Compliance Specialist

TX-HHSC-DSHS-DFPS • Austin, TX

10d • Onsite

About The Position

Under the direction of the Compliance Section Consumer Safety Branch Manager, the Program Specialist IV (Compliance Specialist) performs highly complex (senior-level) consultative services and technical assistance work for the Foods, Drugs, and Medical Devices Programs. This role involves facilitating and coordinating escalated cases in accordance with laws, regulations, and policies pertinent to each program. The specialist will consult with licensees, Department staff, attorneys, managers, and outside regulatory authorities on compliance and enforcement matters. Responsibilities include operating the Department database for data entry, reporting, case tracking, trending, and quality control. The role also involves facilitating meetings, providing technical assistance, training others on enforcement procedures, testifying in hearings, and posting final enforcement actions to websites. The position also requires serving in the Department's Disaster Response/Recovery and Support Operations as assigned and maintaining an acceptable driving record. The role operates under limited supervision with moderate latitude for initiative and independent judgment.

Requirements

• Bachelor’s degree from a U.S. accredited college/university.
• 5 years experience interpreting, and applying appropriate law and rule.
• 5 years experience developing compliance/enforcement cases.
• 5 years experience drafting lengthy reports or other documents on a regular basis.
• 5 years experience reviewing and evaluating complex reports.
• 5 years experience performing quality analysis on compliance inspections and/or investigations.
• Knowledge of the APA and its relevance to the compliance/enforcement process.
• Knowledge of the laws and regulations applicable to the Food and Drug programs.
• Knowledge of state government processes and the Department’s organization.
• Knowledge of quality assurance procedures.
• Skill in handling multiple assignments and prioritizing.
• Skill in preparing and reviewing written correspondence and reports.
• Skill in written and verbal communication.
• Proficient in the use of Microsoft office suites: Word, Excel, Outlook, and other computer applications and databases.
• Skill in conflict resolution or facilitation.
• Skill in conducting meetings.
• Ability to work effectively in a team and also independently with minimal supervision.
• Ability to manage time effectively and to exercise good judgment in evaluating situations and making recommendations.
• Ability to interpret and apply rules, regulations, policies, and procedures.
• Ability to read and analyze inspection reports and evidence and identify weak or unsupportable findings.
• Ability to make formal presentations using presentation media to large audiences.
• Ability to perform trending analyses and create reports that illustrate significant results.
• Ability to bring a wide variety of opinions to an agreement through consensus building.
• Ability to give clear and accurate testimony under oath.
• Ability to present complex regulatory information effectively to a wide variety of audiences.

Nice To Haves

• Active Duty, Military, Reservists, Guardsmen, and Veterans: Military occupation(s) that relate to the initial selection criteria and registration or licensure requirements for this position may include, but not limited to those listed in this posting.

Responsibilities

• Facilitates and processes escalated cases according to Section policy.
• Responsible for posting final enforcement actions to Department website and other affiliated regulatory websites.
• Reviews investigative reports and escalated cases from the Food, Drug, and Medical Devices Programs to examine deficiencies and the underlying evidence.
• Interprets and applies appropriate law and rule and determines if disciplinary action(s) should be assessed or if additional information is needed.
• Maintains history of penalty assessments and case resolution decisions to keep program consistent.
• Writes Notices of Violation (NOV), in accordance with the Administrative Procedures Act (APA).
• Drafts orders (agreed, default, etc.) that memorialize the details of escalated case resolution such as facts, violations, and terms of settlement.
• Drafts other documents such as memoranda, reports, presentations, letters, and emails.
• Applies good case management techniques to handle large caseloads efficiently.
• Manages multiple assignments with competing priorities.
• Works independently or in a team environment to complete assignments.
• Consults with licensees, Department staff, attorneys, managers, and outside regulatory authorities, as necessary, on compliance/enforcement matters.
• Responds to routine rule inquiries by phone, email, or face-to-face meeting.
• Elevates unresolvable impasse to upper management where necessary.
• Works cooperatively with program staff and managers to acquire necessary information for processing compliance/enforcement escalated cases.
• May participate in independent board meetings.
• Uses Department database for data entry, running reports, case tracking, trending of data, updates, and quality control.
• Performs quality assurance on compliance/enforcement cases as directed and assists in the processing of Open Records Requests (ORR).
• Facilitates meetings with Department staff, managers, attorneys, licensees, and others.
• Facilitates the Compliance Review Committee (CRC) where escalated cases are reviewed, and consensus decisions are reached on the legal sufficiency of cases and the appropriate sanctions or penalties to propose.
• Organizes, schedules, and conducts informal conferences (IC) with the respondent and their attorney, with attendance by program staff, the program attorney, and Department managers to seek consensus agreement for resolving the cases informally, in accordance with the Administrative Procedure Act (APA).
• Arranges for formal hearings at SOAH when cases cannot be resolved informally.
• Provides technical assistance on compliance/enforcement matters.
• Responds to inquiries from various sources.
• Collects, organizes, and prepares materials in response to requests for information.
• Participates in staff meetings and presents regulatory information as needed.
• Trains others on enforcement procedures and processes.
• Works on special projects and assignments e.g., help develop plans to improve operations or to address areas of concern.
• Testifies in hearings at SOAH and in district court as the Department’s expert witness when requested by the assigned attorney or when ordered by the court.
• Works with the Department’s attorney to clarify all aspects of a contested case to prepare for hearings.

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: Senior