Lori Woznicki
Manor
Summary
Dynamic leader with extensive experience at the Texas Department of State Health Services, excelling in project management and employee training. Committed to fostering a collaborative environment that enhances performance and drives organizational success. Strong focus on team collaboration, operational efficiency, and achieving measurable outcomes. Known for adaptability and consistently meeting changing organizational needs. Poised to contribute to team success and achieve positive results. Ready to tackle new challenges and advance organizational objectives with dedication and enthusiasm.
Overview
32
32
years of professional experience
1
1
Certification
Work History
Food and Drug Unit Director
Texas Department of State Health Services
04.2014 - Current
- Directs the management, coordination, and oversight of the statewide food and drug unit, which consists of the manufactured food program, drug, and medical device program.
- Ensures the food and drug inspections unit implements and adheres to the most current policies and processes put forth by HHSC and DSHS.
- Collaborate with inspection managers and program groups to ensure programs are performing in an effective and efficient manner.
- Evaluate and provide input to rule and policy updates. Works across programs, units, and groups to identify and resolve risks/issues.
- Communicates with other programs concerning high-profile situations.
- Provide guidance and direction to the inspection branch managers and program staff on policy, planning, priorities, and operations.
- Provides project management and direction on key projects and leadership of unit-wide workgroups.
- Provides program-specific information and advice to Associate Commissioner, Commissioner, and Section Directors regarding high-profile topics such as raw milk, drugs/medical devices, and consumable hemp products.
- Ensures the regulations and standards established by the department are fair, equitable, and consistent with state and federal law.
- Develop partnerships with internal and external stakeholders.
- Foster and maintain relationships with other state offices and federal counterparts to keep up with current trends, changes, or concerns with regulations and stakeholders.
- Monitors ordering of supplies and staff travel to ensure the program uses the most cost-effective means available.
- Ensures assignments and deliverables are accurate, and complete and deadlines are met for the unit. Interprets and applies state and federal statutes, regulations, and standards.
- Responds to requests by legislators and other public officials.
- Supports managers working across programs to provide the best customer service to our stakeholders.
- Provide technical assistance to individual licensees.
- Responsible for hiring and selection, assigning work, completing performance evaluations, approving personnel disciplinary actions and scheduling, and approving leave.
- Represents the department by making presentations, providing information and testimony, and collaborating with consumer advocacy associations, other state agencies, and federal partners.
Internship
Texas Department of State Health Services
06.2012 - 04.2013
- Internship for graduate school involved work within the Emerging & Acute Infectious Disease Branch.
- Experienced foodborne illness epidemiologist job duties.
- Worked with real data collected from field interviews from foodborne illnesses.
- Analyzed the foodborne illness data collected from field interviews.
- Compared Texas data with national FoodNet survey data.
- Supplemented data for the Texas population survey for food exposures database.
- Familiarization with the different food history questionnaires.
- Entered data accurately into specified tables.
- Created situation reports from data in questionnaires.
- Analyzed data extracted from questionnaires.
- Compared sets of data to establish prevalence and significance.
- Listened to Center for Disease Control and FDA state conference calls concerning outbreaks.
- Contributed data to the Texas Population Survey for Food Exposure Database.
- Performed statistical analysis of data from the Texas population and FoodNet data.
Drugs and Medical Devices Manager
Texas Department of State Health Services
07.2008 - 04.2015
- Managed and motivated employees to be productive and engaged in work.
- Supervised eighteen drug and medical device investigators, based regionally throughout Texas.
- Accomplished multiple tasks within established timeframes.
- Maintained professional, organized, and safe environment for employees.
- Developed the annual work plan for the group, using risk assessment and risk management criteria and based upon priorities established by the Section.
- Planned, trained, developed, and assigned the activities of the drug and medical device inspection staff.
- Created and standardized the training curriculum for drugs and medical device investigators.
- Authorized sampling and detention activities when staff was conducting inspections.
- Communicated and explained complex laws and regulations to various audiences.
- Ensured inspections were assigned and completed in a timely and efficient manner according to current policy.
- Able to prioritize, assign, monitor, and complete assignments.
- Ensured staff follow agency policies, procedures, and universal expectations.
- Encouraged group learning, communication, and development with DMDG staff.
- Developed performance standards, policies, and procedures for inspection staff and evaluated staff performance throughout the year.
- Hired, counseled, disciplined, and termination of drugs and medical devices staff.
- Provided technical guidance to employees, other branches, units, and executive leadership.
- Ensured the staff meet the federal requirements for conducting contract and partnership inspections and overall development goals.
- Actively participated in ongoing training for disaster preparedness and was the Staff Logistics Deputy Chief when the State Medical Operations Center was activated.
- Coordinated complex investigations involving multiple regulatory agencies at the state level and the federal level.
- Coordinated investigations involving the Environmental Branch and the Radiation Branch.
