Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic

Nicole Shokatz

Food And Drug Administration Safety Officer
Dulles,VA

Summary

Well-established public health and safety specialist offering more than 16 years of expertise. Exceptional experience in safety and compliance inspections. Known for excellent written and oral skills and knowledge in food safety regulations and public health. My work experiences as a Food Safety and Environmental Protection Public Health Professional domestically and internationally has allowed me to educate and protect the public and environment from illness, disease and destruction. Skilled in conducting efficient and effective safety audits. Natural leader works exceptionally well in both independent and team-centered roles.

Overview

4
4
Certifications
6
6
years of post-secondary education
17
17
years of professional experience

Work History

Consumer Safety Officer

FDA
Beijing, China
08.2014 - Current
  • As a Consumer Safety Officer in China, I conduct on- site inspections of Seafood, LACF, Acidified, Preventative Controls (PC) and other food related manufacturing companies that export food to the USA from mainland China. To date in country I have completed over 125 food industry inspections located throughout China
  • I spend time collaborating and working with our Chinese government counterparts in training and relaying the FDA’s goals and policies as they relate to food safety in America. I coordinate and engaged with external partners and conduct public outreach and communications with firm employees and government officials.
  • I use time during inspections as opportunities to educate by social marketing of public health concepts, such as food safety, nutrition and health. I also educate on environmental health issues such as pollution in our food chain due to pesticides and other chemicals.
  • Living overseas has exposed me to many cultures, I have partially learned Mandarin as a foreign language, encountered many different cultural beliefs and viewpoints relating to food safety and many other issues and have been exposed to daily challenges of living in a foreign country
  • I have been a part of the FDA international forum discussions as a speaker and representative for the China office to engage and educate our FDA co-workers state side of what our work entails overseas
  • This position has allowed me to sharpen my skills in oral and written communication. I can express information related to FDA regulations and importance of food safety to individuals or groups effectively, make clear and convincing oral presentations, listens to others questions and concerns and respond accordingly.
  • As part of my position, I am required to write lengthy detailed reports regarding my inspection findings. This required me to use proper English grammar, punctuation, and spelling, communicate information clearly and in an organized manner and produce a final report which includes technical material, that is appropriate for the intended audience.
  • As part of this position, I am required to utilize knowledge that I have gained through formal training and extensive on-the-job experience to perform my job. I work with, understand, and can evaluate technical information related to my job routinely. Part of my job is to also advise our Headquarters office personnel including CFSAN on technical issues and problems that occur in China.

Foreign Food Report Reviewer

FDA
02.2018 - 05.2018
  • Reviewed, classified and decided on final endorsement activities for foreign food inspection reports for overseas offices Consumer Safety Officer and dedicated cadre inspection work.
  • Fill out and provide a Job Aid or Corrections Requested form titled, DFHAFO Report Feedback Form, and sent to the appropriate person.
  • Review OAI inspection reports and add a recommended District Decision in eNSpect.
  • Provide a summary for any EIR endorsed OAI to CFSAN, or any OP15 that resulted in a recommendation for further action.
  • Provided a summary of any updates to enforcement actions that were taken.
  • Completed Monthly Reviewer Accomplishment Reports and submitted to the FHAFIPB1 branch director Acting.

Supervisory Consumer Safety Officer

12.2015 - 02.2016
  • I acted as the Supervisor for a group of 6 inspectors in the China Office while the position was waiting to be filled.
  • I directed the food program operations in the China Office including assigning work to employees, ensuring investigators were documenting issues and achieving compliance related to the FDA policies and regulations for food safety and administrative supervision of employees work products and inspectional reports.
  • As acting supervisor, I used my knowledge of planning and coordination to effectively assign and monitor work activities and projects that were needed in our office.
  • As a manager, I was Influential in motivating others to perform their job duties and adapted my leadership style to a variety of situations and personalities in our office.

