature and extent of follow-up investigations.

• Plans and decides how the investigation should proceed, when the investigation is complete, and what reporting is required. Analyzes results to finalize investigation or to determine what additional work may be required.

• Performs analyses and evaluation on the most 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.

• Prepares final establishment inspection reports, investigations memoranda, and proposed or final endorsements for inspections, investigations, and filer audits conducted. Reports are developed, and in most instances accepted with little review of format or content.

Supervisory Responsibilities: This is a non-supervisory role.

How to Apply

Applications will be accepted by all qualified applicants. United States Citizenship is required. Applicants must submit a letter of interest addressing experience in the major duties and responsibilities of the position, a detailed current resume, SF-50 (redacted for birth year and SSN – for federal employees only) and college transcript(s) showing degree was awarded (with foreign credentials evaluation if applicable). A diploma will not be accepted as part of your application. All required materials should be sent to: ORAInvestigatorHiring@fda.hhs.gov. Applications will be accepted through July 15, 2024, or until all positions have been filled.

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

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.