•Responsible for enforcing the laws and regulations protecting consumers from food that are impure, unwholesome, ineffective, improperly or deceptively labeled or packaged, or is in some way dangerous.
•Concerned with obtaining voluntary compliance with law and regulations, such as The Food, Drug and Cosmetic Act, and applicable Codified Federal Regulations.
•Identify substances and sources of adulteration and contamination.
•Evaluate raw materials, manufacturing methods and processes, laboratory analyses, packaging and distribution methods, labeling, storage conditions of food manufacturing facilities and conveyance construction facilities.
•Conduct domestic inspections, independently and as a member of a team, of food manufacturing facilities with limited guidance documents, proposed or new regulations must be used, or the inspection may result in public, media, and Congressional review.
•Prepare reports and investigation memoranda for completed inspections.
•Review reports and investigation memoranda for accuracy with prescribed procedures for junior Consumer Safety Officers.
•Provide guidance and consultation regarding inspection methods and procedures to junior Consumer Safety Officers.
•Serve as local focal point and provide authoritative interpretations applicable laws, regulations, and programs of the Interstate Sanitation Program for Human and Animal Food Operations, Division 5 East, Investigations Branch Group 1, which covers four states.
•Plan, organize, and conduct meetings with private industry to exchange information and provide advice and guidance regarding conveyance design, construction, and operation as it pertains to The Food, Drug and Cosmetic Act, and applicable Codified Federal Regulations.
•Gather and compile data using various data collection techniques, to include but not limited to, Peer-Reviewed trade journals.
•Utilize thorough knowledge of agency laws, regulations, policies, and precedents to collect necessary documentation and evidence of violative conditions.
•Evaluate sanitary design of potable water systems, food service areas, passenger convenience areas, and lavatory waste onboard conveyances traveling in interstate commerce.
•Review blue-prints and engineering drawings for the issuance of a Certificate of Sanitary Construction for conveyances that operate in interstate commerce.
•Evaluate sanitary design and function of servicing areas and potable water points listed on the FDA Aircraft Watering Point and Servicing Area Inventory online database.
•Identify and evaluate deficiencies observed in human food manufacturing, packing, warehousing, and distributing facilities.
•Identify and evaluate deficiencies observed in construction phase of aircraft and vessels scheduled to operate in interstate commerce.
•Report on significant inspectional observations made during establishment inspections of human food manufacturing, packing, warehousing, and distributing facilities.
•Report on significant inspectional observations made during inspections of areas where conveyances board potable water, discharge lavatory waste, and receive food items. Supervisor: Krista K. Whitten (615-366-7842 ) Okay to contact this Supervisor: Yes
- Consumer Safety Officer at U.S. Food and Drug Administration
- Air Transportation Specialist at United States Air Force/ Air National Guard
- Wildlife Specialist at United States Department of Agriculture Rural Development
- Wildlife Biologist at Soterra LLC
3 years, 5 months at this Job
- Associate - Business Management and Transportation
- Bachelor's - Wildlife Management
- High school
• Serves as recognized authority in scientific matters related to area of responsibility (Pharmacy Compounding).
• Serves as Lead of a team of Consumer Safety Officers providing direction, instruction and guidance in the review and evaluation of compliance cases in pharmacy compounding.
• Recommend and monitor the progress of regulatory actions against firms for which FDA inspections show egregious violations of applicable regulations and the FD&C Act. Revised: Date - January 2019 1 J. Del Valle Ortiz
• Provides leadership, guidance, and regulatory mastery to address and solve complex regulatory issues consistent with technological developments or new scientific evidence.
• Oversees and directs science based interactions between branches and offices to facilitate robust regulatory decision making.
• Independently analyzes the inquiry and obtains salient facts from technical and legal material available. Draws conclusions based on findings and recommends a specific action, specifying new policy interpretations and/or revised policy.
• Counsels and trains members of the team, personally explains critical and significant theories, principles, concepts, and practices of the discipline.
• Analyzes problems and develops enforcement strategies to address drugs that are adulterated, misbranded, unapproved, or other violations of the FDCA using a scientific and regulatory, risk-based methodology.
• Reports to senior management periodically on team and individual work accomplishments, problems, progress, and needs.