- Communicated information and investigations with the Food and Drug Administration, Office of Criminal Investigations, Federal Bureau of Investigations, Drug Enforcement Agency, Texas Medical Board, Texas State Board of Pharmacy, Texas Attorney General’s Office Medicaid Fraud Investigators, and other Units within the Division for Regulatory Services and other Divisions within DSHS.
- Reviewed and approves all state license applications applicable to the Drugs and Medical Devices Group, which averages about 6,500 applications a year.
- Determined the violations of the Texas Administrative Code and the Food, Drug, and Cosmetic Act and participates in enforcement hearings.
Environmental Specialist III
Texas Department of State Health Services
01.2004 - 06.2008
- Conducted regulatory inspections of prescription drugs, over-the-counter drugs, prescription medical device manufacturers and distributors, and salvage firms.
- Performed tattoo and body piercing inspections bore the reorganization to DSHS.
- Collected documents and evidence of violations of state and federal regulations observed during routine and complaint investigations.
- Prepared written reports of special investigations and routine inspections for endorsement by the policy, standards, and quality assurance group.
- Communicated and provided guidance to the regulated community concerning changes in state regulations.
- Planned and conducted Food and Drug Administration partnership inspections and prepare written technical reports concerning the findings of the inspection.
- Monitored follow-up actions in cases where violations were found and reviewed compliance monitoring reports.
- Investigated complaints and suspected violations regarding the introduction of illegal prescription drugs or medical devices into the legitimate supply chain.
- Collaborated with other state and federal agencies to exchange information and coordinate activities.
- Coordinated and responded to inspections because of a disastrous occurrence.
- Determined the violations of the Texas Administration Code and Texas Food, Drug, and Cosmetic Act, and issued written notices of violation; participated in enforcement hearings.
- Examined licenses, applications, and records to ensure compliance with licensing requirements.
- Identified products to be sampled as evidence of the violations and followed the proper chain of custody for the collected samples.
- Demonstrated knowledge of State and Federal Laws pertaining to the manufacturing, distribution, salvaging, and labeling of drugs, medical devices, and cosmetics.
- Trained and developed a work plan for new investigators to conduct field inspections of regulated businesses and complaint investigations.
- Cross-trained investigators from various state agencies, both external and internal to DSHS, on how to conduct an inspection at businesses licensed with our agency.
- Coordinated and conducted investigations with various Federal and State agencies (Food and Drug Administration, Office of Criminal Investigations, Federal Bureau of Investigations, Drug Enforcement Agency, Texas Medical Board, Texas State Board of Pharmacy, Texas Attorney General’s Office Medicaid Fraud Investigators, Office of Inspector General, Department of Justice).
- Presented to Medicaid Fraud Task Force Investigators with the Attorney General’s Office concerning the regulatory role of drugs and medical devices and how we can assist them with their investigations.
- Conducted health search warrant when inspections were refused at a licensed entity.
- Assisted with litigation and legal action concerning diverted prescription drug products.
- Home-based position in Houston and worked with minimal supervision.
District Manager
National Health Administrators
09.2001 - 09.2004
- Supervised various locations, enforcing high-quality standards of operation.
- Collaborated closely with other district managers to share best practices, learnings, and drive overall success of the organization.
- Improved team performance by providing regular coaching, training, and mentoring to sales representatives.
- Developed and maintained a database with records of policy sales and active and prospective clients.
- Customized insurance programs to suit individual customers, often covering a variety of risks.
- Calculated premiums and established payment methods.
- Presented long-term insurance plans, endorsed by national organizations, at state-wide conventions.
- Sought out new clients and developed clientele by networking to find new customers.
- Explained features, advantages, and disadvantages of various policies to promote the sale of insurance plans.
- Designed presentations to current and prospective clients.
- Developed marketing strategies to compete with other companies selling insurance.
- Provided direction and leadership to new agents concerning policies, selling techniques, and company protocol.
- Presented at multiple community centers the benefits of Long-Term Care Insurance.
Sales Consultant
Dell Computer Corporation
08.1999 - 07.2001
- Advised clients on appropriate product selections based on their unique needs, ensuring optimal satisfaction levels upon purchase.
- Used consultative sales techniques to understand customer needs and recommend relevant products and services.
- Facilitated and presented materials in staff meetings to team members.
- Participated in team training programs.
- Presented new concepts to team members.
- Contributed to special programs implemented at Dell Computer Corporation.
- Leader for the Mentor Program for new hires.
- Collaborated effectively with various individuals, groups, and organizations to reach sales goals.
- Provided consultative services to clients interested in purchasing a computer.
- Educated clients about the technical components of a personal computer.
- Worked high volume inbound call center sales, processed orders, and corrected billing errors for PC orders.
- Instructed customers on the different computer components and taught them various microcomputer terms.
- Evaluated needs/ benefits and managed financial details in an automated data processing environment and completed sales.
- Consulted with customers to troubleshoot and provide technical assistance for their new PC purchase.
