Sanitarian III

Texas Health & Human Services Commission • Austin, TX

8d • $4,801 - $7,762 • Hybrid

About The Position

Under the direction of the Branch Manager, this position oversees and monitors activities of the drug and medical device program personnel. It requires full professional competence in carrying out inspections and investigations, analyzing information and developing logical conclusions. This position will assist with oversight and monitoring of all complaints received and investigated regarding drug and medical device program areas. It entails co-responsibility for the planning of inspections and involves preparation of special reports and correspondence related to program activities. This position reviews, edits, and endorses staff inspection reports, interprets drug and medical device program rules, regulations, policies and procedures for applicants, industry, the general public and governmental agencies via written and/or verbal communications. Provides training to program personnel and consults with private industry, professional groups, law enforcement and other governmental agencies. Recommends program enforcement actions, to include litigation, as directed by Central Office supervisory personnel. Assists with program-related compliance activities and directed investigations. Performs emergency response functions and participates in emergency and actual emergency responses as required.

EJF #1: Serves as a Sanitarian III by providing oversight and coordination of program regulatory activities for drug and medical device programs by reviewing staff reports, and monitoring complaints to assure compliance with State and Federal rules and regulations. Coordinates program activities with department staff, State and Federal agencies, local health officials and key stakeholder organizations to review operational processes and procedures, identify barriers, and execute solutions as needed to ensure that program regulations are implemented effectively. Develops policies and standard operating procedures for each program as needed; establishes and follows criteria for inspection report review and endorsement; sets standards for receiving and responding to public complaints and requests; and ensures that all complaints are investigated and resolved in a timely manner. Provides feedback to manager on performance goals and process improvement strategies for development and implementation of effective program policies, standards, and quality assurance methods. Communicates routinely with home-based and central office field staff. Using Versa Regulation, generates reports and queries data used in the entry and review of inspections/investigations. Using Versa Regulation, monitors complaints related to drug and medical device program areas. (35%)

EJF #2: Uses Word, Versa Regulation, Excel and/or Outlook on a personal computer, composes, edits, types, and proofreads narrative and statistical reports for special investigations and activities. Performs comprehensive technical and quality control reviews of complex inspection and complaint investigation reports conducted by regional inspection staff under regulations of the drugs and medical device program. Composes, edits, types, and proofreads correspondence suitable for signature of Commissioner, Assistant Commissioner, Section Director, or Branch Manager. Reviews and evaluates inspection and complaint outcomes and associated evidence to ensure fair and uniform application of the regulatory standards. Reviews letters of noncompliance, evaluates conditions and directs appropriate action to resolve documented inspection deficiencies. Based on review findings, may compose endorsement summaries using Microsoft Word and Excel for referral to the Compliance Unit or the Compliance Review Committee (CRC). May compose warning letters and/or initiate escalated enforcement to the CRC as needed for possible referral to the Office of the Attorney General for injunctive relief or civil penalty. May prepare and present cases to CRC, including compliance history and enforcement summaries. Oversees the resolution of enforcement cases by providing interpretations of laws and regulations to department staff and inspection staff and serves as technical resource specialist at informal settlement conferences or hearings. May coordinate follow-up inspections as needed to evaluate compliance with legal orders. May be called upon as a technical expert witness to provide testimony for legal cases. (35%)

EJF #3: Uses Microsoft PowerPoint, develops educational and training materials for program personnel. Performs field training for new staff. Consults with representatives of private industry, professional groups, law enforcement, other governmental agencies, and the general public. (10%)

EJF #4: Conducts periodic inspections of drug and medical device program establishments. Assists Branch Manager to ensure firms comply with the State and Federal laws pertaining to drug and medical device program areas. Tracks regulatory activities with guidance from supervisory personnel and recommends appropriate enforcement action. (10%)

EJF #5: Prepares affidavits, gives depositions for use in litigation, and testifies in court on program related matters. Compiles data and drafts language suitable for inclusion in legislative and rulemaking initiatives as they pertain to the drug and medical device programs. (5%)

EJF #6: Performs related duties as assigned, including emergency response functions and participates in emergency response training as assigned (marginal function). (5%)