Emergency Response Coordinator, Safety Officer

03.2014 - 08.2014
  • I was selected for a 60-day detail and was concurrently offered a second 90-day detail as the Emergency Response Coordinator position in the Minneapolis District office.
  • My daily duties include planning and coordinating any emergency response activities, outbreak activities, injury and illness complaints from consumers, epidemiology and trace back investigations with FDA personnel and state partners as they arise in the district.
  • I was the federal point of contact with firms as well as local state government with regards to RFR submissions, inspectional and sampling findings, recall coordination activities, consumer complaint illness and injury reports and outbreaks, and natural or man-made disasters that occur.
  • I worked with our district director, compliance director and investigational branch director on inspectional technical questions and make suggestions for follow up activities at firm’s after a recall, adverse event during an inspection, an RFR is submitted or an illness outbreak occurs at a firm.
  • Coordinated with the Minnesota Rapid Response Team and the district’s other state emergency response teams on trainings, technical consultations and implementation related to Incident Command Systems.
  • Coordinate with other offices within FDA on emergency response activities and planning follow up activities including CORE, CFSAN, CVM, Office of Operations, Import Operations, DFFOI and others as needed.
  • I provided trainings for State Liaison job duties and covered for and performed the duties of the State Liaison in our district when the full-time employee was unavailable.
  • My duties included reading and endorsing state contracted inspection reports and being the point of contact for state personnel when questions or issues came up.
  • Administration Consumer, GS-12 Journeymen Level 40 hours/week January 4, 2009 to 2014: Food & Drug.
  • Plan and conduct technical, complex and in-depth inspections of a variety of food facilities as directed or assigned, including Seafood, Juice, LACF, Acidified, BSE, ITP, GMP inspections and Cheese processors.
  • Plan, coordinate and conduct and lead environmental swabbing assignments for the presence of potentially harmful pathogens in food processing facilities.
  • Participate in team inspections when needed relating to emergency food safety situations that need to be dealt with in a timely manner to protect public health.
  • Utilize my experience and knowledge to develop appropriate approaches to inspections and investigations, as well as referencing written programs, guidance’s and regulations.
  • Attend specialized food training courses for more complex areas of the food industry.
  • To date I have successfully completed Juice HACCP,LACF Seafood HACCP, Interstate Travel Program, FDA Food Code and the Food Core I courses.
  • Collect and prepare domestic and import samples as needed for surveillance or for cause situations.
  • Train new hire employees on inspectional techniques and objectives, administrative activities and the regulations for the food programs.
  • Investigate and follow up on consumer complaints regarding illness or injury or tampering of FDA regulated products.
  • Follow up on reportable food registry submissions made by industry.
  • Follow up and help coordinate recall activities for foods or drugs that have been deemed to be unsafe to the public.
  • Work with firms to supply necessary data related to product recalls and supply the information to our district to help facilitate unsafe products being removed from commerce.
  • Participate in seizure and injunction activities as needed.
  • Communicate with industry on any objectionable observations noted during an inspection and the corrective actions they plan to take.
  • Prepare evidence and documentation to support action on a firm that has been found in violations of the FD & C Act.
  • Prepare written reports of the information collected and observations noted during inspections and investigations and make recommendations on regulatory actions.
  • Often step in as the Acting SCSO for my supervisor when she is out of the office.
  • I conduct the supervisory activities for our group of 8 CSO’s including review and endorsing reports, assigning work and working with investigators and compliance on inspection classifications and regulatory actions.

Consumer Safety Officer

FDA
Milwaukee, WI
01.2009 - 08.2014
  • Plan and conduct technical, complex and in-depth inspections of a variety of food facilities as directed or assigned, including Seafood, Juice, LACF, Acidified, BSE, ITP, GMP inspections and Cheese processors
  • Plan, coordinate and conduct and lead environmental swabbing assignments for the presence of potentially harmful pathogens in food processing facilities
  • Participate in team inspections when needed relating to emergency food safety situations that need to be dealt with in a timely manner to protect public health
  • Train new hire employees on inspection techniques and objectives, administrative activities and the regulations for the food programs.
  • Investigate and follow up on consumer complaints regarding illness or injury or tampering of FDA regulated products.
  • Prepare evidence and documentation to support action on a firm that has been found in violations of the FD & C Act
  • Prepare written reports of the information collected and observations noted during inspections and investigations and make recommendations on regulatory actions
  • Acting SCSO for my supervisor when she is out of the office. I conduct the supervisory activities for our group of 8 CSO’s including review and endorsing reports, assigning work and working with investigators and compliance on inspection classifications and regulatory actions.

City of Milwaukee Environmental Health Specialist

11.2004 - 01.2009
  • Inspect restaurants, schools, grocery stores & gas stations for sanitation and food handling practices.
  • Conduct trace back Investigations related to Food Borne Illness outbreaks.
  • Conduct food Borne Illness investigations & food/stool sample collection as necessary.
  • Citizen complaint investigations and public relations.
  • Educate operators and employees on safe food handling and Wisconsin Food Code issues.
  • Fire inspections.
  • Convenience store safety inspections.
  • Plan review and new restaurant consultation and set up of equipment and ventilation systems.
  • Enforcement of the Wisconsin Food Code, including issuing fees and citations.
  • Issue licenses and inspect temporary events for sanitation and proper food safety practices.
  • Conducted pre-inspections of new facilities and issued licenses for new operators.
  • Conduct price verification and package weighing duties (weights and measures).
  • Occasionally worked on writing procedures when requested by my supervisor.

Education

Bachelor of Science - Biology and Environmental Conservation

UW Milwaukee
08.1993 - 01.2000

Skills

    Food Safety Expert

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Certification

• Level I FDA Investigator Certification

Timeline

Foreign Food Report Reviewer

FDA
02.2018 - 05.2018

Supervisory Consumer Safety Officer

12.2015 - 02.2016

Consumer Safety Officer

FDA
08.2014 - Current

Emergency Response Coordinator, Safety Officer

03.2014 - 08.2014

Consumer Safety Officer

FDA
01.2009 - 08.2014

City of Milwaukee Environmental Health Specialist

11.2004 - 01.2009

Bachelor of Science - Biology and Environmental Conservation

UW Milwaukee
08.1993 - 01.2000

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Nicole ShokatzFood And Drug Administration Safety Officer