Detroit, MI 40 hours/week
Supervisor: Rasha Bamieh, (313) 393-8100, contact me first
Consumer Safety Officer, GS-0696-12
Schedule and conduct domestic and foreign investigation/inspection assignments, inspecting regulated products and manufacturers, conducting sample analysis on regulated products, and reviewing imported products offered for entry into the United States.
• Serve as Team Lead for up to four Consumer Safety Officers as needed, assigning tasks, monitoring inspections and acting as Product Center management representative with external federal and state agency partners.
• As senior member of team, provide training and mentorship to new Consumer Safety Officers, providing broad knowledge of FDA inspection procedures and regulations while presenting example-based leadership to motivate employees and promote team excellence.
• Continually stay abreast of emerging food safety issues and changes to regulations. Brief peers and federal/private sector stakeholders, interpreting and outlining significance to daily activities and local environment.
• Perform environmental sampling, including for cause and directed assignments. Conduct field analyses involving weighing, measuring and counting to determine degree of consistency with Good Manufacturing Practices and efficacy of quality controls.
- Consumer Safety Officer at FOOD AND DRUG ADMINISTRATION
11 years, 4 months at this Job
- Bachelor of Science in Microbiology - Food and Drug Law
Alameda, CA 94502
Full Time/40+ hours per week
Consumer Safety Officer(Investigator/Inspector) GS-12/O4
• U.S. representative, on behalf of the FDA to Thailand advising foreign food suppliers and Thailand government officials on new regulations. Conducted four high complexity inspections of high risk food products over three weeks. One resulting in regulatory action and three with voluntary corrections made.
• Certified Senior Investigator responsible for safeguarding the U.S. food network by leading regulatory on-site inspections/assessments of high risk, high complex facilities to ensure compliance with federal regulatory requirements.
• Respond to foodborne illness outbreaks as team lead for national emergencies establishing causative agents and routes of contamination to reduce further public health impact.
• Led four-person Cal-FERT (California Food Emergency Response Team) inspection with California public health officials in response to Canadian Food Inspection Agency (CFIA) finding of contamination of fresh produce and recall of 164,796 cases of product. Insanitary practices were revealed.
• Co-led a three-person outbreak response team investigating Kratom products contaminated with Salmonella linked to 56 illnesses, 44 deaths 25 hospitalizations across 27 states. FDA's first ever administrative mandatory recall issued on all Kratom products, with a court ordered injunction pending. DEA (Drug Enforcement Agency) discussing scheduling Kratom as controlled substance.
• Led three-person environmental sampling team through a cheese manufacturing facility that is a worldwide supplier resulting in a positive Listeria spp sample and a regulatory meeting where company representatives committed to full reconstruction of the areas found to be contaminated, changing their cleaning/sanitation program, increasing the frequency of testing for sanitation, retraining and adding more cleaning personnel.
• Conducted 12 Hazard Analysis and Risk-Based Preventive Controls for Human Food inspections for firms with ≥500 employees and annual revenue of ≥$1 million.
• Co-Led in two covert inspections of laser device manufacturer not in compliance with their laser variance during entertainment show. Audit of laser utilization safety resulted in securing eye safety of 7,000 attendees at the first event and 5,000 attendees at the second event
• Co-lead in an inspection of a noodle manufacturer that resulted in the establishment agreeing to cease operation due to their egregious insanitary conditions (Consent Decree and Warning Letter).
• By request of Deputy District Director, conducted internet surveillance of webpages of one raw camel milk supplier and four dietary supplement firms making false/misleading claims. Resulted in raw camel milk firm cease/desist operation, one warning letter and claims removed from all webpages.
• Review and analyze laboratory programs and public health laboratory tests used to verify proper implementation of environmental monitoring safety programs
• Established appropriate corrective actions to deviations that negatively impact public health and serve as the principal advisor to compliance officers on executing appropriate regulatory action.
• Analyze collected data and findings from investigations/inspections and interpret complex legislative, regulatory, and/or policy guidance for use in prioritizing risk based public health programs.
• Conduct oral briefings, opening/closeout meetings of inspections to forge relationships with regulatory bodies and private industry to facilitate the development and integration of public health program initiatives and activities such as the Food Safety Modernization Act.
• Generate written confidential reports that are clear, factual and grammatically correct accompanied by supporting evidence obtained to convey my inspectional findings.
• Organize, review, and process multiple comprehensive inspections/investigations to ensure the Office of Global Regulatory Operations and Policy's workplan is achieved throughout the Pacific region and globally.
