Investigator II

HIRING IN MULTIPLE LOCATIONSLocation(s): Telework EligibleLocation Reference Code (LRC)Openings per LRCCities within LocationPHRM16MA: StonehamMD: Owings MillsNJ: ParsippanyNY: Buffalo, JamaicaPA: Philadelphia, PittsburghPHRM27FL: Maitland, MiamiGA: College ParkNC: Raleigh-DurhamPR: San JuanTN: Memphis, NashvilleTX: Dallas, HoustonPHRM34IL: ChicagoIN: IndianapolisKY: LouisvilleMI: Detroit, Grand RapidsMN: MinneapolisMO: MaplewoodOH: CincinnatiWI: WauwatosaPHRM48CA: Alameda, Irvine, Long Beach, Ontario, Woodland HillsCO: LakewoodWA: Bothell

This position is being filled under a stream-lined hiring authority, Title 21, Section 3072 of the21st Century Cures Act. The candidate selected for this position will serve under a career orcareer-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

IntroductionThe Food and Drug Administration is the regulatory, scientific, public health, andconsumer protection agency responsible for ensuring that all human and animal drugs, andmedical devices are safe and effective, that cosmetics, foods, food additives, drugs andmedicated feeds for food producing animals, and radiation emitting devices are safe, and thatall such products marketed in the United States are adequately, truthfully and informativelylabeled 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 andsignificant impact on multi-billion-dollar industries, in addition to protecting the health andsafety of American Consumers. The work of the Agency is carried out by a staff of more than18,000 scientists, physicians, regulatory and other personnel stationed throughout the UnitedStates.

The mission of the Office of Regulatory Affairs is to protect consumers/patients and enhancepublic health by ensuring timely access to safe, quality FDA-regulated products. To view ourORA 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 netfor today’s complex, global regulatory environment. ORA professionals work in a range ofprogram areas and locations, with 227 offices and 12 laboratories throughout the UnitedStates. As the lead office for all FDA field activities, ORA serves as the agency’s directconnection with regulated industry through a) inspections of firms and plants producing FDA regulated products, b) investigations of consumer complaints, emergencies and criminalactivity, c) enforcement of FDA regulations, d) sample collection and analysis, and e) review ofimported products.

The Office of Pharmaceutical Quality Operations (OPQO) coordinates domestic and foreigninspectional, quality, and investigational activities across the field and at headquarters. Inaddition, OPQO works closely with the Center for Drug Evaluation & Research (CDER) and theCenter for Veterinary Medicine (CVM) on compliance and enforcement activities and toimplement policies related to the pharmaceutical program such as the Food & DrugAdministration Safety & Innovation Act (FDASIA), Drug Quality & Safety Act (DQSA),Prescription Drug User Fee Act (PDUFA) and the Generic Drug User Fee Act (GDUFA).Duties/ResponsibilitiesThe Investigator II has demonstrated and is recognized for a high level of competence in the fullrange 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 ApplyApplications 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 II-OPQO-Location Reference Code(s). E.g., 8-Inv II-OPQO-PHRM1, PHRM3.

Announcement ContactFor 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.