• Prepares comprehensive summaries and integrated discussions of data submitted for review and other available information.
• Participates in the decision-making process related to drug manufacturing facility design evaluation, operations of drug manufacturing facilities, including manufacturing and testing procedures.
• Evaluates and makes authoritative recommendations with respect to compliance with Current Good manufacturing practices (cGMPs) regulations and other applicable requirements and policies and advises on the resolution of pharmaceutical manufacturing and/or drug compliance issues.
• Review cases of multiple inspections related to compounding outsourcing facilities 503B and 503A.
• Analyzes problems and develop solutions such as enforcement actions involving violations of the Federal Food, Drug and Cosmetic Act (FDCA) using a risk- based methodology.
• Present and develop road maps, warning letters and state referral letters related to compounding cases for regulatory action recommendations.
• Participate as subject matter expert in drug inspections related to compounding outsourcing facilities 503B and 503A. Revised: Date - January 2019 2 J. Del Valle Ortiz
• Provides a focal point within FDA to whom all levels of FDA personnel may turn for authoritative guidance and consultation regarding inspection and investigation methods and procedures necessary to accomplish compliance / enforcement / regulatory objectives.
• Participates as a subject matter expert in the onsite evaluation of field activities.
• Identifies areas which warrant further study or improvement and prepares reports to ensure optimum operating efficiency and resource utilization.
• Reviews special and unusual problems submitted by various Center/Offices and provide authoritative guidance to resolve the issues causing the problems - such issues frequently deal with interpretations of law, policy, and procedures.
• Conducts research into legal precedents and legislative history of the Acts enforced by FDA.
• Reviews inspection reports to evaluate data provided to support the identity, strength, quality, and purity of drug substances and new human and animal drug products, as well as specifications and methods of analysis for drug substances and animal drug products.
• Analyze results of experiments to determine whether data generated is accurate and valid.
• Review of inspection reports and supporting documentation to determine if manufactured animal drug products maintain appropriate chemical and microbiological quality attributes throughout marketed shelf-life.
• Prepares position papers for top FDA managers based on such research.
• Gathers information on scientific and regulatory activities and policies that protect animal and human health.
- Lead Consumer Safety Officer/Interdisciplinary at U.S. Food and Drug Administration
- Quality Assurance Specialist III/ Senior Validation at Sigma Aldrich
- Quality and Regulatory Specialist at Canon US LifeSciences
- Quality Assurance Engineer at Imaging Diagnostic Systems, Inc
5 years, 1 month at this Job
- Master of Science in Pharmacy - Pharmaceutical Outcomes and Policy / Clinical
- Bachelor of Science in Industrial Microbiology - Industrial Microbiology
Perform health and safety inspections on businesses and institutions. Conduct food and beverage review to ensure compliance with federal regulations. Check food temperature, handling, and labeling. Maximize employee alignment with HACCP plans and processes. Provide education on public health and sanitation. Offer testimony in court hearings. Refer cases across government agencies. Document and report on inspections and investigations.
- Consumer Safety officer at U.S. Food and Drug Administration
- Retail Specialist at Apple Inc.- Woodfield Mall
- Sales Associate at Ann Taylor
- Customer Service/Sales Associate at Macy's
4 years at this Job
- Master of Public Health - Healthcare Policy & Management
- Bachelor of Science - Biology
Assisted in developing the first ever NJM Teen Driver Safety Program to commemorate the 100th anniversary of NJM. This initiative was offered to New Jersey high schools free of charge. Presentations were conducted with a proprietary Power Point which utilized short text and various videos focusing on topics including seatbelts, compliance of the NJ GDL Law, other traffic laws, distracted driving, drowsy driving, impaired driving, statistical information, pedestrian safety, etc. Over the course of five (5) years, I conducted approximately 1700 presentations to nearly 70,000 students. https://www.njm.com/teen-driver-safety
- CONSUMER SAFETY OFFICER at New Jersey Manufacturers Insurance Company
- LIEUTENANT at NEW JERSEY STATE POLICE
- SERGEANT FIRST CLASS at NEW JERSEY STATE POLICE HIGHWAY TRAFFIC SAFETY UNIT
- SERGEANT at NEW JERSEY STATE POLICE MOTOR VEHICLE RACING CONTROL UNIT
5 years at this Job
- BA - Individualized Studies
• Serve as subject matter experts (SMEs) in food safety programs.