- Consumer Safety Officer(Investigator/Inspector) at U.S. Food and Drug Administration (FDA)
- Lieutenant at USPHS Commissioned Corps
- Lead Medical Technologist (Generalist) / GS-09/O2 at Clarence Wesley Health Clinic
- Medical Technologist II (Microbiology, Serology, Chemistry) at Mayo Clinic of Jacksonville
3 years, 5 months at this Job
- Master's in Public Health - Public Health Practice
- Bachelor of Science - Medical Technology
• Drafts proposals and makes recommendations for new guidance documents that affect regulatory activities, utilizing knowledge of the Tobacco Control Act, the Federal Food, Drug, and Cosmetic Act, and related statutes enforced by the FDA.
• Reviews petitions raising issues that affect a segment of the regulated industry as well as those that pertain to the marketing status of individual products.
• Assists in developing presentations at conferences and professional meetings before the regulated industry, Clinical Investigators, and the medical/scientific community.
• Reviews, summarizes, and provides input to draft responses to public comments received on proposed regulations.
• Knowledgeable of laws and regulations pertaining to Pharmaceutical, Tobacco, and Consumer Products.
• Present oral briefings to office management and peers at dross-organizational meetings.
• Update supervisor on project and analysis progress and findings.
• Participate in client relationship meetings and verbally provide updates on analysis findings to clients.
- Consumer Safety Officer at Food and Drug Administration, Center for Tobacco Products
- Regulatory Counsel at Food and Drug Administration, Center for Tobacco Products
- Environmental Health Physicist at Army Public Health Command
- SIO, Clinical Information Specialist at Technical Resources International
1 year, 10 months at this Job
- Master of Professional Studies - Biotechnology
- Bachelor of Science degree - Biology
- Associate of Arts degree - General 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, 6 months at this Job
- B.S. in Human Nutrition & Dietetics - Human Nutrition & Dietetics
Perform inspections and investigations related to regulated industry; analyze information and prepare technical reports. Provide training to agency personnel and State partners. Recieved the FDA 2004 Outstanding Service Award.
- Consumer Safety Officer at US Food and Drug Administration
16 years, 11 months at this Job
Responsible for handling the full range of enforcement activities under the Federal Food, Drug and Cosmetic Act and the Public Health Act. The activities include untitled letters, warning letters, seizures, injunctions, citations, prosecutions, import detentions, debarment, administrative detention and order of need for an emergency permits. The cases handled involve several complicating factors such as a wide range of issues; unclear sections of the law; lack of definitive court precedent and hostility or lack of cooperation on the part of the regulated industry.
• Evaluates the adequacy of evidence in inspection reports, reports of analyses and other pertinent records in relation to the law, regulations, policies, established precedent and current science.
• Asks probing and insightful questions of the center's scientific experts to obtain a scientific evaluation of the regulatory action in terms of the burden of proof required for the specific charges.
• Determines whether to concur with or disapprove the recommended action based on the significance of the established violations, the adequacy of the evidence, and Agency/Center policy and priorities, or to pursue an alternative action for achieving compliance.
• Writes coherent and persuasive decision documents laying out the evaluation of the regulatory action to defend the decision.
• Updates Agency data systems such as FACTS, Case Management System and other databases. Ensures that the Agency's administrative record is established.
• Assists the Office of the Chief Counsel (OCC), the Department of Justice, field Compliance Officers and U.S. Attorneys in achieving successful case outcomes. This includes working with Center program offices to obtain experts, preparing and responding to interrogatories, preparing or reviewing documents as necessary, and providing any requested assistance, including at trial.
• Evaluates responses to actions to determine the adequacy of the corrections made by the firm and the appropriate regulatory follow-up. Tracks responses in appropriate databases.
• Evaluates responses to detention or Warning Letters issued by CFSAN or submitted by the districts to determine the adequacy of the corrections made by the firm and the appropriate regulatory follow-up. Tracks responses in appropriate databases.
• Develops enforcement strategies for inclusion in Compliance Programs and assignments in conjunction with program offices.
• Facilitates the submission and successful outcome of cases by ensuring that Compliance Programs and assignments contain comprehensive regulatory guidance incorporating the agreed-upon enforcement strategies for the specific areas covered.
• Recognizes emerging problems by utilizing qualitative and quantitative data analysis or other jnformation and develops effective and efficient solutions that have industry or country-wide impact.
• Develops innovative compliance strategies for reducing public health risks associated with volative products in coordination with the CFSAN program offices and the Center's Emergency Coordination and Response Staff.
• Consults with appropriate CFSAN program offices or other references to provide consistent and timely responses to inquiries from the Office of Regulatory Affairs (ORA) and other Center and Agency units.
