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Consumer Safety Officer Resume Samples
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Candidate Info
9
years in workforce
3
years at this job
PhD
Human Nutrition
Consumer Safety Officer
Protected the public health by ensuring the safety and/or effectiveness of both imported and domestic food, drugs, cosmetics, and medical devices
- Planned and conducted regulatory inspections and in-depth investigations of medical device and food facilities
- Analyzed and evaluated data samples and documented information gathered during inspections and investigations
- Prepared concise factual reports reflecting significant observations upon completion of assignments
- Provided basic training to lower grade inspectors and support personnel in the areas of import operations, establishment inspections, and special investigations
Candidate Info
4
years in workforce
4
years at this job
BS
Public Health
Consumer Safety Officer, Investigator
Independently planned, coordinated, and conducted technical inspections/audits and in-depth investigations in areas of Class II medical devices, drugs, bioresearch monitoring (drugs & devices clinical trials), and radiological health as it related to review of CAPAs, Design Controls, Process and Production, Management Reviews, complaint systems, RMAs, Document Controls, Purchasing Control, 510(k), etc. to ensure regulatory compliance
- Prepared concise, factual final reports, memoranda, and other written documentation that supported investigative findings and recommendations
- Made recommendations to district management officials as to whether or not a firm involved in production, control and testing of FDA regulated products are in compliance regarding cGMP issues
- Independently performed investigations involving complaints of tampering, injury, or death attributable to products regulated by the FDA and discussed findings with OCI or other FDA officials
- Provided on-the-job training to newer employees with techniques employed in establishment inspections, sample collections (including documentary samples), affidavits, and investigations
- Responded to a variety of inquiries from industry and consumers involving products regulated by the FD&C Act
- Assisted the Public Affairs Specialist with community health fairs by attending, setting up, and participating in/presenting information at health fairs
- Maintained districts medical device registration database in FACTS, OSCAR, TurboEIR, Titan/QWS3270 Plus(X-Rayapsy), and Maude
Candidate Info
2
years in workforce
1
year at this job
BS
Biology
Chemical Engineering
Consumer Safety Officer
Independently planned and conducted regulatory inspections.
- Evaluated data samples and documented information during investigations to ensure all practices were in compliance with Federal laws.
- Prepared reports and made recommendations to manufacturers under investigative review.
- Diagnosed and advised networking infrastructures.
- Responsible for outside sales campaign.
- Followed up with client problems and issues.
Candidate Info
7
years in workforce
7
years at this job
BA
Biology
Consumer Safety Officer
Assessed and evaluated sensitive information.
- Researched, analyzed, and evaluated information provided to determine appropriate action
- Answered inquiries from other Federal, State and local agencies, industry, importers regarding FDA requirements and regulations.
- Established and maintained collaborative relationships with field personnel, both FDA and US Homeland Security.
- Provided technical expertise to industry representatives, US Customs and other Agencies.
- Performed a wide variety of Domestic Inspections, investigations, audits and assessments FDA regulated products.
Candidate Info
58
years in workforce
5
years at this job
BS
Health Administration
Supervisory Consumer Safety Officer
Directed regulatory work across a number of programs including biologics, clinical research, and drugs.
- Established guidelines and performance expectations for staff.
- Observed staff performance and conducted work performance critiques.
- Developed work improvement plans and recommended personnel actions as necessary.
- Assured subordinates were trained and fully comply with the provisions of safety regulations.
Candidate Info
4
years in workforce
4
years at this job
C
Certificate
AS
Science
BS
Environmental Health Science
Consumer Safety Officer
- Collected water and air samples, analyzed data, and recommended legal action to Section Chief.
- Inspected pesticide-producing plants, and wrote summary reports.
- Reviewed state programs and submitted proposals for improvements to Section Chief.
- Coordinated the dissemination of regulatory information from EPA, Washington, to the Atlanta office and state governmental agencies.
- Negotiated settlements with and coordinated fee collection from companies in violation of federal law within EPA’s sectional timeframe.
- Tracked case progress and maintained record-keeping system of EPA-granted state special permits.
- Increased public awareness of the toxicity of pesticides by speaking engagements to community groups.
- Trained state inspectors on EPA regulatory procedures, resulting in higher safety to pesticide users.
- Conducted thorough research for EPA on product safety and wrote monthly reports on health and safety issues related to EPA cases.
Candidate Info
1
year in workforce
1
year at this job
BS
Horticulture
Consumer Safety Officer
Review and evaluate promotional materials to ensure they comply with all Federal laws and regulations.
- Monitor production activities for food and prescription drug products to ensure industries are comply with all Federal laws and regulations.
- Initiate reports and FDA 483 to document any violation identified during the inspection as well as recommendations for regulatory actions.
- Investigate complaints of injury, illness, or death caused by a product regulated by the FDA
Candidate Info
9
years in workforce
6
years at this job
BA
Biological Sciences
Liberal Arts
Biology
Consumer Safety Officer
Communicates information about the laws and policies of the FDA to consumers, industry, and related government agencies in the interest of the promotion of public health.