• Train and standardize inspectors at all levels of government on conducting risk-based inspections. (federal, state, local and tribal governments).
• Serve as a technical advisor to industry and regulatory authorities.
• Perform HACCP & GMP based inspections for use in the national FDA Risk Factor Study. Utilize knowledge of regulatory food safety requirements to identify non-compliances, Recommend mitigation, and ensure that effective corrective actions are implemented.
• Represent FDA during committee meetings and consumer protection workgroups.
• Project management of multiple complex projects.
• Support the agency's position with promoting the adoption of and usage of the Voluntary National Retail Food Program Standards and the FDA Model Food Code.
• Assist regulatory agencies to improve their programs.
- FDA Consumer Safety Officer & Retail Food Specialist at US FOOD & DRUG ADMINISTRATION
- Deputy Director, Student Nutrition Bureau, Public Education Department at THE STATE OF NEW MEXICO
- State Food Program Manager at New Mexico Environment Department (NMED) Field Operations Division
- ATSDR Grant Funded Program Public Health Assessor at GILA RIVER INDIAN COMMUNITY
8 years, 4 months at this Job
- B.S. in Human Nutrition & Dietetics - Human Nutrition & Dietetics
Protect and promote public health through the enforcement of laws and regulations protecting consumers from drugs that are dangerous, or defective in the following ways:
• Provide support to Consumer Safety Officers and Regulatory Health Project Managers for the Division of Dermatology and Dental Products
• Maintain control, coordination, and management for review of Investigational New Drug Application (IND), New Drug Application (NDA), and Biological License Application (BLA) submissions in compliance with 21 CFR 312, 21 CFR 314, and 21 CFR 600
• Perform administrative review of Investigational New Drug, New Drug Application, and Biologic License Applications correspondences, supplements, and amendments
• Serve as co-leader of multi-disciplinary teams with a wide range of professional skills in the discipline areas of clinical medicine, chemistry, biostatistics, Biopharmaceutics, pharmacy, clinical microbiology, and pharmacology toxicology
• Develop project plans, including setting time frames, milestones, and agreed upon endpoints in collaboration with multi-disciplinary review team (scientific, regulatory, and management)
• Coordinate and manage multidiscipline review teams for an array of new and ongoing submissions
• Effectively communicate with multidiscipline review team members and management regarding assignments and submissions
• Monitor drug and biologic submissions from initial receipt through the life cycle
• Review and determine that all written reviews of sponsor submissions are present and non-conflicting
• Determine outgoing letters to sponsors are aligned with laws and regulations, ensuring communication is clear and accurate prior to final approval by the Division Director
• Prepare and review information requests, advice, and responses to sponsors for Investigational New Drugs, New Drug Applications, and Biologic License Applications
• Initiate, prepare, and coordinate response to requests for additional information from Congress, industry, and other FDA divisions
• Manage, support, advise, and coordinate an FDA Regulatory Briefings, industry meetings, and other internal meetings as needed
• Assist in logging, prioritizing, and tracking communication to Division of Dermatology and Dental Products staff
• Serve as liaison to internal and external constituents of the FDA
• Provide interpretation of legislation, including Prescription Drug User Fee Act (PDUFA) V
• Provide regulatory advice and guidance to staff in the Division of Dermatology and Dental Products
• Interpret and assess new methods of processing and analysis of submissions
• Track content issues, action items, and reviews and ensure follow-up
• Resolve regulatory and technical issues with submissions
- Acting Consumer Safety Officer (Office Automation Clerk) at Food and Drug Administration, Division of Dermatology and Dental Products
- at AAP Scholarship Recipient
- Learning Partner at Patient Transport
- at Therapeutic Staff Support
7 years, 10 months at this Job
- Bachelor of Science - Economics
- Master of Business Administration
- Master of Science - Biotechnology
• Plan and conduct regulatory inspections and in-depth investigations of various industry establishments; such as warehouses, manufacturers and distributors.
• Perform analyses and evaluation on data samples and documented information gathered during inspections and investigations to ensure that documentation and practices follow Federal laws, rules and regulations.