• Provides timely responses to inquiries related to enforcement issues from Congress, the Department of Health and Human Services, other state and federal agencies and industry.
• Develops criteria for delegating authority for direct reference of cases to ORA. Evaluates direct reference actions to assure they are consistently applied across the field offices.
• Serves on Center or Agency work groups that are considering changes to existing or new regulations, policy or procedures. Work group recommendations are submitted to senior Center or Agency management.
• Participates in the development of formal and informal agency training programs and conferences concerning compliance activities, policy, programs and procedures. Attends and participates in seminars or conferences sponsored by professional industry associations, federal and state agencies.
• Represents Center in meetings with other FDA units, other federal agencies (DHS, USD~US Customs and Border Patrol, EP A, CDC, FI'C, etc.), state agencies, foreign governments, and regulated industry to deal with compliance issues. Participates in meetings with other CFSAN and FDA units concerning policy issues and enforcement strategies.
• Knowledge of the principles, theories, practices and procedures of biological sciences, chemistry, food science, nutrition and/or epidemiological science as they relate to food and cosmetic regulation.
• Sufficient knowledge of FDA laws, regulations, legal precedents, policies and guidelines as applied to foods and cosmetics. Sufficient knowledge of Agency procedural manuals, such as the Investigations Operations Manual, Regulatory Procedures Manual and Compliance Program Manual.
• Some skill in applying regulatory and scientific knowledge in evaluation and "preparation of regulatory actions and related documents. Some skill in planning and implementing complex enforcement strategies that require input and cooperation from diverse groups.
- Consumer Safety Officer at U.S. Food and Drug Administration
- Compliance Officer at U.S. Consumer Product Safety Commission
- Public Health Analyst at Health Resources and Services Administration (HRSA)
- Environmental Compliance Specialist I, II & III at Northwest Georgia District Board of Health
3 years, 5 months at this Job
- Master of Health Services Administration
- Bachelor of Science - Health Science
- Master - Public Health
2009 Bachelor of Multidisciplinary Studies
• Specialization in: Business, Communications, and Food Science Team Work Advanced Self Motivation Next Level
- Consumer Safety Officer at West Virginia University
- at State and Federal
15 years, 2 months at this Job
- - Education
Examine imported products and determine the admissibility of FDA regulated products. Conduct online entry reviews, inspections, and field exams. Document evidence and enter results into database. Ensure compliance of imported products with FDA laws and regulations to protect the public health. Professional office environment using Microsoft Office programs.
- Consumer Safety Officer at Food & Drug Administration
- Administrative Assistant at The National Trial Lawyers
- Child Nutrition Program Manager at Fort Rucker Schools
- Quality Control Coordinator at Intermark
4 years, 6 months at this Job
- Bachelor's - Food Science
• Conduct regulatory inspections on drugs, medical devices, and food products.
• Make recommendations and ensure importing firm is compliant with regulatory procedures.
• Apply chemistry, biology, and pharmacology knowledge to review detained medical devices and pharmaceuticals.
• Efficiently manage multiple inspection assignments. Coordinate with brokers, importers and firm managers to meet inspection deadline for timely release of product.
• Coordinate with compliance officers, entry reviewers, and chemists to arrange appropriate regulatory actions on non-compliant firms.
• Analyzed company financial statements and evaluated efficacy of medical devices and pharmaceutical.
- Consumer Safety Officer at Food and Drug Administration
- Pharmacist at CT Health Pharmacy
- Public Health Intern at Department of Health and Mental Hygiene
- Pharmacist at Pathmark Pharmacy
2 years, 2 months at this Job
- Master of Science in Computer Information System - Computer Information System
- Doctor of Pharmacy - Pharmacy
Write recall strategy recall notification letters
• Assess the health hazard of a recall product
• Request additional information about potential and/or ongoing recall situations from industry.
• Verify whether the supporting documents and/or spreadsheets match the information that was submitted to CFSAN
• Knowledge of EPA's regulations on pesticide residue tolerances for food and of EPA's drinking water standards
• Sufficient skill in applying regulatory and scientific knowledge in evaluation and preparation of regulatory actions and related documents
• Skill in planning and/or implementing enforcement strategies that require input and cooperation from diverse groups
- Consumer Safety Officer at U.S. Food Drug Administration
- Independent Food Safety Consultant at Access Quality Management System
- Account Sanitarian at QSI/Swedish Match
- Consumer Safety Officer at U.S. Food and Drug Administration
1 year at this Job
- Bachelors of Natural Science - Biology