Sanitarian I

Job Description:
Sanitarian I

**PLEASE NOTE: The posted salary range is the full range for this position. Agency salary policy, budget and candidate’s qualifications will dictate final salary offer. Typically, salary offers are at or near the midpoint of the range, depending on qualifications or other factors.**

Sanitarian I or Environmental Protection Specialist I (understaffed Sanitarian I) - - Most inspections will be conducted in Dallas/Ft. Worth (DFW) and surrounding areas with frequent travel to East and West Texas.

Under the supervision of the Drugs and Medical Devices Manager, works independently with full professional competence to perform highly technical, complex federal contract and non-contract inspections of wholesale prescription drug/device manufacturers and distributors; wholesale over the counter drug/device manufacturers and distributors; salvage establishments and brokers; cosmetic manufacturers and distributors for which the division is responsible for compliance with the Texas Food, Drug, and Cosmetic Act and the Good Manufacturing Practices Regulations. Investigates illegal activities involving drug/device manufacturers and distributors. Responds to complaints and disasters involving drug/device manufacturers and distributors; collects necessary samples; and prepares highly technical reports documenting inspectional findings. Uses initiative and independent judgment in performing duties. Employee actively participates and/or serves in a supporting role to meet the agency's obligations in response and/or recovery in Continuity of Operations (COOP) activation. Essential Job Functions:
Attend work on a regular and predictable schedule in accordance with agency leave policy and performs other duties as assigned.

(65%) Performs highly technical, complex federal contract and non-contract inspections of drug manufacturers, drug wholesalers, device/drug/cosmetic salvage establishments and brokers, device distributors, device manufacturers, and cosmetic manufacturers/distributors for which the Division is responsible for compliance with the Texas Food, Drug, and Cosmetic Act and the Good Manufacturing Practices Regulations. Uses assorted inspectional equipment. Supports objectionable conditions using such documentation as samples, photographs, filth exhibits, and written records. Completes detentions and destructions according to Division policy. Completes and issues a written notice of observation for inspected facilities prior to completing the inspection. Prepares highly technical and detailed inspection reports for all establishment inspections. Utilizes word processing, databases and spreadsheet software and a laptop computer to complete inspection reports and submit the reports according to Division policy for review and possible regulatory action.

(10%) Investigates complaints involving drug manufacturers, drug wholesalers, device/drug/cosmetic salvage establishments and brokers, device distributors, device manufacturers, and cosmetic manufacturers/distributors and prepares detailed reports of findings. Investigates disease outbreaks and documents findings. Conducts special investigations involving drug and medical device imports, disasters, special sampling assignments, and other special assignments as directed. Provides training to assigned drug manufacturers, drug wholesalers, device/drug/cosmetic salvage establishments and brokers, device distributors, device manufacturers, and cosmetic manufacturers/distributors investigators, including joint field inspections and review of inspection reports.

(10%) Provides information and assistance on drug and medical device related subjects as requested by citizens, regulated industry, and other local, state and federal agencies. Prepares technical presentations on applicable subject for Division training programs, as requested. Participates in available educational programs and training presented by the division, the U.S. Food and Drug Administration, the Department, and additional outside training as directed by the Division or supervisor.

(5%) Participates in regulatory actions including presenting technical information regarding inspections and gives testimony during hearings and court trials; prepares special reports, summaries, and exhibits for use by counsel during hearings and trials.

(5%) Completes electronic travel reports, monthly activity reports, time sheets, and other Division and Department reports as required. Safe operation of either a state-owned vehicle or personal vehicle is required to conduct state business and acceptable driving record must be maintained.

(5%) Other duties as assigned. Use of safety equipment is required. Knowledge Skills Abilities:
Knowledge of the theory and practical applications of disciplines to include microbiology, biology, biochemistry, chemistry, epidemiology, statistics, thermodynamics, nutrition, and food toxicology.

Knowledge and skill in selecting, adapting, and applying investigative methods and negotiating techniques to conduct complete and professional inspections.

Knowledge of State and federal drug and medical device laws and regulations covering the various types of drug manufacturers, drug wholesalers, device/drug/cosmetic salvage establishments and brokers, device distributors, device manufacturers, and cosmetic manufacturers/distributors.

Knowledge of applicable parts of the Code of Federal Regulations, Texas Food, Drug and Cosmetic Act, Texas Administrative Code and the Good Manufacturing Practices Regulation.

Knowledge and skill in selecting, adapting, and applying investigative methods and negotiating techniques to conduct, complete and professional inspections.

Knowledge of the technical aspects of inspections of various types of drug manufacturers, drug wholesalers, device/drug/cosmetic salvage establishments and brokers, device distributors, device manufacturers, and cosmetic manufacturers/distributors, and equipment utilized by these facilities and the equipment for conducting inspections (notebook computer, digital camera, black light, etc.)

Skill in verbal and written communication, including writing detailed technical reports.

Skill in word processing, database, and spreadsheet software for submission of written correspondence, reports and presentations.

Skill to make appropriate field decisions and to plan how the investigation should proceed to resolve difficult and sensitive situations.

Ability to organize and prioritize workload to meet deadlines.

Ability to exercise good professional judgment in evaluating situations and making decisions. Mature judgment must be used to make field decisions and to plan how the investigation should proceed to resolve difficult and sensitive situations.

Ability to communicate effectively with regulated industry and the public.

Ability to plan, prepare and present technical programs related to food safety.

Ability to deal tactfully and effectively with co-workers, managers, the public and regulated industry.

Ability to maintain confidentiality of information and documents where appropriate.

Ability to perform inspectional work which may require using ladders or catwalks to access equipment, lifting/carrying up to 50lbs, pulling/pushing up to lbs. and standing for extended periods of time.

Ability to identify rodent and insect filth in dimly lighted areas during inspections.

Ability to review and understand documentary evidence such as invoices and records relating to drug manufacturers, drug wholesalers, device/drug/cosmetic salvage establishments and brokers, device distributors, device manufacturers, and cosmetic manufacturers/distributors.

Ability to provide own transportation for the purpose of conducting inspections and receiving training.

Ability to occasionally work outside normal duty hours and adjust work week to accommodate workload, and to be available for emergency or disaster response involving food or drugs (24 hours on call).

Ability to travel as needed to satisfy program needs.

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