• Sampled cheese varieties contamination including: Mimolette, Milbenkase/melinkase/Spinnenkasa, Salers, Cabrales, and Surk. These cheeses were targeted as products more susceptible to be affected by mites/maggots.
• Communicated daily with approximately 100 import industry agents regarding queries and provide scientific and technical advice, and use judgment and a good knowledge of agency policies and priorities to set priorities for handling many unscheduled matters.
• Collaborated with Alcohol and Tobacco Tax and Trade Bureau (TTB-TID) to seize a product marketed as soda that was found violative and contained alcohol greater than .5% based on lab analysis from TTB-TID.
• Maintain liaison, plan, and coordinate activities with United States Customs and Border Protection in the field and through the John F. Kennedy International Mail Facility where approximately 10,000 parcels suspected to contain illegal, illicit, unapproved, counterfeit and potentially dangerous drugs and dietary supplements are screened yearly.
- Consumer Safety Officer at Food and Drug Administration
- Detail Supervisory Consumer Safety Officer at Food and Drug Administration
9 years, 6 months at this Job
- Masters of Professional Studies - Environmental Management
- Bachelor of Science - Environmental Health
The job includes, investigating complaints of injury, illness, or death caused by an FDA-regulated product; initiating actions against violators; advising industry, state and local officials and consumers on enforcement policies, methods, and interpretation of regulations; planning and directing regulatory programs; developing inspection procedures and techniques. I have also participated in a unique software program implementation that allows field personnel to conduct inspections and inspection reviews more efficiently.
- Consumer Safety Officer at US FDA
at this Job
- Master's - Education
- Bachelor's - Environmental Science
40 hours per week Starting Salary: 30,000 Ending Salary: $89,800 As a Congressional Correspondence Specialist, I prepared responses to over 100 congressional correspondences from the U.S. senate, congress and White House officials in reference to pre-amended medical devices in U.S. commercial distribution; scientific reviews, medical device recalls and medical device safety alerts, while ensuring the correspondence meet the given deadline. * Coordinated and monitored all congressional correspondences through the review and approval process; analyze congressional legislation; gather materials to facilitate the assessment of the potential impact on medical device radiological health. * Classified and summarized data for the preparation and submissions of congressional responses; present recommendations/solutions; and provide analytical, planning and administrative support in respect to preparing responses to all congressional correspondences. * Developed written communications and content to help inform and educate members of congressional staffers, federal government and state officials on the value of safe and effective of medical device products. * Prepared and produced congressional responses to White House Officials, congressional staff members, regulatory law firms, advocate groups, consultants and academia. * Monitored sources, gathered materials and facilitated the analysis of potential implications of legislation, regulation and government policy with respect to the Food and Drug regulatory law, procedures and regulations. * Supported the preparation and Call for Action on top priority congressional correspondences by maintaining document control, editing, reviewing input, planning and facilitating meetings, taking notes and communicating with work group members. As a Freedom of Information (FOIA) Specialist, I prepared and responded to over 200 FOIA correspondences from medical device manufacturing firms, regulatory consultants, medical device advocate groups, U.S. congress and medical device users and patients. * Prepared FOIA responses to the FOIA requests from congressional staff, consumers, academia, advocate groups and regulatory law firms. * Performed a review of the FOIA correspondence request to determine if the requester reasonably described the records with respect to all pertinent information, details that would identify the records sought according to Sec. 20.24 of CFR Title 27, Volume 1. * Determine the confidentiality that would be held in confidence or that would not be available for public disclosure; and determine the data and information that is being sought by the FOIA requester with respect to it be exempt, such as trade secrets, confidential commercial and financial information according to SEC 20.21 of CFR 27 Volume 1. * Conduct search for the FOIA records, making a reasonable effort for obtaining the information sought or requested in electronic format or format according to SEC 20.24 of CFR Title 27, Volume 1. * Prepared records for routine public distribution, e.g. speeches and educational materials according to Sec 20.23 of CFR Title 27, Volume 1. * Prepare fees to be charged for FOIA requests searches with respect to categories of request and certified and authentic records being sent to the requester, according to Sec 20.3 of CFR 27 Volume 