INSPECTION SPECIALIST - 79011486

State of Florida • Fort Lauderdale, FL

3d

About The Position

The Division of Drugs, Devices, and Cosmetics (DDC) regulates under the provisions of the Florida Drug and Cosmetic Act (Chapter 499, F.S.) by licensing, registering, inspecting, and investigating the manufacture, distribution, and sale of drugs, medical gases, and cosmetics in the State of Florida. This position will be responsible for enforcing Chapter 499, Florida Statutes, and Rule Chapter 61N-1, Florida Administrative Code, through inspections and investigative actions.

Requirements

• Knowledge of principles, practices, standards, and terminology of pharmacy and related manufacturing and distribution industries.
• Ability to evaluate pharmacy methods, procedures, and services.
• Knowledge of drug types, contents, and properties.
• Knowledge of Florida and federal laws and regulations for drugs, devices, and cosmetics, including, without limitation, as regards state and federal good manufacturing practices, supply chain integrity, and import/export of drugs, devices, and cosmetics.
• The ability to communicate clearly, effectively, and professionally, both verbally and in writing, is essential.
• Skills in using computer programs for the department, including Microsoft Office software required.
• Ability to plan, organize, and coordinate work assignments.
• Ability to multitask.
• Ability to maintain strict confidentiality.
• Ability to train others.
• Ability to manage a significant workload and meet performance goals with minimal day-to-day oversight.
• Ability to develop and maintain a perpetual inventory control system.
• Ability to utilize problem-solving techniques and to establish and maintain effective working relationships with others.
• Flexibility and ability to meet deadlines on short notice.
• High school diploma or certificate of high school equivalency; and
• A valid driver’s license.

Nice To Haves

• A diverse pharmacy practice background and/or investigative experience with a government agency directly related to state or federal drug laws.
• Experience conducting investigations and/or audits.
• Significant responsibility for regulatory compliance at a prescription drug manufacturer, wholesale distributor, hospital system, or chain pharmacy warehouse.
• Excellent writing skills.
• Experience with administrative law.

Responsibilities

• Inspects, monitors, and investigates persons and establishments subject to Chapter 499, F.S., including applicants for permits compliance with Florida law.
• Investigates violations of Chapter 499, F.S., and Rule Chapter 61N-1, F.A.C., as well as federal statutes, rules, regulations, and other laws concerning drugs, devices, and cosmetics.
• Gathers and analyzes evidence and prepares and submits technical and operational documents related to inspections and investigations, including inspection and investigation reports, complaints, notices of inspection results, and warning letters, all within specified time limits.
• Serves as a statewide subject matter expert.
• Provides consultation and technical assistance in matters relating to compliance with Chapter 499, F.S., and Rule Chapter 61N-1, F.A.C., as well as federal statutes, rules, regulations, and other laws concerning drugs, devices, and cosmetics.
• Participates as assigned in training personnel concerning best inspection/investigative practices and procedures.
• Assists in developing and training other department personnel regarding the DDC’s operational tools, including equipment, hardware, and software used in performing assigned duties.
• Advises the Pharmaceutical Program Manager and the Chief of Compliance and Enforcement on policies, procedures, and training.
• Educates the regulated industry about compliance with Chapter 499, F.S., and Rule Chapter 61N-1, F.A.C., as well as federal statutes, rules, regulations, and other laws concerning drugs, devices, and cosmetics.
• Advises, interfaces with, and coordinates with federal, state, and local law enforcement and regulatory agencies and authorities, including, as assigned, interagency task forces.
• Represents the DDC as a recognized source of expertise and authority in conferences, meetings, and presentations involving issues of considerable importance.
• Provides testimony at trials, hearings, depositions, and proceedings concerning matters within the scope of the described duties, including inspections, investigations, chain of custody, and records. May be required to provide testimony as a designated records custodian for purposes of authenticating department records.
• Performs other related duties as assigned, including assisting as needed in responding to and recovering from natural or manmade disasters or other emergencies.

Benefits

• State of Florida retirement package: 3% employee contribution required.
• Nine annual paid holidays and one personal holiday.
• Ability to earn up to 104 hours of paid annual leave annually as a new employee with the State of Florida.
• Ability to earn up to 104 hours of paid sick leave annually.
• The State of Florida offers health insurance coverage (i.e., individual and family coverage) to eligible employees.
• The State of Florida provides a $25,000 life insurance policy to eligible employees.
• Additional supplemental insurance policies are available for dental, vision, hospital supplements, cancer, etc.
• Tax-deferred medical and childcare reimbursement accounts are available.
• Tuition waiver program to attend an approved State of Florida College or University.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED