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Senior Investigator I
hace 3 semanas
**Duties**:
**Inspections and Investigations**
- The incumbent independently conducts complex inspections and investigations (domestic and international) and sampling at human food facilities covering all types of products and problems within the area of assigned responsibility.
- Investigates and evaluates the adequacy of complex manufacturing practices to determine compliance with Current Good Manufacturing Practices (cGMPs), Preventive Controls and other human food regulations.
- Incumbent 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 in planning inspections, investigations, sample collections, and related activities in the area of assigned responsibility; trains new personnel, monitors or manages sample collection or inspection programs, as appropriate.
- Performs investigations involving complaints and trace-back investigations of illness, injury, or death attributable to products regulated by the FDA. Investigations require special coordination and a high degree of insight and knowledge. The information which initiates such investigations is often mínimal, 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.
- Mature 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, decides when an inspection/investigation is complete or what additional work may be required.
- Incumbent interacts with and advises various levels of officials representing the regulated industry, associations, state, local and foreign governments including those which may be contentious and require special skills to moderate conversations.
- Provides timely and accurate feedback to inspectorate and headquarters management as well as effective guidance to other inspectorate staff assisting in inspections/investigations.
- Assists all Human Food Divisions in the completion of OII's workplan and other human food priorities (e.g., on the job experience, coaching).
- Performs other duties as assigned.
**Analysis and Reporting**
- The incumbent performs analyses and evaluation of data samples and documented information gathered during inspections and investigations, utilizing novel approaches as needed to ensure compliance with federal laws, rules, and regulations.
- Documents and organizes required evidence, data, and other information to support violations noted during inspections, investigations, and sample collections.
- May serve as an instructor providing investigation and inspection training to lower grade trainees. Assist in training state and local government officials to ensure compliance with federal laws.
- May testify as an expert witness in administrative hearings and judicial proceedings.
- Prepares final report, investigations memoranda, and proposed or final endorsements for inspections and investigations. Reports are developed and, in most instances, accepted with little review of format or content and in accordance with quality elements.
- Advises on potentially controversial inspections and investigations that require additional monitoring or legal action.
- May provide training to other investigators or state and local agencies in inspection and investigation techniques.
- Assist in designs of agendas for and participates in training programs for inspectorate area and industry personnel. May be assigned as a mentor of lower graded personnel to ensure they receive the correct mix of formal and on-the-job training.
- The incumbent may serve as a team leader or coordinator in the conduct of complex assignments requiring one or more investigators, analysts, outside experts, and/or personnel from other federal agencies, state, local, or foreign governments.
**Requirements**:
**Conditions of Employment**:
- U.S. Citizenship requirement or proof of being a U.S. National must be met by closing date.
- 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.
- One-year probationary period may be required.
- Financial Disclosure may be required.
- Ethics Clearance may be required.
- Position requires occasional lifting of heavy objects up to 50 lbs and may require work to be per