1. responding to various FOIA correspondences from medical device manufacturing firms, regulatory consultants, medical device advocate groups, U.S. congress and medical device users and patients. * Prepared FOIA responses to the FOIA requests from congressional staff, consumers, academia, advocate groups and regulatory law firms. * Performed a review of the FOIA correspondence request to determine if the requester reasonably described the records with respect to all pertinent information, details that would identify the records sought according to Sec. 20.24 of CFR Title 27, Volume 1. * Determined the confidentiality that would be held in confidence or that would not be available for public disclosure; and determine the data and information that is being sought by the FOIA requester with respect to it be exempt, such as trade secrets, confidential commercial and financial information according to SEC 20.21 of CFR 27 Volume 1. * Conduct search for the FOIA records, making a reasonable effort for obtaining the information sought or requested in electronic format or format according to SEC 20.24 of CFR Title 27, Volume 1. * Prepared records for routine public distribution, e.g. speeches and educational materials according to Sec 20.23 of CFR Title 27, Volume 1. * Prepare fees to be charged for FOIA requests searches with respect to categories of request and certified and authentic records being sent to the requester, according to Sec 20.3 of CFR 27 Volume 1. As a professional Customer Service and Government/Private Industry Liaison Specialist, I managed over 300 medical device firms and companies between private industry with respect to information exchange in resolving pending medical device issues for domestic and international medical device telephone conferences, video conferences and panel executive meetings. * Served as a quality assurance representative to ensure the accuracy of in-coming medical device information from device manufacturing firms and regulatory consultant companies. * Contributed to improving customer, stakeholder, and company satisfaction that resulted in positive business relations between private industry and FDA. * Demonstrated leadership with respect to participating in workgroups or teams, such as those that design or influence improvements in program policies. * Established communicated necessary actions to all manufacturing companies, regulatory law firms and Division staff members to ensure customer satisfaction is conveyed. * Establish and maintain strong relationships with all clients; understanding their priorities; balancing their interests with organizational demands and requirements. * Lead in proactive customer responsive manner that consist with the organization's vision and values; ascertains customer needs; solicits feedback; and makes appropriate adjustments. As a Project Management Specialist, I performed special literature scientific device literature research projects, I performed the following duties: * Conducted a literature search on medical device scientific articles using library resources such as PubMed. * Provided a summary of the abstract of the literature article with the significant results. * Produced an excel worksheet of all literature articles summarized for review. As a Scientific and Medical Writer, I wrote over 300 technical medical device scientific reports that consisted of executive meeting minutes of record; medical device classifications and recommendations and scientific medical device reviews for the Division of Anesthesiology, General Hospital, Infection Control and Dental Devices (DAGID). * Managed medical device manufacturing company/firms confidential scientific medical device submissions by maintaining all confidential information in a filing system keeping abreast of all records of submissions information with respect to scientific data, research and testing. * Prepare annual and quarterly reports on excel spreadsheet for division and scientific staff with respect to standards groups, committees and working groups. Honors and Awards 20- year Service Government Certificate, 2010 10- year Service Government Certificate, 1999 CDRH Group Recognition Award, 1985 Professional Associations/ Affiliations
- Consumer Safety Officer at Department of Health and Human Resources (DHHS)
- at Beta Club
- at Knights and Ladies Honor Society
19 years, 1 month at this Job
- High School Diploma - Watson Chapel
- Bachelor of Science - Science
Performed establishment inspections, investigations, sample collections to ensure the food, drug, and cosmetics act was being followed and all appropriate CFR Regulations, GMP's, SSOP's, and HACCP plans were being followed by the facilities within the food and feed division of FDA-ORA. Preformed inspections on food, egg, feed, seafood, BSE, medicated feed, and feed 507 GMP inspections with regulatory and compliance actions. Promoted to GS-12 Journeyman Level on 05/15/2018.
- Investigator / Consumer Safety Officer at Federal FDA
- Certified Federal Food Inspector at Federal USDA Dept. of Ag
- Certified Agricultural Inspector at USDA, Georgia Dept. Of Ag
- Certified Substitute Teacher at Jackson County School System
4 years, 1 month at this Job
- - B.S.A. Poultry Science
- A.S. - Poultry Science