- Independently and/or jointly audits, reviews, and evaluates the manufacturing processes of products that the FDA regulates by inspecting manufacturing facilities.
- Collects samples of FDA products for laboratory testing or as evidence in FDA related cases.
- Assure efficient enforcement of the FD&C Act.
- Investigates complaints of violations of FDA's laws, injuries to consumers and illnesses involving FDA regulated products.
- Prepare detailed reports of each investigation.
Candidate Info
17
years in workforce
5
years at this job
BS
Chemistry
Food Processing & Technology
Consumer Safety Officer / Investigator
Inspections - Inspect a variety of regulated firms to ensure compliance to Food Drug & Cosmetic act, document, and report deviations where applicable. Specialize in food manufacturing.
- Consumer Complaints - Conduct interviews and follow-up communications on reported complaints from consumers that may or may not have incurred physical injury as a result of consuming a suspected product.
- Recall Audit Checks - Follow up on firms' reported recall process following a recall of products from the market place.
- Sampling - Collect samples for both routine surveillance and supporting evidence in violative cases.
Candidate Info
4
years in workforce
1
year at this job
AS
Associate of Science
AS
Biology
BA
Bachelor of Arts
Consumer Safety Officer
Review and evaluate evidence for legal and administrative actions, recalls and pre-market approval clearance for medical devices and/or radiological products.
- Issuing permits for food establishments.
- Skilled with automated field inspection and equipment.
- Review & respond to a variety of inquiries involving the FD&C Act and enforces state and county regulations.
- Provides consultation and education to managers and employees of food service establishments.
- Interprets questions regarding compliance activities or submissions by performing field inspections and investigating citizen complaints.
- Plan and coordinate independent or team investigations and inspections that may involve disease outbreak.
- Provide reports of findings in support of case development and activities related to legal and administrative actions.
Candidate Info
4
years in workforce
2
years at this job
BS
Biomedical Engineering, Mathematics
MS
Biomedical Engineering
Biomedical Engineer/ Consumer Safety Officer
- Independently performed challenging surveillance and compliance inspections in the medical device and food
- Utilized the QSIT approach during device inspections to evaluate controls in management, design, process & production, and corrective & preventative actions.
- Contributing team member of multiple high-priority/special/emergency assignments, coordinating efforts, and deployed into the field within 24 hours.
- Authored inspectional observations FDA-483, affidavits, and other report outputs for final release supported by evidence and captured photographs in case development.
- Performed for-cause field investigations of vein removal medical device and other consumable products.
- Performed inspections in program areas of drugs, bioresearch monitoring clinical trials, veterinary medicine, and biologics.
- Led recall audit checks to ensure their effectiveness, responsible for maintaining inspection tools, being prepared for unexpected field events and processing and investigating consumer complaints.
- Aseptically collected surveillance and environmental samples for analysis of quality, filth, microbiology, chemistry, metal toxins, mycotoxins, aflatoxins, and other toxins.
- Actively participated in a courtesy meeting involving FDA management and a device firm's management team for discussing resolutions to compliance issues.
- Providing prompt and professional service to internal and external customers through open and transparent communication.
Candidate Info
7
years in workforce
7
years at this job
BS
Biology
Consumer Safety Officer
Independently and collaboratively conduct regulatory inspections and in-depth investigations of various industry establishments for foods, over-the-counter drugs, medical gases, pre-approval drugs, compounding pharmacies, animal drugs, post-marketing adverse drug events, bioresearch monitoring of PIs, contract pharmaceutical analytical laboratories, and registered blood collection facilities.
- Ensure product and efficacy compliance with FD&C Act, cGMPs, GCPs, GLPs, and other concepts applicable to inspectional and investigative techniques
- Identify deficiencies on FDA Form 483-Inspectional Observations in compliance with Federal laws, rules, and regulations, i.e. Significant GMP deficiencies in the quality system, failure to document inform consent, inadequate food processing control, personnel related food safety deficiencies, etc.
- Investigate complaints of injury, illness, or death caused by an FDA-regulated product
- Prepare final reports, position papers and other written documentation that support investigative findings and recommendations for further review by the Compliance Branch.
- Perform recall effectiveness audit checks
- Communicate information about the laws and policies of the FDA to consumers, industry, and related government agencies in the interest of the promotion of public health.