Requirements

• State and federal statutes and regulations affecting the drugs and medical devices program under Health and Safety Code, Chapter 431, 432 and Chapter 481.
• Safety and general sanitation principles and practices in all firms related to the drugs and medical devices program.
• Structure and functions of local, state, and federal agencies and organizations.
• General or environmental health and safety principles, practices, and management.
• Knowledge of legislative procedures and agency rule-making processes.
• Natural sciences, particularly biology and chemistry.
• Understanding and interpreting relevant statutes and regulations.
• Technical, writing, training, teaching, public speaking, and risk communication.
• The use of various software programs, including Microsoft Word, Excel, PowerPoint, and Outlook.
• Work effectively as a team leader in an environment of change.
• Effectively coordinate work activities between teams to complete projects.
• Organize staff resources and workloads to implement project goals and objectives.
• Develop long range plans and goals for highly technical programs.
• Accurately interpret regulatory statutes, rules, policies, and procedures, and to respond to inquiries from both internal and external customers.
• Assemble, correlate, and analyze data and facts to develop reports and to devise solutions to problems.
• Use proper inspection procedures and logic pathways to determine compliance status.
• Communicate technical information effectively, and to prepare and present highly technical information to professional groups and the public.
• Adhere to agency policies and procedures.
• Work independently with minimal supervision and to make sound decisions.
• Work effectively and cooperatively with co-workers, teams, supervisor, managers, the regulated community, the public, and professionals at all levels of government and industry.
• Be tactful and diplomatic in adverse situations.
• Travel as necessary to attend technical training courses, to perform outreach, to perform inspections, and to conduct training.
• Possession of a current State of Texas sanitarian registration.
• Bachelor’s degree from an accredited college or university.

Nice To Haves

• Two or more years of experience in reading and interpreting laws and rules and offering guidance to industry, public, or local health departments.
• Two or more years inspection or compliance experience within a Drugs and Medical Device program.

Responsibilities

• Oversees and monitors activities of the drug and medical device program personnel.
• Carries out inspections and investigations, analyzes information and develops logical conclusions.
• Assists with oversight and monitoring of all complaints received and investigated regarding drug and medical device program areas.
• Co-responsibility for the planning of inspections.
• Prepares special reports and correspondence related to program activities.
• Reviews, edits, and endorses staff inspection reports.
• Interprets drug and medical device program rules, regulations, policies and procedures for applicants, industry, the general public and governmental agencies via written and/or verbal communications.
• Provides training to program personnel.
• Consults with private industry, professional groups, law enforcement and other governmental agencies.
• Recommends program enforcement actions, to include litigation, as directed by Central Office supervisory personnel.
• Assists with program-related compliance activities and directed investigations.
• Performs emergency response functions and participates in emergency and actual emergency responses as required.
• Provides oversight and coordination of program regulatory activities for drug and medical device programs by reviewing staff reports, and monitoring complaints to assure compliance with State and Federal rules and regulations.
• Coordinates program activities with department staff, State and Federal agencies, local health officials and key stakeholder organizations to review operational processes and procedures, identify barriers, and execute solutions as needed to ensure that program regulations are implemented effectively.
• Develops policies and standard operating procedures for each program as needed.
• Establishes and follows criteria for inspection report review and endorsement.
• Sets standards for receiving and responding to public complaints and requests.
• Ensures that all complaints are investigated and resolved in a timely manner.
• Provides feedback to manager on performance goals and process improvement strategies for development and implementation of effective program policies, standards, and quality assurance methods.
• Communicates routinely with home-based and central office field staff.
• Generates reports and queries data used in the entry and review of inspections/investigations using Versa Regulation.
• Monitors complaints related to drug and medical device program areas using Versa Regulation.
• Composes, edits, types, and proofreads narrative and statistical reports for special investigations and activities using Word, Versa Regulation, Excel and/or Outlook.
• Performs comprehensive technical and quality control reviews of complex inspection and complaint investigation reports conducted by regional inspection staff under regulations of the drugs and medical device program.
• Composes, edits, types, and proofreads correspondence suitable for signature of Commissioner, Assistant Commissioner, Section Director, or Branch Manager.
• Reviews and evaluates inspection and complaint outcomes and associated evidence to ensure fair and uniform application of the regulatory standards.
• Reviews letters of noncompliance, evaluates conditions and directs appropriate action to resolve documented inspection deficiencies.
• May compose endorsement summaries using Microsoft Word and Excel for referral to the Compliance Unit or the Compliance Review Committee (CRC).
• May compose warning letters and/or initiate escalated enforcement to the CRC as needed for possible referral to the Office of the Attorney General for injunctive relief or civil penalty.
• May prepare and present cases to CRC, including compliance history and enforcement summaries.
• Oversees the resolution of enforcement cases by providing interpretations of laws and regulations to department staff and inspection staff and serves as technical resource specialist at informal settlement conferences or hearings.
• May coordinate follow-up inspections as needed to evaluate compliance with legal orders.
• May be called upon as a technical expert witness to provide testimony for legal cases.
• Develops educational and training materials for program personnel using Microsoft PowerPoint.
• Performs field training for new staff.
• Conducts periodic inspections of drug and medical device program establishments.
• Assists Branch Manager to ensure firms comply with the State and Federal laws pertaining to drug and medical device program areas.
• Tracks regulatory activities with guidance from supervisory personnel and recommends appropriate enforcement action.
• Prepares affidavits, gives depositions for use in litigation, and testifies in court on program related matters.
• Compiles data and drafts language suitable for inclusion in legislative and rulemaking initiatives as they pertain to the drug and medical device programs.
• Performs related duties as assigned, including emergency response functions and participates in emergency response training as assigned.

Benefits

• Insurance coverage and other benefits available through the State of Texas Group Benefits Plan administered by the Employee Retirement System of Texas (ERS).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level