- Used Windows 2000 and Windows 98/ME to assist customers in setting up their new PCs at home.
- Translated technical, complex, or jargon-based information into lay language for customers.
- Exercised balanced judgment in evaluating situations and making decisions.
- Awarded Customer Service Superstar Oct 2000,
- Awarded Customer Experience Superstar Jan 2000,
- Awarded Team Player Oct 1999,
- Awarded Dell Team Player Award, May 2000,
- Awarded Customer Experience Award, January 2001.
Head Waitress
Pappadeaux's Seafood Kitchen
01.1996 - 09.1999
- Supervised server staff and simultaneously served personal section of tables.
- Developed strong relationships with regular customers, fostering loyalty to the establishment.
- Trained new staff members on restaurant policies, procedures, and customer service standards.
- Upheld high standards of professionalism when dealing with customer issues, supporting serving staff, and waiting on tables.
- Provided support to wait staff during the shift.
- Served customers food and beverages at a high-volume restaurant.
- Trained new wait staff.
- Consulted with management about training needs.
- Collected all money and credit card receipts from wait staff at the end of each shift.
- Reconciled all cash and credit card receipts with the final store sales numbers at the end of the shift.
Seventh Grade Teacher
Angleton Independent School District
08.1993 - 12.1995
- Evaluated student progress regularly using assessments, adjusting teaching strategies to optimize learning outcomes.
- Mentored new teachers by sharing best practices and offering guidance on effective teaching methods within our school community.
- Participated in professional development opportunities, continuously improving instructional techniques to stay current with educational trends.
- Instructed seventh-grade students in science and evaluated the lab-based experiments.
- Instructed 6th, 7th, and 8th-grade students in TAAS Math program and Science.
- Provided direction to the students using a computer-based math tutorial system.
- Researched, analyzed, and implemented lab-based activities for the Science program.
- Campus representative for the Calendar Committee.
- Worked with groups to plan and develop strategies for a federally funded tutorial program.
- Established and coordinated the first pep squad at the middle school campus.
- Regularly attended weekend workshops for new, creative project ideas to present to students and teachers.
- Developed educational materials used in the classroom for laboratory experiments.
- Participated on Saturday and evening tutorial sessions sponsored by the school district for kindergartners to high school students.
- Consulted with faculty and parents with written and verbal communication about the progress of all students.
- Maintained a written academic and behavioral log on all students in the classroom.
- Spoke publicly regarding public health issues and educational programs.
- Adhered to policies and procedures pertaining to confidential documents and information.
Education
Master of Public Health - Environmental Health
Texas A&M University
College Station, TX05-2013
Bachelor of Science - Biology
Texas State University
San Marcos, TX12-1997
Bachelor of Arts - Geography
Stephen F. Austin State University
Nacogdoches, TX12-1992
Skills
- Project management
- Regulatory compliance
- Employee training
- Conflict resolution
- Strategic planning
- Performance metrics
- Time management
- Staff development
Certification
- U.S. Food and Drug Administration Commission, expires 10/25/2028
- Texas Teacher Certificate, Secondary Education
- Incident Command System training 100 - 400, 700
- Bioterrorism Training Workshop - August 2005
- FDA Basic Drug School - June 2006
Presentations
- Presented at the Association of Food and Drug Officials Annual Education Conference about The Gray Area, Grand Rapids, MI, June 2024.
- Presented at the Western Region Training Conference for the National Biopharmaceutical Security Council and National Association of Drug Diversion Investigators in Las Vegas, NV April 2011.
- Presented at the North Texas Health Care Fraud Working Group, Federal Bureau of Investigations, Dallas, TX. March 2011.
- Presented at the Annual Education Conference for the Central Texas Environmental Health Association, San Marcos, TX. October 2010.
- Presented at the Texas State Teachers Association concerning the Long-Term Care Insurance Plan endorsed by the National Education Association, Austin, TX August 2002.
- Presented at the Texas State Teachers Association concerning the Long-Term Care Insurance Plan endorsed by the National Education Association, Austin, TX August 2002.
Timeline
Food and Drug Unit Director
Texas Department of State Health Services
04.2014 - Current
Internship
Texas Department of State Health Services
06.2012 - 04.2013
Drugs and Medical Devices Manager
Texas Department of State Health Services
07.2008 - 04.2015
Environmental Specialist III
Texas Department of State Health Services
01.2004 - 06.2008
District Manager
National Health Administrators
09.2001 - 09.2004
Sales Consultant
Dell Computer Corporation
08.1999 - 07.2001
Head Waitress
Pappadeaux's Seafood Kitchen
01.1996 - 09.1999
Seventh Grade Teacher
Angleton Independent School District
08.1993 - 12.1995
Master of Public Health - Environmental Health
Texas A&M University
Bachelor of Science - Biology
Texas State University
Bachelor of Arts - Geography
Stephen F. Austin State University
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