- Investigation for Bioresearch Monitoring of PI resulted in an untitled letter
- Inspection at an acidified manufacturer resulted in an untitled letter
- Inspection at an OTC manufacturer resulted in an untitled letter
- Inspection at a ready-to-eat food processor resulted in a warning letter
Candidate Info
20
years in workforce
1
year at this job
BA
Biology
Consumer Safety Officer
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
Candidate Info
9
years in workforce
2
years at this job
BS
Bachelor of Science
MA
Ebusiness And Global Management
MS
Chemistry
Consumer Safety Officer
Conduct independent inspections ensuring current GMP and HACCP at food, juice and seafood facilities and trained in Bovine Spongiform Encephalopathy (BSE) auditing
- Write inspectional reports, investigative memos and audit reports
- Ensuring safe and effective product recalls
- Analyze SOPs, HACCP plans, review all documents and records, and collect evidence and samples to support regulatory action
- Attended specialized training to aid with conducting quality inspections
Candidate Info
5
years in workforce
5
years at this job
BS
Business And Management
Consumer Safety Officer and Inspector in Charge
Consumer Safety Inspector for slaughtered and processed multiple species and exotic species: chicken, turkey, farm raised and feral hogs, cows, buffalo, bison, goat, ostrich, emu, and deer.
- Inspected multiple HACCP Plans, daily slaughter, pre-operational & operational sanitation inspections, procedure schedule.
- Submitted and conducted daily, weekly, and monthly on-site lab samples for Salmonella, baseline E-coli, Residue, RTE, Raw Ground and Not Ground.
- Experienced working knowledge of compliance, inner agency and plant personnel during Food Safety Audits (FSA) and Notice Of Intended Enforcement (NOIE).
- Team player with organizational & analytical skills, Laboratory & Quality Control, Sanitation, Food Safety, R&D and Production Floor.
- Proficient in knowledge of Regulatory Issues, HACCP, GMP's, A.I.B, USDA, SSOP's and SPC within slaughter and processed/packaged food.
- Familiar with PFF (Protein Fat Free) Control Program to improve the quality control and manufacturing process for ham processors.
- Calculated and analyzed PFF and CUSUM values to comply with PFF Regulations.
- Observed and verified product formulations, blending, processing, net weights, labeling and packaging measures.
Candidate Info
1
year in workforce
1
year at this job
BS
Biology
Consumer Safety Officer
- Performed on the job training and computer based training to ensure the safety of public health
- Completed Basic Federal Regulations training in the Code of Federal Regulations, Compliance Program Manual, Food, Drug, and Cosmetics Act, and other applicable regulations during an investigation
- Conducted individual recall audit checks, aseptic sample collections for pesticide, mycotoxin, and aflotoxin analysis
- Conducted group inspections with senior investigators for biologics, food, and tissue establishments
- Windows XP/Vista/7
- Mac OS 10.0 +
- Proficient in Microsoft Word, Excel, PowerPoint, Advanced Internet Research
- Familiar with HTML, Adobe Photoshop
Candidate Info
12
years in workforce
6
years at this job
BS
Audiology
MA
Environmental And Occupational Health
International Food Laws & Regulations
Consumer Safety Officer, Food Drug Administration
- Provide data entry of Centers inspection programs with quality assurance retrieval and analysis of information entered into the Field Accomplishments and Compliance Tracking System (FACTS). Analyzes data on international inspections in the FACTS in order to determine program accomplishments, trends, and problems
- Evaluate electronic Prior Notice data information from food shipments to ensure regulatory compliance.
- Research, navigate, and extract information from all national databases both within and outside the Agency.
- Provide liaison with a variety of stakeholders, including Customs and Border Protection, and industry/trade involved in importation of food shipments to the United States.
- Handle incoming telephone calls and advise various industry officials on rules and regulations and recommend any changes that must be made in compliance.
- Prepare recommendations and briefings for import alerts, civil actions, and coordinate detentions for volatile products offered for import.
Candidate Info
9
years in workforce
3
months at this job
BS
Biochemistry
Consumer Safety Officer (drug Specialist) - GDUFA
- Provide GMP guidance to industry.
- Develop, monitor, coordinate, and implement FDA Agency policy and initiatives in relation to human or veterinary pharmaceutical products ensuring compliance with FDA laws and regulations.
- Conduct quality assurance inspections of domestic and international manufacturing processes and write establishment inspection reports (EIRs) and recommendations for classifications.
- Plan, conduct and direct highly technical, complex inspections related to production, control, testing and processing human or veterinary pharmaceutical products.
- Perform investigations involving complaints or injury/death.
- Conduct complex and in-depth investigations, determine required course of action and level of investigative efforts required.
- Document inspection findings in prescribed written format according to FDA policies and guidelines.
- Maintain a working knowledge and awareness of the Current Good Manufacturing Practices objectives (cGMPs) and exercise analytical judgement to anticipate potential problems.
Candidate Info
27
years in workforce
18
years at this job
HS
High School Diploma
Consumer Safety Officer
Provide written and oral interpretation on FDA regulations.
- Promote scientific and regulatory guidance pertaining to FD&C Act.
- Update clients on the progress of their marketing applications.
- Assist in administration support to Center for Devices Division.
- Prepare fax and email correspondence to medical/clinical industry.
- Respond to telephone request from staff regarding fact sheets.
- Produce manufacturers' industry reports.
- Serve as Freedom of Information Act officer to public sector.
- Participate in focus group sessions to support Agency's Strategic Plan.
- Create project management plans and timelines quarterly.
- Work closely with other government and non-government agencies.
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